chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old was given 0.25ml of Spikevax.  No adverse reactions noted. The Clinical Considerations for Use of COVID-19  Vaccines in the country was document that was referenced for ability to give the Spikevax on pg 3/20 Ages 5-11: "1 dose of an updated (2023-2024 Formula) mRNA vaccine from either manufacturer (ie., Moderna )".  Stopping here and finding dose for 7 year old of 0.25ml pharmacist missed the fact it had to be from Moderna the authorized vaccine instead of being drawn from Spikevax also manufactuered by Moderna, the approved vaccine which was only for 12 years and up.  Medical Information stated the formulation and all excipients for Spikevax (per Moderna's Medical Information Department) To clarify statement above: Medical Information was contacted after error found on 2/7/2024.
Age: 70.0
Sex: F
Vaccine: FLU4, RSV, UNK
Symptoms: Cough, Influenza like illness, Pain
Clinical narrative: Started with flu like symptoms , body aches then turned into Constant Coughing which may be caused by acid reflux however symptoms did not exist prior to shots and have lasted now for 3 weeks
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Nausea
Clinical narrative: nausea and abdominal pain
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Pain at injection site and L elbow. Hard lump, Erythema, and swelling at injection site.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Pain at injection site and L elbow. Hard lump, Erythema, and swelling at injection site.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered. Beyond use date of 2/4/24 and vaccine administered on 2/7/24.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: After about a week, patient woke up with muscle pain of right arm. She cannot lift right arm above a 45 degree angle. She feels pain as she moves her arm up. She cannot lift cell phone with right arm without pain.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Computerised tomogram head, Echocardiogram
Clinical narrative: Blood pressure spikes daily. High heart rate spikes also.  Headaches daily for 6 weeks. 5 ER visits with BP as high as 225 over 125. Treatment various BP meds. Outcome poor after 3 plus years but improvment.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Headache, Heart rate increased
Clinical narrative: Blood pressure spikes daily. High heart rate spikes also.  Headaches daily for 6 weeks. 5 ER visits with BP as high as 225 over 125. Treatment various BP meds. Outcome poor after 3 plus years but improvment.
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vaccine pulled under correct order dose but the error was in the actual registering the vaccine into system, when vaccine arrived to clinic. there were two different doses, 100ml and 50ml but only the 50ml was scanned into system with the impression that both boxed of RSV were the same dose. When vaccine was pulled to be administered between 2 medical personnel none caught the dose difference in time and so the that which was taken initially was administered.  further investigation on the same day mins after patient had left the error was discovered and parents were called and informed, date 2/6/24. Parents were also called on 2/7/24 to inquire about the health and well being of the child of which they reported that the child is doing well, no fevers, negative reactions or cause for concerns has been observed. they were encouraged to callk or come in or go to the ER if for any reason the state of the baby has changed in the form of fever or anything else.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain in extremity, Rash
Clinical narrative: Tired the evening of the vaccination. Then, the following day a rash broke out all over her chest. Her arm is also sore and has a red spot. Two days later, her family physician ordered Prednisone to stop the reaction.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: patient states the next day after vaccine she has had severe joint pain since.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness around vac site not walking as well as usual do to pain sacred to bear full weight on left leg  red, warm pt fussy when site is touched  mildly swollen
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Irritability
Clinical narrative: Redness around vac site not walking as well as usual do to pain sacred to bear full weight on left leg  red, warm pt fussy when site is touched  mildly swollen
Age: 59.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Blood test, Eye pain, Headache
Clinical narrative: EYE PAIN, HEAD PAIN, NO FEVER, NO SORES
Age: 48.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Feeling hot, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: Patient came in today stating she had leg pain and weakness and feeling unwell. she also said she had been feeling hot since saturday
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to surgical sutures, Basal cell carcinoma, Cancer surgery, Incision site discharge, Incision site erythema
Clinical narrative: I had a reaction to stitches in my face. I was diagnosed with basal cell carcinoma.  I went to the dermatology surgeon to have it removed.  The area turned red, oozed liquid, swelled up, and developed scar tissue.  My regular dermatologist said it was an inflammatory, auto-immune reaction.  I did not, prior to the vaccine, have any autoimmune diseases.  I had been tested extensively for auto-immune diseases in the past, and was completely normal.  After this reaction, I had to go back to the surgeon, have the scar tissue cut out.  The same thing happened again.  I still have scar tissue on my face.  Now, anytime I get a small scratch or wound, I end up with scar tissue.  I would be afraid to have any kind of surgery ever again, for fear of massive scar tissue.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incision site swelling, Inflammation, Scar
Clinical narrative: I had a reaction to stitches in my face. I was diagnosed with basal cell carcinoma.  I went to the dermatology surgeon to have it removed.  The area turned red, oozed liquid, swelled up, and developed scar tissue.  My regular dermatologist said it was an inflammatory, auto-immune reaction.  I did not, prior to the vaccine, have any autoimmune diseases.  I had been tested extensively for auto-immune diseases in the past, and was completely normal.  After this reaction, I had to go back to the surgeon, have the scar tissue cut out.  The same thing happened again.  I still have scar tissue on my face.  Now, anytime I get a small scratch or wound, I end up with scar tissue.  I would be afraid to have any kind of surgery ever again, for fear of massive scar tissue.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15
Symptoms: No adverse event, Product administration error
Clinical narrative: No adverse event happened, just an error in administration
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Eye swelling, Feeling abnormal, Pain in extremity
Clinical narrative: I spoke to patient who got their shingles vaccine yesterday on 2/6/24. She called in this evening on 2/7/24 stating she is experiencing pretty severe symptoms from the vaccine including swelling of the face, eyes swollen redness in face, throat scratchy, fever, dizziness, arm is very sore and swollen. She said she feels very bad overall. She took benadryl earlier today and no improvement. I recommended she is seen this evening. She said she was planning on going when a family member came home. I also explained that if she would start to have any difficulties in breathing to call EMS.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling face, Throat irritation
Clinical narrative: I spoke to patient who got their shingles vaccine yesterday on 2/6/24. She called in this evening on 2/7/24 stating she is experiencing pretty severe symptoms from the vaccine including swelling of the face, eyes swollen redness in face, throat scratchy, fever, dizziness, arm is very sore and swollen. She said she feels very bad overall. She took benadryl earlier today and no improvement. I recommended she is seen this evening. She said she was planning on going when a family member came home. I also explained that if she would start to have any difficulties in breathing to call EMS.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: She had trouble breathing few minutes after giving vaccine. She was given an epi-pen and called EMS. She refused to go to the hospital.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after BUD date: 1/21/24. Date Spikevax move from freezer to fridge 12/22/23. Date administered 1/22/24.  Expiration date: 03/25/2024
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: patient received vaccination on 2/5/24 for covid-19 at 12:45pm  and noticed a reaction to the localized area of her left arm the morning of 2/6/24. she then came into the pharmacy on 2/7/24 in the afternoon to report the reaction. it was localzied redness and slightly warm to the touch and the patient reported the area was getting smaller. i told her to watch the area and report back to us if the area got an larger
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Swollen tongue, Syncope
Clinical narrative: Patient complained of tongue swelling, and difficulty breathing, and fainting about 20 minutes after vaccine was administered. Epipen was administered and emergency personnel came via ambulance.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after BUD date: 1/21/24. Date Spikevax move from freezer to fridge 12/22/23. Date administered 1/29/24.  Expiration date: 03/25/2024
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after BUD date: 1/21/24. Date Spikevax move from freezer to fridge 12/22/23. Date administered 1/22/24.  Expiration date: 03/25/2024.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Balance disorder, Encephalitis, Hypoacusis, Loss of consciousness, Magnetic resonance imaging head normal
Clinical narrative: Found unconscious 6 days after receiving vaccine.  Hospitalized for ten days, no cause found.  Treated with IV antibiotics, antiviral and steroid.   Final diagnosis encephalitis.  Eventually recovered but with some decrease in vision, hearing and balance.  Physicians unable to perform LP for diagnosis.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Magnetic resonance imaging spinal normal, Visual impairment
Clinical narrative: Found unconscious 6 days after receiving vaccine.  Hospitalized for ten days, no cause found.  Treated with IV antibiotics, antiviral and steroid.   Final diagnosis encephalitis.  Eventually recovered but with some decrease in vision, hearing and balance.  Physicians unable to perform LP for diagnosis.
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, aches, chills, headache
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Angiogram pulmonary normal, Brain natriuretic peptide, Chest discomfort, Chest pain, Differential white blood cell count normal
Clinical narrative: Unsure of type of flu shot, Covid booster confirmed Moderna with clinic. Tight chest by 12 hours in, chest ache/pain soon as well. Heart palpitations by 6 hours in. Both palpitations and chest tightness get worse over course of at least 2 days (issue is ongoing), easily winded walking up stairs, profuse night sweats, etc. Pain begins to spread down left arm and is concentrated in left chest as well. Worried. Called PCP and nurse said to go to ER. Was discharged, so apparently everything is normal (besides slightly elevated Ddine) or at least not urgent, will follow up with PCP. Patient, myself, worried about myocarditis, perhaps took the booster too close to a real Covid infection I had in mid December.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dyspnoea exertional, Electrocardiogram normal, Fibrin D dimer increased, Full blood count normal, Human chorionic gonadotropin normal
Clinical narrative: Unsure of type of flu shot, Covid booster confirmed Moderna with clinic. Tight chest by 12 hours in, chest ache/pain soon as well. Heart palpitations by 6 hours in. Both palpitations and chest tightness get worse over course of at least 2 days (issue is ongoing), easily winded walking up stairs, profuse night sweats, etc. Pain begins to spread down left arm and is concentrated in left chest as well. Worried. Called PCP and nurse said to go to ER. Was discharged, so apparently everything is normal (besides slightly elevated Ddine) or at least not urgent, will follow up with PCP. Patient, myself, worried about myocarditis, perhaps took the booster too close to a real Covid infection I had in mid December.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Lipase normal, Metabolic function test normal, Musculoskeletal chest pain, Night sweats, Pain in extremity
Clinical narrative: Unsure of type of flu shot, Covid booster confirmed Moderna with clinic. Tight chest by 12 hours in, chest ache/pain soon as well. Heart palpitations by 6 hours in. Both palpitations and chest tightness get worse over course of at least 2 days (issue is ongoing), easily winded walking up stairs, profuse night sweats, etc. Pain begins to spread down left arm and is concentrated in left chest as well. Worried. Called PCP and nurse said to go to ER. Was discharged, so apparently everything is normal (besides slightly elevated Ddine) or at least not urgent, will follow up with PCP. Patient, myself, worried about myocarditis, perhaps took the booster too close to a real Covid infection I had in mid December.
Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Palpitations, Troponin normal
Clinical narrative: Unsure of type of flu shot, Covid booster confirmed Moderna with clinic. Tight chest by 12 hours in, chest ache/pain soon as well. Heart palpitations by 6 hours in. Both palpitations and chest tightness get worse over course of at least 2 days (issue is ongoing), easily winded walking up stairs, profuse night sweats, etc. Pain begins to spread down left arm and is concentrated in left chest as well. Worried. Called PCP and nurse said to go to ER. Was discharged, so apparently everything is normal (besides slightly elevated Ddine) or at least not urgent, will follow up with PCP. Patient, myself, worried about myocarditis, perhaps took the booster too close to a real Covid infection I had in mid December.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: High fever chills arthritic pain in front and back breathing problems and fatigue.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: redness, swelling  Treatment - Ibuprofen, Tylenol every 8 hours for 3 days.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Injection site erythema, Injection site swelling, Swelling
Clinical narrative: -left thigh had some redness and some swelling - localized
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccines given on 02/02/24 at 12:00 pm. At 2:00PM patient began with symptoms of adverse events. Patients left thigh was red and warm to touch. Redness extended out and was about the size of a tangerine". Leg appeared to be painful to touch. No fever. No medications or treatments given. Patient has improved.
Sex: M
Vaccine: RSV, RSV
Symptoms: Blood test, CSF protein increased, CSF test abnormal, Constipation, Enzyme level increased
Clinical narrative: Guillain-Barre Syndrome; Vaccination Site Pain/a small pain where he got the vaccine; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2730830-1 (VAERS ID).  A 67-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Nov2023 as dose 1, single (Lot number: 10L752F) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; METFORMIN HCL; GLIPIZIDE; OLMESARTAN MEDOXOMIL; LEVOTHYROXINE. The patient also took other concomitant therapy. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "Vaccination Site Pain/a small pain where he got the vaccine"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset 06Dec2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: Dec2023, discharge date: 29Dec2023, hospitalization duration: 17 day(s)). Patient got his vaccine, had a small pain where he got the vaccine, no AE until he started loosing the sensation in his legs. He called his doctor, that he thought it was a sciatic nerve. They felt it was something more serious. His neighbor is a neurosurgeon, who directed him to another hospital ER. In that ER (hospital) he had MRI of brain, spinal tap and they determined that he had Guillain Barre as his enzymes and protein in the spinal fluid was 400 where it should be 40. He was hospitalized for 17 days. It affected him where he could not have a bowel movement for 9 days, and now that has resolved with the plasma exchange. He had 7 treatment of plasmapheresis, and was discharged on 29Dec23 to a rehab center since 29Dec2023 and is supposed to be there until 20Jan2024 where he will be able to go home. The treatments are helping, and he has feeling back in his arms, legs and is walking around with a walker and doing the therapy to strengthen his leg muscles. They said that they would evaluate him and see if he needed to stay longer or if he needs to go to another facility.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: Guillain-Barre syndrome, Magnetic resonance imaging head, Muscular weakness, Plasmapheresis, Sensory loss
Clinical narrative: Guillain-Barre Syndrome; Vaccination Site Pain/a small pain where he got the vaccine; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2730830-1 (VAERS ID).  A 67-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Nov2023 as dose 1, single (Lot number: 10L752F) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; METFORMIN HCL; GLIPIZIDE; OLMESARTAN MEDOXOMIL; LEVOTHYROXINE. The patient also took other concomitant therapy. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "Vaccination Site Pain/a small pain where he got the vaccine"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset 06Dec2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: Dec2023, discharge date: 29Dec2023, hospitalization duration: 17 day(s)). Patient got his vaccine, had a small pain where he got the vaccine, no AE until he started loosing the sensation in his legs. He called his doctor, that he thought it was a sciatic nerve. They felt it was something more serious. His neighbor is a neurosurgeon, who directed him to another hospital ER. In that ER (hospital) he had MRI of brain, spinal tap and they determined that he had Guillain Barre as his enzymes and protein in the spinal fluid was 400 where it should be 40. He was hospitalized for 17 days. It affected him where he could not have a bowel movement for 9 days, and now that has resolved with the plasma exchange. He had 7 treatment of plasmapheresis, and was discharged on 29Dec23 to a rehab center since 29Dec2023 and is supposed to be there until 20Jan2024 where he will be able to go home. The treatments are helping, and he has feeling back in his arms, legs and is walking around with a walker and doing the therapy to strengthen his leg muscles. They said that they would evaluate him and see if he needed to stay longer or if he needs to go to another facility.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: Vaccination site pain, Walking aid user
Clinical narrative: Guillain-Barre Syndrome; Vaccination Site Pain/a small pain where he got the vaccine; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2730830-1 (VAERS ID).  A 67-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Nov2023 as dose 1, single (Lot number: 10L752F) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; METFORMIN HCL; GLIPIZIDE; OLMESARTAN MEDOXOMIL; LEVOTHYROXINE. The patient also took other concomitant therapy. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "Vaccination Site Pain/a small pain where he got the vaccine"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset 06Dec2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: Dec2023, discharge date: 29Dec2023, hospitalization duration: 17 day(s)). Patient got his vaccine, had a small pain where he got the vaccine, no AE until he started loosing the sensation in his legs. He called his doctor, that he thought it was a sciatic nerve. They felt it was something more serious. His neighbor is a neurosurgeon, who directed him to another hospital ER. In that ER (hospital) he had MRI of brain, spinal tap and they determined that he had Guillain Barre as his enzymes and protein in the spinal fluid was 400 where it should be 40. He was hospitalized for 17 days. It affected him where he could not have a bowel movement for 9 days, and now that has resolved with the plasma exchange. He had 7 treatment of plasmapheresis, and was discharged on 29Dec23 to a rehab center since 29Dec2023 and is supposed to be there until 20Jan2024 where he will be able to go home. The treatments are helping, and he has feeling back in his arms, legs and is walking around with a walker and doing the therapy to strengthen his leg muscles. They said that they would evaluate him and see if he needed to stay longer or if he needs to go to another facility.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: CSF protein increased, CSF test abnormal, Constipation, Enzyme level increased, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome; Vaccination Site Pain/a small pain where he got the vaccine; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2730830-1 (VAERS ID).  A 67-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Nov2023 as dose 1, single (Lot number: 10L752F) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; METFORMIN HCL; GLIPIZIDE; OLMESARTAN MEDOXOMIL; LEVOTHYROXINE. The patient also took other concomitant therapy. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "Vaccination Site Pain/a small pain where he got the vaccine"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset 06Dec2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: Dec2023, discharge date: 29Dec2023, hospitalization duration: 17 day(s)). Patient got his vaccine, had a small pain where he got the vaccine, no AE until he started loosing the sensation in his legs. He called his doctor, that he thought it was a sciatic nerve. They felt it was something more serious. His neighbor is a neurosurgeon, who directed him to another hospital ER. In that ER (hospital) he had MRI of brain, spinal tap and they determined that he had Guillain Barre as his enzymes and protein in the spinal fluid was 400 where it should be 40. He was hospitalized for 17 days. It affected him where he could not have a bowel movement for 9 days, and now that has resolved with the plasma exchange. He had 7 treatment of plasmapheresis, and was discharged on 29Dec23 to a rehab center since 29Dec2023 and is supposed to be there until 20Jan2024 where he will be able to go home. The treatments are helping, and he has feeling back in his arms, legs and is walking around with a walker and doing the therapy to strengthen his leg muscles. They said that they would evaluate him and see if he needed to stay longer or if he needs to go to another facility.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: Magnetic resonance imaging head, Muscular weakness, Plasmapheresis, Sensory loss, Vaccination site pain
Clinical narrative: Guillain-Barre Syndrome; Vaccination Site Pain/a small pain where he got the vaccine; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2730830-1 (VAERS ID).  A 67-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Nov2023 as dose 1, single (Lot number: 10L752F) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; METFORMIN HCL; GLIPIZIDE; OLMESARTAN MEDOXOMIL; LEVOTHYROXINE. The patient also took other concomitant therapy. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "Vaccination Site Pain/a small pain where he got the vaccine"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset 06Dec2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: Dec2023, discharge date: 29Dec2023, hospitalization duration: 17 day(s)). Patient got his vaccine, had a small pain where he got the vaccine, no AE until he started loosing the sensation in his legs. He called his doctor, that he thought it was a sciatic nerve. They felt it was something more serious. His neighbor is a neurosurgeon, who directed him to another hospital ER. In that ER (hospital) he had MRI of brain, spinal tap and they determined that he had Guillain Barre as his enzymes and protein in the spinal fluid was 400 where it should be 40. He was hospitalized for 17 days. It affected him where he could not have a bowel movement for 9 days, and now that has resolved with the plasma exchange. He had 7 treatment of plasmapheresis, and was discharged on 29Dec23 to a rehab center since 29Dec2023 and is supposed to be there until 20Jan2024 where he will be able to go home. The treatments are helping, and he has feeling back in his arms, legs and is walking around with a walker and doing the therapy to strengthen his leg muscles. They said that they would evaluate him and see if he needed to stay longer or if he needs to go to another facility.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: Walking aid user
Clinical narrative: Guillain-Barre Syndrome; Vaccination Site Pain/a small pain where he got the vaccine; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2730830-1 (VAERS ID).  A 67-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Nov2023 as dose 1, single (Lot number: 10L752F) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; METFORMIN HCL; GLIPIZIDE; OLMESARTAN MEDOXOMIL; LEVOTHYROXINE. The patient also took other concomitant therapy. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "unknown", described as "Vaccination Site Pain/a small pain where he got the vaccine"; GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset 06Dec2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: Dec2023, discharge date: 29Dec2023, hospitalization duration: 17 day(s)). Patient got his vaccine, had a small pain where he got the vaccine, no AE until he started loosing the sensation in his legs. He called his doctor, that he thought it was a sciatic nerve. They felt it was something more serious. His neighbor is a neurosurgeon, who directed him to another hospital ER. In that ER (hospital) he had MRI of brain, spinal tap and they determined that he had Guillain Barre as his enzymes and protein in the spinal fluid was 400 where it should be 40. He was hospitalized for 17 days. It affected him where he could not have a bowel movement for 9 days, and now that has resolved with the plasma exchange. He had 7 treatment of plasmapheresis, and was discharged on 29Dec23 to a rehab center since 29Dec2023 and is supposed to be there until 20Jan2024 where he will be able to go home. The treatments are helping, and he has feeling back in his arms, legs and is walking around with a walker and doing the therapy to strengthen his leg muscles. They said that they would evaluate him and see if he needed to stay longer or if he needs to go to another facility.  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: small blisters on hands/ wrists and ankles/feet; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE (ongoing); CARVEDILOL (ongoing); TRAZODONE (ongoing); PARNATE (ongoing). The following information was reported: BLISTER (non-serious) with onset 07Mar2021, outcome "not recovered", described as "small blisters on hands/ wrists and ankles/feet". Therapeutic measures were not taken as a result of blister.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400017819 same patient/product, different dose number/event;US-PFIZER INC-202400007619 same patient/product, different dose number/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister
Clinical narrative: small blisters on hands/ wrists and ankles/feet; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMOTRIGINE (ongoing); CARVEDILOL (ongoing); TRAZODONE (ongoing); PARNATE (ongoing). The following information was reported: BLISTER (non-serious) with onset 07Mar2021, outcome "not recovered", described as "small blisters on hands/ wrists and ankles/feet". Therapeutic measures were not taken as a result of blister.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400017819 same patient/product, different dose number/event;US-PFIZER INC-202400007619 same patient/product, different dose number/event;
Sex: M
Vaccine: RSV, RSV
Symptoms: Acute respiratory failure, Asthenia, Cough, Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: muscular weakness/leg weakness; guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis); acute respiratory failure; viral upper respiratory tract infection; asthenia; cough; pyrexia; respiratory tract congestion; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2738290-1 (VAERS ID).  A 73-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2024 as dose 1, single (Lot number: 9J7TT) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM2" (unspecified if ongoing); "ILD" (unspecified if ongoing); "COVID", start date: 2021 (unspecified if ongoing); "Hypelipidemia" (unspecified if ongoing); "strokes" (unspecified if ongoing), notes: Hx Of prior strokes; "smoking", stop date: 2013, notes: quit 11 years ago; "erectile dysfunction" (unspecified if ongoing); "mild cough" (unspecified if ongoing). Concomitant medication(s) included: ASA oral; ATORVASTATIN oral; LISINOPRIL oral; AZELASTINE nasal; RHINOCORT AQUA nasal; TADALAFIL oral. The patient also took other concomitant therapy. The following information was reported: VIRAL UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 06Jan2024, outcome "recovered" (Jan2024); MUSCULAR WEAKNESS (hospitalization) with onset 12Jan2024, outcome "recovered" (Jan2024), described as "muscular weakness/leg weakness"; ACUTE RESPIRATORY FAILURE (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024); ASTHENIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); COUGH (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); PYREXIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024), described as "guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis)", RESPIRTAORY TRACT CONGESTION (non-serious) with onset Jan2024, outcome "recovered" (Jan2024). Patient had a very mild cough on the day of vaccination. However, started to have cough, chest congestion, fevers starting 06Jan2024 consistent with a viral URI. Testing was negative upon admission 13Jan2024. Patient was admitted to the hospital 13Jan2024 with leg weakness that started on 12Jan2024. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 16Jan2024. Underwent lumbar puncture 14Jan2024 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GaS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 14Jan2024) and IVIG (2 doses daily, starting 14Jan2024). Improved with supportive care, extubated 20Jan2024. Being discharged to acute rehab on 14Jan2024.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Laboratory test normal, Lumbar puncture normal, Muscular weakness, Plasmapheresis
Clinical narrative: muscular weakness/leg weakness; guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis); acute respiratory failure; viral upper respiratory tract infection; asthenia; cough; pyrexia; respiratory tract congestion; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2738290-1 (VAERS ID).  A 73-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2024 as dose 1, single (Lot number: 9J7TT) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM2" (unspecified if ongoing); "ILD" (unspecified if ongoing); "COVID", start date: 2021 (unspecified if ongoing); "Hypelipidemia" (unspecified if ongoing); "strokes" (unspecified if ongoing), notes: Hx Of prior strokes; "smoking", stop date: 2013, notes: quit 11 years ago; "erectile dysfunction" (unspecified if ongoing); "mild cough" (unspecified if ongoing). Concomitant medication(s) included: ASA oral; ATORVASTATIN oral; LISINOPRIL oral; AZELASTINE nasal; RHINOCORT AQUA nasal; TADALAFIL oral. The patient also took other concomitant therapy. The following information was reported: VIRAL UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 06Jan2024, outcome "recovered" (Jan2024); MUSCULAR WEAKNESS (hospitalization) with onset 12Jan2024, outcome "recovered" (Jan2024), described as "muscular weakness/leg weakness"; ACUTE RESPIRATORY FAILURE (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024); ASTHENIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); COUGH (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); PYREXIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024), described as "guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis)", RESPIRTAORY TRACT CONGESTION (non-serious) with onset Jan2024, outcome "recovered" (Jan2024). Patient had a very mild cough on the day of vaccination. However, started to have cough, chest congestion, fevers starting 06Jan2024 consistent with a viral URI. Testing was negative upon admission 13Jan2024. Patient was admitted to the hospital 13Jan2024 with leg weakness that started on 12Jan2024. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 16Jan2024. Underwent lumbar puncture 14Jan2024 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GaS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 14Jan2024) and IVIG (2 doses daily, starting 14Jan2024). Improved with supportive care, extubated 20Jan2024. Being discharged to acute rehab on 14Jan2024.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: Pyrexia, Respiratory tract congestion, Viral upper respiratory tract infection
Clinical narrative: muscular weakness/leg weakness; guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis); acute respiratory failure; viral upper respiratory tract infection; asthenia; cough; pyrexia; respiratory tract congestion; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2738290-1 (VAERS ID).  A 73-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2024 as dose 1, single (Lot number: 9J7TT) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM2" (unspecified if ongoing); "ILD" (unspecified if ongoing); "COVID", start date: 2021 (unspecified if ongoing); "Hypelipidemia" (unspecified if ongoing); "strokes" (unspecified if ongoing), notes: Hx Of prior strokes; "smoking", stop date: 2013, notes: quit 11 years ago; "erectile dysfunction" (unspecified if ongoing); "mild cough" (unspecified if ongoing). Concomitant medication(s) included: ASA oral; ATORVASTATIN oral; LISINOPRIL oral; AZELASTINE nasal; RHINOCORT AQUA nasal; TADALAFIL oral. The patient also took other concomitant therapy. The following information was reported: VIRAL UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 06Jan2024, outcome "recovered" (Jan2024); MUSCULAR WEAKNESS (hospitalization) with onset 12Jan2024, outcome "recovered" (Jan2024), described as "muscular weakness/leg weakness"; ACUTE RESPIRATORY FAILURE (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024); ASTHENIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); COUGH (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); PYREXIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024), described as "guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis)", RESPIRTAORY TRACT CONGESTION (non-serious) with onset Jan2024, outcome "recovered" (Jan2024). Patient had a very mild cough on the day of vaccination. However, started to have cough, chest congestion, fevers starting 06Jan2024 consistent with a viral URI. Testing was negative upon admission 13Jan2024. Patient was admitted to the hospital 13Jan2024 with leg weakness that started on 12Jan2024. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 16Jan2024. Underwent lumbar puncture 14Jan2024 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GaS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 14Jan2024) and IVIG (2 doses daily, starting 14Jan2024). Improved with supportive care, extubated 20Jan2024. Being discharged to acute rehab on 14Jan2024.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: Immunoglobulin therapy, Lumbar puncture normal, Muscular weakness, Plasmapheresis, Pyrexia
Clinical narrative: muscular weakness/leg weakness; guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis); acute respiratory failure; viral upper respiratory tract infection; asthenia; cough; pyrexia; respiratory tract congestion; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2738290-1 (VAERS ID).  A 73-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2024 as dose 1, single (Lot number: 9J7TT) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM2" (unspecified if ongoing); "ILD" (unspecified if ongoing); "COVID", start date: 2021 (unspecified if ongoing); "Hypelipidemia" (unspecified if ongoing); "strokes" (unspecified if ongoing), notes: Hx Of prior strokes; "smoking", stop date: 2013, notes: quit 11 years ago; "erectile dysfunction" (unspecified if ongoing); "mild cough" (unspecified if ongoing). Concomitant medication(s) included: ASA oral; ATORVASTATIN oral; LISINOPRIL oral; AZELASTINE nasal; RHINOCORT AQUA nasal; TADALAFIL oral. The patient also took other concomitant therapy. The following information was reported: VIRAL UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 06Jan2024, outcome "recovered" (Jan2024); MUSCULAR WEAKNESS (hospitalization) with onset 12Jan2024, outcome "recovered" (Jan2024), described as "muscular weakness/leg weakness"; ACUTE RESPIRATORY FAILURE (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024); ASTHENIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); COUGH (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); PYREXIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024), described as "guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis)", RESPIRTAORY TRACT CONGESTION (non-serious) with onset Jan2024, outcome "recovered" (Jan2024). Patient had a very mild cough on the day of vaccination. However, started to have cough, chest congestion, fevers starting 06Jan2024 consistent with a viral URI. Testing was negative upon admission 13Jan2024. Patient was admitted to the hospital 13Jan2024 with leg weakness that started on 12Jan2024. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 16Jan2024. Underwent lumbar puncture 14Jan2024 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GaS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 14Jan2024) and IVIG (2 doses daily, starting 14Jan2024). Improved with supportive care, extubated 20Jan2024. Being discharged to acute rehab on 14Jan2024.  No follow-up attempts are possible.
Sex: M
Vaccine: RSV, RSV
Symptoms: Respiratory tract congestion, Respiratory viral panel, Viral test negative, Viral upper respiratory tract infection
Clinical narrative: muscular weakness/leg weakness; guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis); acute respiratory failure; viral upper respiratory tract infection; asthenia; cough; pyrexia; respiratory tract congestion; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2738290-1 (VAERS ID).  A 73-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2024 as dose 1, single (Lot number: 9J7TT) intramuscular, in left arm for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM2" (unspecified if ongoing); "ILD" (unspecified if ongoing); "COVID", start date: 2021 (unspecified if ongoing); "Hypelipidemia" (unspecified if ongoing); "strokes" (unspecified if ongoing), notes: Hx Of prior strokes; "smoking", stop date: 2013, notes: quit 11 years ago; "erectile dysfunction" (unspecified if ongoing); "mild cough" (unspecified if ongoing). Concomitant medication(s) included: ASA oral; ATORVASTATIN oral; LISINOPRIL oral; AZELASTINE nasal; RHINOCORT AQUA nasal; TADALAFIL oral. The patient also took other concomitant therapy. The following information was reported: VIRAL UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 06Jan2024, outcome "recovered" (Jan2024); MUSCULAR WEAKNESS (hospitalization) with onset 12Jan2024, outcome "recovered" (Jan2024), described as "muscular weakness/leg weakness"; ACUTE RESPIRATORY FAILURE (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024); ASTHENIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); COUGH (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); PYREXIA (non-serious) with onset Jan2024, outcome "recovered" (Jan2024); GUILLAIN-BARRE SYNDROME (hospitalization, disability, medically significant, life threatening) with onset Jan2024, outcome "recovered" (Jan2024), described as "guillain-barre syndrome/AIDP (acute inflammatory demyelinating polyneuritis)", RESPIRTAORY TRACT CONGESTION (non-serious) with onset Jan2024, outcome "recovered" (Jan2024). Patient had a very mild cough on the day of vaccination. However, started to have cough, chest congestion, fevers starting 06Jan2024 consistent with a viral URI. Testing was negative upon admission 13Jan2024. Patient was admitted to the hospital 13Jan2024 with leg weakness that started on 12Jan2024. This rapidly progressed to ascending weakness that progressed to acute respiratory failure; was intubated 16Jan2024. Underwent lumbar puncture 14Jan2024 that was negative. Was diagnosed with AIDP (acute inflammatory demyelinating polyneuritis)/GaS (Guillan Barre Syndrome) and started on plasmapheresis (underwent 8 sessions, starting 14Jan2024) and IVIG (2 doses daily, starting 14Jan2024). Improved with supportive care, extubated 20Jan2024. Being discharged to acute rehab on 14Jan2024.  No follow-up attempts are possible.