chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Diarrhoea, Dizziness, Muscle spasms, Nausea
Clinical narrative: Extreme dizziness - couldn't stand up w/o feeling like I was going to pass out.  Nausea, diarrhea, stomach cramps.  Dizziness and diarrhea continued the next day.  Shot was on Tuesday and symptoms continued thru Wednesday.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Dysstasia, Nausea
Clinical narrative: Patient contacted our medical office on 3/13/25 at 10:15 a.m.   See phone note from RN pasted below:  Received VM from pt stating wanting pt results and has question with RSV vaccine received in clinic.  Spoke with pt and she states had an adverse reaction to her RSV vaccine on 3/11/25. Pt states she went to work after receiving shot in morning, Tuesday pt states started feeling nausea with cramping, feeling dizzy, felt like she was going to vomit and afraid of falling when going to bathroom, so sat with her head at her desk for a while. Pt states did end up making it to bathroom, did not vomit, had diarrhea, continued to feel dizzy off and on. Pt states wasn't sure she would be able to drive home, however she was able to.  Yesterday pt still felt lightheaded, dizzy and diarrhea. Today pt states feels fine. Pt completing reaction form and vaccine information given to pt regarding details on shot information.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Diarrhoea, Dizziness, Muscle spasms, Nausea
Clinical narrative: Patient contacted our medical office on 3/13/25 at 10:15 a.m.   See phone note from RN pasted below:  Received VM from pt stating wanting pt results and has question with RSV vaccine received in clinic.  Spoke with pt and she states had an adverse reaction to her RSV vaccine on 3/11/25. Pt states she went to work after receiving shot in morning, Tuesday pt states started feeling nausea with cramping, feeling dizzy, felt like she was going to vomit and afraid of falling when going to bathroom, so sat with her head at her desk for a while. Pt states did end up making it to bathroom, did not vomit, had diarrhea, continued to feel dizzy off and on. Pt states wasn't sure she would be able to drive home, however she was able to.  Yesterday pt still felt lightheaded, dizzy and diarrhea. Today pt states feels fine. Pt completing reaction form and vaccine information given to pt regarding details on shot information.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Vision blurred
Clinical narrative: PATIENT CLAIMS SHE HAD BLURRED VISION AND CONSTRICTED BREATHING FOR 36 HOURS AFTER VACCINE. SHE DID NOT REPORT TO ANY MEDICAL PROFESSIONAL
Age: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient mistakenly received the Tdap vaccine instead of the ordered Dtap.
Age: 56.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Balance disorder, Body temperature decreased, Dizziness, Eye irritation
Clinical narrative: I noticed first i was a little dizzy and i had some balance issues, I would be walking and this was around 10 and i was walking back from the store. And it was bad enough that for a couple mins i had to rest against the wall. The dizziness was in my head but the balance issues was like i wasn't able to control my legs very well. In additional i started having a itchy and burning issues in my eyes and my vision got blurry, and there is a lot of pressure, and they have kept going off and on since then. After 1 am i started having a really bad headache and its not responding to meds, I also have had a swollen and sore throat. The balance issues they have manifested i could be standing somewhere and then my body doesn't wanna continue standing. and my legs just weak, My body temp is low and i am now running a low grade fever. and nothing has been helping bring that down. Inflammation and pain for joint pain. Tenderness on whole body.
Age: 56.0
Sex: M
Vaccine: HPV9
Symptoms: Eye pruritus, Headache, Inflammation, Loss of control of legs, Muscular weakness
Clinical narrative: I noticed first i was a little dizzy and i had some balance issues, I would be walking and this was around 10 and i was walking back from the store. And it was bad enough that for a couple mins i had to rest against the wall. The dizziness was in my head but the balance issues was like i wasn't able to control my legs very well. In additional i started having a itchy and burning issues in my eyes and my vision got blurry, and there is a lot of pressure, and they have kept going off and on since then. After 1 am i started having a really bad headache and its not responding to meds, I also have had a swollen and sore throat. The balance issues they have manifested i could be standing somewhere and then my body doesn't wanna continue standing. and my legs just weak, My body temp is low and i am now running a low grade fever. and nothing has been helping bring that down. Inflammation and pain for joint pain. Tenderness on whole body.
Age: 56.0
Sex: M
Vaccine: HPV9
Symptoms: Ocular discomfort, Oropharyngeal pain, Pharyngeal swelling, Pyrexia, Tenderness
Clinical narrative: I noticed first i was a little dizzy and i had some balance issues, I would be walking and this was around 10 and i was walking back from the store. And it was bad enough that for a couple mins i had to rest against the wall. The dizziness was in my head but the balance issues was like i wasn't able to control my legs very well. In additional i started having a itchy and burning issues in my eyes and my vision got blurry, and there is a lot of pressure, and they have kept going off and on since then. After 1 am i started having a really bad headache and its not responding to meds, I also have had a swollen and sore throat. The balance issues they have manifested i could be standing somewhere and then my body doesn't wanna continue standing. and my legs just weak, My body temp is low and i am now running a low grade fever. and nothing has been helping bring that down. Inflammation and pain for joint pain. Tenderness on whole body.
Age: 56.0
Sex: M
Vaccine: HPV9
Symptoms: Vision blurred
Clinical narrative: I noticed first i was a little dizzy and i had some balance issues, I would be walking and this was around 10 and i was walking back from the store. And it was bad enough that for a couple mins i had to rest against the wall. The dizziness was in my head but the balance issues was like i wasn't able to control my legs very well. In additional i started having a itchy and burning issues in my eyes and my vision got blurry, and there is a lot of pressure, and they have kept going off and on since then. After 1 am i started having a really bad headache and its not responding to meds, I also have had a swollen and sore throat. The balance issues they have manifested i could be standing somewhere and then my body doesn't wanna continue standing. and my legs just weak, My body temp is low and i am now running a low grade fever. and nothing has been helping bring that down. Inflammation and pain for joint pain. Tenderness on whole body.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Blister, Burning sensation, Cerebrovascular accident
Clinical narrative: pt says she became nauseated and her arm and shoulder area hurt really bad.  About a month after that she was hospitalized for a stroke. She was in Hospital (10 days) and then transferred to another hospital (10 days) and then to rehab (1 month) rehab center .  She then moved and after a couple of months. She noticed that her body was changing. She then developed blisters and rash on her buttocks and between her legs. She was itching and scratching it. It cleared up eventually. She has pain and burning within the body in her hand, shoulder, back, arm and legs that will not go away. She was given cream meds and pain medication for it but it doesn't help much.  She was told to follow up with her doctor and she is going to ask for a specialist.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Laboratory test, Nausea, Oesophagogastroduodenoscopy, Pain in extremity, Rash
Clinical narrative: pt says she became nauseated and her arm and shoulder area hurt really bad.  About a month after that she was hospitalized for a stroke. She was in Hospital (10 days) and then transferred to another hospital (10 days) and then to rehab (1 month) rehab center .  She then moved and after a couple of months. She noticed that her body was changing. She then developed blisters and rash on her buttocks and between her legs. She was itching and scratching it. It cleared up eventually. She has pain and burning within the body in her hand, shoulder, back, arm and legs that will not go away. She was given cream meds and pain medication for it but it doesn't help much.  She was told to follow up with her doctor and she is going to ask for a specialist.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Rash pruritic
Clinical narrative: pt says she became nauseated and her arm and shoulder area hurt really bad.  About a month after that she was hospitalized for a stroke. She was in Hospital (10 days) and then transferred to another hospital (10 days) and then to rehab (1 month) rehab center .  She then moved and after a couple of months. She noticed that her body was changing. She then developed blisters and rash on her buttocks and between her legs. She was itching and scratching it. It cleared up eventually. She has pain and burning within the body in her hand, shoulder, back, arm and legs that will not go away. She was given cream meds and pain medication for it but it doesn't help much.  She was told to follow up with her doctor and she is going to ask for a specialist.
Age: 0.42
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: first Influenza dose was given at age 5.5 months.   It was ultimately counted as an invalid dose, and the correct first dose was given 3/13/25.  No adverse events occurred, but dose was given at invalid date of age
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary arterial stent insertion, Coronary artery occlusion, Myocardial infarction
Clinical narrative: Heart Attack. 100% Blockage of RCA. Total of 3 stents placed in the RCA. Taking Anti-coagulants. lifetime pharma recipient as a result.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Incorrect vaccine was given. Hep B was ordered, but Hep A was given.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient has private Insurance so I know it has to be from non-vfc stock, but unfortunately, I grabbed FluB instead of Flupf. So 2 year ol patient received the FluB, Parents were notified, also Dr. I called parent's of child a few day after and they stated that no allergic reaction.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria, Vulvovaginal pain, Vulvovaginal swelling
Clinical narrative: 3/11/2025(Vaccination date at 9:40a) with two nurses that didn't not inform me of MMR and Varicella containing traces of egg, 3/12/24 (Called on-call nurse),  My daughter had a quarter size hive in-between her vaginal and naval; cluster of hives from the top of her butt to her ankle on both legs; pain and swelling in vaginal area, 2.5ml Benadryl administer at 6:30pm, 12:30am, 6:30am, & 12:30pm 3/13/25 (Follow up appointment at 9;40am) I requested that the incident be recording on her file along with a restriction for any medications or vaccines with any of her know allergies along with a note to excuse her from any other busters regarding MMR, Varicella, the active Flu vaccine, and any vaccination containing yeast, egg, or nut. I was told that everything was recorded, and that the incident was a mild reaction since there was no trouble breathing or swelling in the face. The Benadryl administrated at home has contained the issue at hand that could have been very severe since my daughter has a 45.80% allergy to egg white and 30.90% allergy to egg yolk which was presented to the clinic last year from the testing done at the allergist recommended by a previous pediatrician.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine was administered. Provider entered orders than canceled and reentered. Provider ordered covid-19 for patient. And Flu was administered. Provider was notified
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Arteriosclerosis, Carotid artery stenosis, Cerebral artery occlusion, Cerebral atrophy, Cerebral infarction
Clinical narrative: Woke on morning of 2/27/25 feeling tired, "something is wrong", napped four hours. Woke and worked in office, trying to read and couldn't make sense of written language. Went to ED for workup.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Cerebral small vessel ischaemic disease, Cognitive disorder, Computerised tomogram head abnormal, Fatigue, Feeling abnormal
Clinical narrative: Woke on morning of 2/27/25 feeling tired, "something is wrong", napped four hours. Woke and worked in office, trying to read and couldn't make sense of written language. Went to ED for workup.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Impaired work ability, Magnetic resonance imaging head abnormal, Scan with contrast abnormal, Vertebral artery stenosis, White matter lesion
Clinical narrative: Woke on morning of 2/27/25 feeling tired, "something is wrong", napped four hours. Woke and worked in office, trying to read and couldn't make sense of written language. Went to ED for workup.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Gastrointestinal viral infection, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: pt reported chills, pain in R arm and neck, tingling in fingers of same arm.  Treated with APAP and advil, cool compresses.  arm achey the following day.  However she concurrently developed a viral GI illness
Age: 0.67
Sex: M
Vaccine: DTAP, RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccination was given at 8m8d. Maximum age was exceeded. No adverse reaction at the time of this report. Mother to call with any concerning symptoms.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Contusion, Musculoskeletal stiffness, Pallor, Posture abnormal
Clinical narrative: He received Bexero first to the right arm. Patient requested HPV in the same arm.  He got the HPV vaccine to right arm.  He sat down in the chair next to his dad. MA walked to his computer and sat down. Dad began yelling for help. Patient was rigid/stiff, arms bent and fists inward, head back, mouth open, and was pale.  Both dad and MA got patient to the table. I (the provider) walked in as his legs were going up on the exam table. He  continued rigidity for another 15-30 seconds.  After the episode, he was awake, alert and said he was fine. He tried to brush it off that he tends to faint with pain.  He was not drowzy or confused. He told me he was fine.  VS were taken. Gave him some water and a lollipop.  Watched him for 10 more minutes before he left. Referred him to neurology and has an appointment in April.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: A red, warm, hard lump started forming at the injection site the night of the vaccination.  It progressively got larger and a not formed in under arm lymph node area also.  Patient was seen today by physician who diagnosed it as an allergic reaction to the vaccine and prescribed an oral steroid.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Diarrhoea haemorrhagic, Occult blood positive
Clinical narrative: Patient received vaccines in clinic on 8/12/2025. On 8/13/2025 around 7am patient developed numerous (>10) episodes of bloody diarrhea with some abdominal cramping. No fevers or vomiting. Still able to eat and drink. Presented to the local ED around noon on 3/13/2025. Hemoccult was positive.
Age: 11.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Inadvertent and extraneous dose administered. No other adverse events noted.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: There was no adverse reaction noted-   vaccination given after BUD 2/28/25.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of Menquadfi at age 16 which was not necessary, due to first dose being given at age 16.  Pt is doing well.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Angioedema
Clinical narrative: angioedema
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Pallor, Syncope, Tachycardia, Unresponsive to stimuli
Clinical narrative: Right after the vaccine administration, she fainted, she was pale and unresponsive. She had to be stimulated, placed in supine position with legs elevated, her Blood pressure dropped to 77/47. Hr was tachycardic. It took her at least 15-20 minutes to be alert and her skin profusion improved and her blood pressure reading  was 109/69,HR 69. We were contemplating calling 911 and transferring to ER but mom preferred her to be monitored here. We offered her water and a popsicle. She was also fasting  for religion and was reluctant to break her fast. We monitored her for a total duration of about an hour in office.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Cough, Rash
Clinical narrative: RASH/COUGH
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Mouth swelling
Clinical narrative: Patient experienced numbness without swelling in corner of mouth approximately 10 minutes after vaccine administration with no other symptoms. Patient reported that numbness progressed to lower lip and nose over the next 5-10 minutes, but denies additional symptoms beyond numbness.  Patient was advised to visit the emergency room. Patient accepted this and was transported by woman who brought her to receive her vaccine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness
Clinical narrative: PATIENT PRESENTS DIZZINESS AND WEAKNESS
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: her whole upper arm became red and hot to the touch.   Somewhat painful and intermittently itchy. Offered patient topical steroid creams or oral medications to help with the pruritus, patient declines at this time and states she can use OTC medications - discussed use of supportive care, such as cold compresses, OTC analgesics like tylenol/ibuprofen, antihistamines or topical creams for itchiness  - discussed red flag symptoms to look for concerning for severe anaphylaxis that would require immediate attention, patient understanding   -Follow up as needed.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling and redness at injection site
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: 54-year-old male patient coming into the hospital after a traumatic fall off a ladder at work. Patient was seen in the hospital emergency department and received fentanyl 50 mcg for pain management and iohexol for contrast for CT imaging. After imaging, Tdap vaccine (Boostrix) was given by RN for tetanus prophylaxis as patient had unknown Tdap vaccine history. RN reports giving Tdap via intravenous route instead of intramuscular route after administration. Poison Control Center was contacted. Discussed concerns for possible anaphylaxis reaction when administering Tdap via intravenous route based on prior literature with patient. Patient was monitored for 3 hours after Tdap administration without any reports of adverse reactions. Pharmacist, RN, and MD were at bedside to discuss anaphylaxis symptoms and return precautions.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient states she got the vaccine and about 2 hours later her arm began to hurt. It got better after a day or so and then she started having trouble with her arm again. She said she got PT for the pain.
Age: 56.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Chills, Fatigue, Injection site cellulitis, Injection site discolouration, Injection site pain
Clinical narrative: Right upper arm tenderness, swelling, and discoloration with chills and fatigue.    Diagnosed with Cellulitis, was treated with oral Bactrim and mupirocin cream
Age: 56.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Injection site swelling
Clinical narrative: Right upper arm tenderness, swelling, and discoloration with chills and fatigue.    Diagnosed with Cellulitis, was treated with oral Bactrim and mupirocin cream
Age: 56.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Bone pain, Discomfort, Injection site discharge, Injection site erythema, Injection site pain
Clinical narrative: Right upper arm tenderness, swelling, and discoloration with chills and fatigue.    Diagnosed with Cellulitis, was treated with oral Bactrim and mupirocin cream
Age: 56.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Right upper arm tenderness, swelling, and discoloration with chills and fatigue.    Diagnosed with Cellulitis, was treated with oral Bactrim and mupirocin cream
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC20
Symptoms: Cerebellar ataxia, Magnetic resonance imaging head normal, Mumps antibody test positive, Parotitis
Clinical narrative: Developed right side parotitis and acute cerebellar ataxia that last 2-3 days
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Myalgia, Myositis
Clinical narrative: Patient reported Myositis. She stated full body weakness, muscle and joint pain starting on 1/18. This did not resolve after 8 days so she started a round of steroids. The steroids helped diminish symptoms, but she had a reaction to the steroids and had to stop. Joint pain returned when she stopped the steroids. Per patient symptoms have diminished for the last 3-4 weeks.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Malaise, Measles
Clinical narrative: 12 days after vaccination developed swelling in lymph nodes bilaterally next to ear with tenderness, then progressed  swelling of lymph nodes in neck, and back of head.  Continued swelling, having fatigue, malaise..  Fine papular rash developed all over neck, torso, back arms, face and ears .  Rash is itchy.  Edema in tonsils with Koplik spots, sore throat.  Progressed into swelling in glands behind right knee.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Oedema, Oropharyngeal pain, Rash papular, Rash pruritic
Clinical narrative: 12 days after vaccination developed swelling in lymph nodes bilaterally next to ear with tenderness, then progressed  swelling of lymph nodes in neck, and back of head.  Continued swelling, having fatigue, malaise..  Fine papular rash developed all over neck, torso, back arms, face and ears .  Rash is itchy.  Edema in tonsils with Koplik spots, sore throat.  Progressed into swelling in glands behind right knee.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Flushing
Clinical narrative: severe flushing, light-headedness within five minutes after injection, followed by lower back pain;  reaction abated within fifteen minutes and patient exited store under own volition.
Age: 56.0
Sex: M
Vaccine: PNC20
Symptoms: Electric shock sensation, Gait disturbance, Pain, Pain in extremity
Clinical narrative: Patient reported that morning after he received the vaccine that he had pain shooting down like electricity through both his legs and that he had difficulties walking. Patient stated that it did go away by Wednesday, patient declines calling anyone or getting treatment.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Bell's palsy, Blood test, Computerised tomogram head normal, Electrocardiogram
Clinical narrative: i was requested to get a shingals shot from insurance, my doctors office and  in emails . i called and was granted day of monday Febuary 24@ 2:pm.  recived shot continued shopping returned home dinner and bed.  Tuesday morning i was having a bell palsy event, call doc,  went to ER and was admitted to hospital . ct scan clear , no stroke, went home to rest.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red circle around the injection site, slightly warm to the touch
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Biopsy, Blood test, Computerised tomogram, Dyspnoea, Dysstasia
Clinical narrative: 11/28/2023 physical, weighed 150 lbs, dtap and shingles vaccine. Next day aches pains, fatigue, flu like symptoms, lethargic for 2 to 3 days. 12/02/2023 noticed legs swelling and getting worse. 12/05/2023 went to er for ultrasound no blood clots. 12/08/2023 admitted to hospital for edima and cardicac arrest but ended up being minimal kidney disease.  Did blood tests, xrays, catscan, mri and biopsy. released 12/13/2023.  Next 2 weeks sever edima. could not walk without assistance. couldn't eat or drink, swelled up. weighed 199 lbs. when admitted to hospital 12/30/2023.  couldn't walk, eat, drink, difficult breathing,  Blood test, xrays, mri, catscans, and every other test they could do. Released on 01/09/2024.  After release had to see a heart doctor and a cancer doctor both turned out to be normal.  Still have minimal kidney disease today. Chronic pain throughout body, hard to get up, fatigue, and edima.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Feeding disorder, Gait disturbance, Gait inability, Influenza like illness
Clinical narrative: 11/28/2023 physical, weighed 150 lbs, dtap and shingles vaccine. Next day aches pains, fatigue, flu like symptoms, lethargic for 2 to 3 days. 12/02/2023 noticed legs swelling and getting worse. 12/05/2023 went to er for ultrasound no blood clots. 12/08/2023 admitted to hospital for edima and cardicac arrest but ended up being minimal kidney disease.  Did blood tests, xrays, catscan, mri and biopsy. released 12/13/2023.  Next 2 weeks sever edima. could not walk without assistance. couldn't eat or drink, swelled up. weighed 199 lbs. when admitted to hospital 12/30/2023.  couldn't walk, eat, drink, difficult breathing,  Blood test, xrays, mri, catscans, and every other test they could do. Released on 01/09/2024.  After release had to see a heart doctor and a cancer doctor both turned out to be normal.  Still have minimal kidney disease today. Chronic pain throughout body, hard to get up, fatigue, and edima.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Lethargy, Magnetic resonance imaging, Nephropathy, Oedema, Pain
Clinical narrative: 11/28/2023 physical, weighed 150 lbs, dtap and shingles vaccine. Next day aches pains, fatigue, flu like symptoms, lethargic for 2 to 3 days. 12/02/2023 noticed legs swelling and getting worse. 12/05/2023 went to er for ultrasound no blood clots. 12/08/2023 admitted to hospital for edima and cardicac arrest but ended up being minimal kidney disease.  Did blood tests, xrays, catscan, mri and biopsy. released 12/13/2023.  Next 2 weeks sever edima. could not walk without assistance. couldn't eat or drink, swelled up. weighed 199 lbs. when admitted to hospital 12/30/2023.  couldn't walk, eat, drink, difficult breathing,  Blood test, xrays, mri, catscans, and every other test they could do. Released on 01/09/2024.  After release had to see a heart doctor and a cancer doctor both turned out to be normal.  Still have minimal kidney disease today. Chronic pain throughout body, hard to get up, fatigue, and edima.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Peripheral swelling, Swelling, Ultrasound Doppler normal, X-ray
Clinical narrative: 11/28/2023 physical, weighed 150 lbs, dtap and shingles vaccine. Next day aches pains, fatigue, flu like symptoms, lethargic for 2 to 3 days. 12/02/2023 noticed legs swelling and getting worse. 12/05/2023 went to er for ultrasound no blood clots. 12/08/2023 admitted to hospital for edima and cardicac arrest but ended up being minimal kidney disease.  Did blood tests, xrays, catscan, mri and biopsy. released 12/13/2023.  Next 2 weeks sever edima. could not walk without assistance. couldn't eat or drink, swelled up. weighed 199 lbs. when admitted to hospital 12/30/2023.  couldn't walk, eat, drink, difficult breathing,  Blood test, xrays, mri, catscans, and every other test they could do. Released on 01/09/2024.  After release had to see a heart doctor and a cancer doctor both turned out to be normal.  Still have minimal kidney disease today. Chronic pain throughout body, hard to get up, fatigue, and edima.
Age: 36.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Left arm reaction, soreness and redness since vaccination on 3/7/25, but upon awakening on 3/12/25 the area had marked increased redness/swelling/warmth as compared to previous night. Pharmacy recommended pt contact PCP, PCP prescribed Keflex
Age: 71.0
Sex: M
Vaccine: RSV, VARCEL
Symptoms: Dizziness
Clinical narrative: Pt call Thursday complaining  of dizziness. Pt explained that the dizziness started the day after the vaccinations and was wanting to know how long he symptoms would last.  Pt further explained that the dizziness only occurred when his eyes were open. Pt was directed to immediate medical care for evaluation/treatment.
Sex: F
Vaccine: PNC21
Symptoms: Chills, Pain, Pain in extremity, Urticaria
Clinical narrative: having body aches/ she couldn't do anything due to the pain of the body aches; Patient woke the next day with her arm very sore; Patient experiencing chills to the point that her lips were chattering; Patient indicated that the liquid "hurt when going in; Size of the welt on her arm is 4 "long and 3.5"/ the injection spot is still raised, red and grew since yesterday; This spontaneous report has been received from a patient of 59-years-old referring to herself. Patient's concomitant medications included "a statin" and multi vitamins. There was no information about medical history or previous drug allergies.    On 10-FEB-2025 at 3:00pm, patient was vaccinated as recommended by her HCP with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) formulation as default as solution for injection (strength, exact dose, anatomical route of administration, lot # and expiration date was not reported).    Patient indicated that the liquid "hurt when going in" (injection site pain). Patient woke the next day (on 11-FEB-2025) with her arm very sore (pain in extremity).  She went to work but started experiencing chills to the point that her lips were chattering (chills) and was having body aches (pain), so she decided to go home.  By 12-FEB-2025 she "could not do anything" due to the pain of the body aches and chills so she didn't go to work.  Patient stated that as of today the chills are gone, but the size of the welt on her arm is 4" long and 3.5" (vaccination site urticaria) wide and she is still experiencing body aches.  The injection spot is still raised, still red, and grew since yesterday (12-FEB-2025).  Patient had not contacted her HCP because when reading the PI she saw that 1% of people have side effects.  She felt she fell in that 1%.  Patient felt it was irrelevant to supply HCP contact information but did authorize contact with her.   The outcome of the event vaccination site pain and urticaria was considered as not recovered, while for the event pain and injection site pain was unknown.   On an unspecified date in February 2025, the patient was recovered from the event chills.   The causal relationship between aforementioned adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.   Lot number is being requested and will be submitted if received.
Age: 69.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Patient thought she was having a reaction as she is allergic to preservatives, but did see there were no preservatives listed in the vaccine.; possible infection; This spontaneous report was received from a consumer and refers to a 69-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions included Rheumatoid arthritis. Historical drugs included adalimumab (Humira), rituximab (Rituxan), and Contrast media. Concomitant medications included atorvastatin calcium, amlodipine and atorvastatin (Amlodipine besilate (+) atorvastatin calcium), clonidine, levothyroxine sodium (synthroid), fexofenadine hydrochloride (Allegra), estriol, famotidine, calcium carbonate (Caltrate), ergocalciferol (Vitamin D), lactobacillus acidophilus (Acidophilus), folic acid, and prednisolone.  On 09-Feb-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Injection (CAPVAXIVE) (strength, formulation, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis.   On 09-Feb-2025, the patient initially had a minor irritation at the injection spot and couldn't sleep. On 10-Feb-2025 (Monday), the arm swelled up, her skin was very tight due to the swelling, the arm was hot & red (like a giant red hive) and was continuing to spread. The patient indicated she could not lift her arm. Therefore, patient went to her cardiologist on 11-Feb-2025 (Tuesday), as the swelling was almost under the arm. The cardiologist prescribed methylprednisolone (SOLUMEDROL) which worked until it wore off. The arm again became hot, red and swollen. The patient thought she was having a reaction as she was allergic to preservatives but did see there were no preservatives listed in the vaccine (Hypersensitivity). The patient was placed on cefalexin (KEFLEX) (500 m/4 times a day) in a case of an infection (infection unspecified (NOS) and prednisone (higher dose than currently taking). The patient sought medical attention and was to the emergency department. At the reporting time, the patient still had swelling (not recovered from hypersensitivity event). The outcome of the event of infection NOS was not provided.    The causal relationship between the events with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: her face was paralyzed for almost a year; This serious case was reported by a consumer via interactive digital media and described the occurrence of facial paralysis in a adult female 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 facial paralysis (Verbatim: her face was paralyzed for almost a year) (serious criteria GSK medically significant and other: Serious as per reporter). The outcome of the facial paralysis was resolved.   The reporter considered the facial paralysis to be related to Shingrix.     The company considered the facial paralysis to be unrelated to Shingrix.   Additional Information: GSK receipt date: 09-MAR-2025 This case was reported by a patient's sister via interactive digital media. The patient got it (Shingrix) and her face was paralyzed for almost a year.; Sender's Comments: Facial paralysis   is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-FEB-2024 This case was reported by a patient via interactive digital media. The patient stated that they received the Shingrix vaccine and still got shingles, it was horrible.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Post procedural infection, Pruritus, Urticaria
Clinical narrative: infection from the oral surgery; Hives all over her body; Itching; Trouble breathing; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included oral surgery. Concomitant products included ibuprofen (Motrin).   On 25-FEB-2025, the patient received the 1st dose of Shingrix. On 03-MAR-2025, 6 days after receiving Shingrix and 1 days after starting clindamycin, the patient experienced generalized urticaria (Verbatim: Hives all over her body). In MAR-2025, the patient experienced pruritus (Verbatim: Itching) and difficulty breathing (Verbatim: Trouble breathing). On an unknown date, the patient experienced postoperative infection (Verbatim: infection from the oral surgery). The patient was treated with clindamycin and diphenhydramine hydrochloride (Benadryl). The outcome of the generalized urticaria, pruritus, difficulty breathing and postoperative infection were not resolved.   It was unknown if the reporter considered the generalized urticaria, pruritus, difficulty breathing and postoperative infection to be related to Shingrix.     It was unknown if the company considered the generalized urticaria, pruritus, difficulty breathing and postoperative infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAR-2025 The patient self-reported this case. The patient wanted to get back to the emergency room. The patient's sister was the main reporter, but the patient also took part in the conversation, so the reporter details were that of the patient. The patient had the first dose of Shingrix last Tuesday on 25 February 2025. The patient also had oral surgery the same day. The patient was started on Clindamycin on Sunday on 02 March 2025 due an infection from the oral surgery. It was unclear if the patient was taking another antibiotic prior to the Clindamycin.  The patient also had been taking Motrin and an unnamed nausea medication due to the oral surgery.  On Monday 03 March 2025 the patient stated to experience hives. At 5:30 am this morning 04 March 2025 the patient went to the emergency room with complaints of severe hives which were all over her body, trouble breathing, and itching. The patient was given steroids and IV Benadryl while in the emergency room. Since being home from the emergency room, the patient was using anti-itch spray and took an epsom salt bath. Since the patient was not getting better, the patient was going back to the emergency room for further evaluation. Reporter consent to contact was not given.
Age: 0.58
Sex: F
Vaccine: MENB, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received first dose of Bexsero at 7 months and the second dose after a year; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-month-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero and the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero and Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: received first dose of Bexsero at 7 months and the second dose after a year). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 05-MAR-2025 The patient was 3 years and 10 months of age. The reporter had a child who received first dose of Bexsero at 7 months and the second dose after a year, which led to inappropriate age at vaccine administration. The reporter asked that was this safe or she should get another dose.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ulcer, Vaccination failure
Clinical narrative: Suspected vaccination failure; keeps getting shingles 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: keeps getting shingles on his face). The outcome of the vaccination failure and facial herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix.     The company considered the vaccination failure and facial herpes zoster to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 09-MAR-2025 This case was reported by a patient via interactive digital media. The reporter's brother received Shingrix vaccines and now he keeps getting shingles on his face. He ends up with sores. It sounds like you can't win. The reporter haven't had the vaccine himself and was still debating. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix vaccine.
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Product preparation error
Clinical narrative: administered only the sterile water for injection component of the Priorix vaccine; administered only the sterile water for injection component of the Priorix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old male patient who received MMR (Priorix) (batch number A2J35, expiry date 01-SEP-2025) for prophylaxis.   On 02-MAR-2025, the patient received Priorix. On 02-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the sterile water for injection component of the Priorix vaccine) and inappropriate dose of vaccine administered (Verbatim: administered only the sterile water for injection component of the Priorix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   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 : 03-MAR-2025 The patient was administered only the sterile water for injection component of the Priorix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2025026202, reported by same reporter different patient.; Sender's Comments:  US-GSK-US2025026202:Same reporter/Diffrent patient
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: fever; pain; Fatigue; myalgia; malaise; this as Late 2nd dose; This non-serious case was reported by a nurse and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JX9Z) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12-OCT-2018) and Covid 19 vaccine (received on an unknown date).   On 29-JUL-2019, the patient received the 2nd dose of Shingrix. On 29-JUL-2019, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: this as Late 2nd dose). On an unknown date, the patient experienced fever (Verbatim: fever), pain (Verbatim: pain), fatigue (Verbatim: Fatigue), myalgia (Verbatim: myalgia) and malaise (Verbatim: malaise). The outcome of the fever was unknown and the outcome of the pain, fatigue, myalgia and malaise were not reported and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the fever, pain, fatigue, myalgia and malaise to be related to Shingrix.     It was unknown if the company considered the fever, pain, fatigue, myalgia and malaise to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAR-2025 and 04-MAR-2025 The nurse Anesthetist called and reported that she have an incomplete record for 2nd Shingrix dose, she have a lot number and a date, but nobody would admit to have given that shot, and shot need a complete record for the employment and they want to see that. So if nobody admit that they gave the shot and amend records the patient gonna have to get a 3rd shot, was that gonna be harmful. She mentioned that when she got the vaccines, she had fever.  After the second vaccine, they suffered from pain, fatigue, myalgia, malaise and that every time they suffered ever, as well as every time they received the COVID vaccine.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patient; Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB043A, expiry date 31-JUL-2025) for prophylaxis.   On 03-MAR-2025, the patient received Menveo. On 03-MAR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patient) and inappropriate dose of vaccine administered (Verbatim: Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 05-MAR-2025 The reporter stated that on Monday, 3rd March 2025 Menveo (orange cap vial-lyophilized) was mixed with sterile water diluent and administered to a patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.