chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Limb discomfort, Muscle spasms, Muscular weakness, Pain, Pain in extremity
Clinical narrative: Leg cramping nighttime then leg pain while walking or sitting and occasional leg buckling.  Since Monday 12/23 /2024 feeling leg heaviness and general pain
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received subsequent dose of RSV Arexvy. Received first dose on 11/3/2023 and subsequent dose on 11/12/2024.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discolouration, Injection site erythema, Injection site haemorrhage
Clinical narrative: When removed the bandage I noticed it was saturated with blood, which is uncommon for me when I get a shot.  Shortly thereafter I noticed a brownish red spot with 'bruising' discoloration around it which is still changing colors.  It started out dark red, then dark green, then light green and now it is bright yellow with tan undertones.  It does not hurt, but I do not understand why I have this.  There was no pain when the shot was administered.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Urticaria that started shortly after my last (#6) COVID booster vaccine. I was treated on 11/4/24 with steroids pack and triamcinolone cream via a telehealth visit. The rash did clear up but has returned a week after completing the treatment and is now moving around on my body ( abdomen-thighs-arms) . In the last couple days I'm starting to develop angioedema on the area of the current rash.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid infection with hospitalization after vaccination
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, UNK
Symptoms: Cough, Headache, Oropharyngeal pain, Respiratory pathogen panel, Rhinorrhoea
Clinical narrative: Cough, runny nose, sore throat, headache
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Nine days after the flu vaccination I developed hives.  The hive started on my upper legs, then spread to my torso, arms and neck.  I went to clinic.  The doctor prescribed Prednisone.  the itching is lessening.  The hives look the same.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms, headache, coughing, shortness of breath, congestion, generalized body aches
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory pathogen panel, Respiratory tract congestion
Clinical narrative: Flu-like symptoms, headache, coughing, shortness of breath, congestion, generalized body aches
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC20, RV5
Symptoms: Blood culture, Chapped lips, Chest X-ray, Coronary artery aneurysm, Coronary artery dilatation
Clinical narrative: Patient developed a fever 1-2 days after vaccines and then fussiness.   Seen in clinic on 12/9 and sent to ED for eval due to fussiness,  Noted also to have red eyes, dry cracked lips, and enlarged lymph node.  Kept for evaluation x 24 hours but discharged due to no more fever.   Seen again in clinic on 12/13 and no fevers.  Developed new fevers 12/16 and started on antibiotics for possible lymph adenitis. Fevers higher on 12/19 and repeat labs with increased inflammation, elevated liver enzymes so sent back to ED.  Admitted and treated for kawasaki disease with coronary artery aneurysms and dilation on echo.  Pt treated with IVIG, aspirin, steroids, plavix.  Seen by ID team and cardiology as well as ENT
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC20, RV5
Symptoms: Echocardiogram abnormal, Full blood count, Hepatic enzyme increased, Immunoglobulin therapy, Inflammation
Clinical narrative: Patient developed a fever 1-2 days after vaccines and then fussiness.   Seen in clinic on 12/9 and sent to ED for eval due to fussiness,  Noted also to have red eyes, dry cracked lips, and enlarged lymph node.  Kept for evaluation x 24 hours but discharged due to no more fever.   Seen again in clinic on 12/13 and no fevers.  Developed new fevers 12/16 and started on antibiotics for possible lymph adenitis. Fevers higher on 12/19 and repeat labs with increased inflammation, elevated liver enzymes so sent back to ED.  Admitted and treated for kawasaki disease with coronary artery aneurysms and dilation on echo.  Pt treated with IVIG, aspirin, steroids, plavix.  Seen by ID team and cardiology as well as ENT
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC20, RV5
Symptoms: Irritability, Kawasaki's disease, Lip dry, Lymphadenopathy, Metabolic function test
Clinical narrative: Patient developed a fever 1-2 days after vaccines and then fussiness.   Seen in clinic on 12/9 and sent to ED for eval due to fussiness,  Noted also to have red eyes, dry cracked lips, and enlarged lymph node.  Kept for evaluation x 24 hours but discharged due to no more fever.   Seen again in clinic on 12/13 and no fevers.  Developed new fevers 12/16 and started on antibiotics for possible lymph adenitis. Fevers higher on 12/19 and repeat labs with increased inflammation, elevated liver enzymes so sent back to ED.  Admitted and treated for kawasaki disease with coronary artery aneurysms and dilation on echo.  Pt treated with IVIG, aspirin, steroids, plavix.  Seen by ID team and cardiology as well as ENT
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC20, RV5
Symptoms: Ocular hyperaemia, Pyrexia, Respiratory viral panel, Ultrasound neck, Urine analysis
Clinical narrative: Patient developed a fever 1-2 days after vaccines and then fussiness.   Seen in clinic on 12/9 and sent to ED for eval due to fussiness,  Noted also to have red eyes, dry cracked lips, and enlarged lymph node.  Kept for evaluation x 24 hours but discharged due to no more fever.   Seen again in clinic on 12/13 and no fevers.  Developed new fevers 12/16 and started on antibiotics for possible lymph adenitis. Fevers higher on 12/19 and repeat labs with increased inflammation, elevated liver enzymes so sent back to ED.  Admitted and treated for kawasaki disease with coronary artery aneurysms and dilation on echo.  Pt treated with IVIG, aspirin, steroids, plavix.  Seen by ID team and cardiology as well as ENT
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site discomfort, Injection site mass, Irritability
Clinical narrative: Patient's mother noticed today that there was a pea lump where the patient received a vaccine a week ago. Per mom when she was rubbing over the lump the baby seemed to experience discomfort by pulling leg away and getting fussy. Mom was informed to keep an eye on the lump and to call the clinic back on Monday to inform staff on how patient is doing.
Age: 80.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt experienced redness, swelling and itching at the injection site. The symptoms began several hours post-vaccination.  Pt had some relief with topical anti-itch medication.  Pt recommended oral anti-histamine and cold/ hot compress for symptom relief.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash breakout
Age: 50.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Balance disorder, Guillain-Barre syndrome, Laboratory test, Muscular weakness, Pain in extremity
Clinical narrative: Patient reports that she started to have some aches from her hands to elbows Wednesday 11/13/2024, Thursday 11/14/2024 she woke up and started to have some lower extremity bilateral weakness and wobbly upon ambulation to the restroom. Patient reports that she contacted her physician and scheduled an appointment for Friday morning. Friday 11/15/2024 upon waking her symptoms worsened and her husband took her right to the emergency room. Patient was admitted on 11/15/2024 and then discharged to inpatient rehab on 12/09/2024. Patient is still currently inpatient rehab as of 12/26/2024. Patient reports that the physicians believe she may also have AIDP along with GBS. Patient reported that she is continuing to have additional testing related to the GBS and AIDP. Patient reported that she had historically received influenza vaccination without any problems. Patient also reported that last year she received both influenza and COVID vaccination without concerns.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Cough, Nausea
Clinical narrative: Terrible congestion  head and chest  cough  nausea  chills weakness over 2 weeks
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Terrible congestion  head and chest  cough  nausea  chills weakness over 2 weeks
Age: 59.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Injection site erythema, Joint swelling
Clinical narrative: Patient presented to clinic 12/23/24 at 10:37 with complaints of a swollen and red left upper arm and chills. Oral temp 98.3.  Black line approx 2.5 inches long noted on upper left arm; EE states she had drawn line measuring redness this morning and that redness has grown since then. Redness has grown beyond marked area per visualization. Redness and swelling only noted today, per Patient. Patient requesting to be evaluated. RN sent information regarding referral to Clinic to the EE and their supervisor along with injured workers handout. RN advised EE to contact RN with any questions or concerns and EE verbalized understanding. --RN.  EE was seen at Occ Med on 12/23/24 per Dr. The following is an excerpt from the provider's notes: DISCUSSION At this point it is my opinion that the patient is having significant local reaction to her immunizations. I am unconvinced that she has a superimposed infection or abscess. For now I will recommend cold compresses. Continue ibuprofen as tolerated. Recommend Benadryl for the itching. Will recheck here in 3 days. Contact us sooner if symptoms worsen. Discussed with staff at Hospital. No work restrictions. RECOMMENDED WORK STATUS Patient's recommended work status is Regular Duty. The effective date for this work status is 12/23/2024.
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted briefly after receiving the 2 vaccines, but regained consciousness in a few seconds. No breathing problems nor any other complaints after she regained consciousness. Patient remain seated in a chair for 30 minutes for monitoring and proceeded to walk out of the store afterwards normally.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: IPOL dose administered on 9/11/2024 was found not to be stored correctly.  The stability of punctured MDS outside of the recommended storage conditions has not been evaluated. Sanofi does not have specific guidance regarding revaccination or re administration. Advising to contact local health department.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: There were no adverse events, no additional treatments or outcomes. The patient was given a smaller dose than what her age requires.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: IPOL dose administered on 9/11/2024 was found not to be stored correctly. The stability of punctured MDS outside of the recommended storage conditions has not been evaluated. Sanofi does not have specific guidance regarding revaccination or re administration. Advising to contact local health department for guidance.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: IPOL dose administered on 10/23/2024 was found not to be stored correctly.  The stability of punctured MDS outside of the recommended storage conditions has not been evaluated. Sanofi does not have specific guidance regarding revaccination or re administration. Advising to contact local health department. Ipol dose administered on 10/23/2024 was found not to be warranted. Patient completed series in 2015.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Pain, Pyrexia, Tachycardia
Clinical narrative: Pt received vaccination and presented to ED approximately 10 hours later with body aches, fever, chills, SOB, and tachycardia
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Echocardiogram, Electrocardiogram, Fibrin D dimer increased
Clinical narrative: None stated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pericardial effusion, Platelet count decreased, Ultrasound Doppler abnormal
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Norovirus infection
Clinical narrative: I have Norovirus. This is not vax related.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Patient briefly lost consciousness and showed signs of convulsions. Episode lasted for approximately 15 seconds. Patient was asked to lie down and was given water to drink. We requested that the patient remain seated within the pharmacy for 15 minutes following the event for monitoring.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Stroke. Admitted 8/6/22-8/10/22.  Attending Physician.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Blood test, Headache, Henoch-Schonlein purpura, Nasopharyngeal swab, Pyrexia
Clinical narrative: A couple hours after receiving vaccine...giants hives all over left arm, severe headache, high fever..symptoms got worse everyday. By day 5, ened up in ER with horrible rash all over legs. After hours of drawing blood, swabbing nostrils and throat and antibiotic shot in butt...a nephrologist diag used him with hsp/iga vasculitis informing us that his body immune system attacked itself instead of the vaccine causing kidney damage. We've done renal ultrasound and urine analysis every week for 6months to a year to monitor kidneys. Absolutely, devastated. My son walked in completely healthy on Oct 8th and will never be the same
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Rash, Renal injury, Ultrasound kidney, Urine analysis, Urticaria
Clinical narrative: A couple hours after receiving vaccine...giants hives all over left arm, severe headache, high fever..symptoms got worse everyday. By day 5, ened up in ER with horrible rash all over legs. After hours of drawing blood, swabbing nostrils and throat and antibiotic shot in butt...a nephrologist diag used him with hsp/iga vasculitis informing us that his body immune system attacked itself instead of the vaccine causing kidney damage. We've done renal ultrasound and urine analysis every week for 6months to a year to monitor kidneys. Absolutely, devastated. My son walked in completely healthy on Oct 8th and will never be the same
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blood test, CSF test, Electrocardiogram, Electroencephalogram, Encephalitis
Clinical narrative: My son started to have seizures and was eventually diagnosed with MOGAD/FLAAMES.  He had three seizures starting on 07/25, was hospitalized for two weeks until he was given a steroid treatment for encephalitis.  He then relapsed late November and had another round of steroids.  We are going to start with IVIG treatments soon.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Magnetic resonance imaging, Myelin oligodendrocyte glycoprotein antibody-associated disease, Scan with contrast, Seizure
Clinical narrative: My son started to have seizures and was eventually diagnosed with MOGAD/FLAAMES.  He had three seizures starting on 07/25, was hospitalized for two weeks until he was given a steroid treatment for encephalitis.  He then relapsed late November and had another round of steroids.  We are going to start with IVIG treatments soon.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, C-reactive protein increased, Gait disturbance, Loss of personal independence in daily activities, Pain
Clinical narrative: By the third day my wrists, elbows, shoulders, hips, knees, ankles and feet all hurt.  I could barely walk. My husband had to dress me. I had to pick my leg up to get in the car and on the curb at the urgent care I went to. I hurt all over and could barely move. Because of the RA dx, anytime I have any kind of joint pain I try to think what I have done, eaten, or taken differently. I immediately thought about the vaccine and started thinking back to when it all began.  My symptoms were always worse in the Fall, which would be after the vaccine.  When COVID hit I had to vaccines and a booster and the symptoms were worse during that time. I had blood work done a couple of days after the vaccine and my C-Reactive Proteins were extremely elevated. The clinic doctor told me I had Serum Sickness and she wanted to monitor me for a week to ensure it wasn't GBS and told me to go to the ER if I started having trouble breathing.  I was given a steroid injection and a dose pack. I felt better within 2 days and that continued until the dose pack ran out. I have had the same symptoms ever since, some days worse than others, but they have never gone away.  I have spoken with 3 doctors since this happened and all of them have advised me against every taking another vaccine because whatever it is in them that I am reacting to can get worse with each dose. I will never take another one.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Serum sickness
Clinical narrative: By the third day my wrists, elbows, shoulders, hips, knees, ankles and feet all hurt.  I could barely walk. My husband had to dress me. I had to pick my leg up to get in the car and on the curb at the urgent care I went to. I hurt all over and could barely move. Because of the RA dx, anytime I have any kind of joint pain I try to think what I have done, eaten, or taken differently. I immediately thought about the vaccine and started thinking back to when it all began.  My symptoms were always worse in the Fall, which would be after the vaccine.  When COVID hit I had to vaccines and a booster and the symptoms were worse during that time. I had blood work done a couple of days after the vaccine and my C-Reactive Proteins were extremely elevated. The clinic doctor told me I had Serum Sickness and she wanted to monitor me for a week to ensure it wasn't GBS and told me to go to the ER if I started having trouble breathing.  I was given a steroid injection and a dose pack. I felt better within 2 days and that continued until the dose pack ran out. I have had the same symptoms ever since, some days worse than others, but they have never gone away.  I have spoken with 3 doctors since this happened and all of them have advised me against every taking another vaccine because whatever it is in them that I am reacting to can get worse with each dose. I will never take another one.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong patient
Clinical narrative: With both sisters in room, the nurse admin the younger sister the MenB dose meant for the older sister. The client was notified along with her grandmother who was still in the exam room. The client waited 15 minutes in lobby, said she felt fine and they left.  The legal mother was also notified. Questions answered
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Rash
Clinical narrative: Hard pain from my spine to belly button on the left side in the evening of the 17th, I thought it was my back. The shingles rash appeared 3 days later, the evening of the 19th. I went to urgent care the next morning, the 20th and was prescribed Gabapentin and a 4 pill anti-viral. It was diagnosed as shingles. I am still broke out, I am taking Gabapintin and I buprofen.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Mycobacterium tuberculosis complex test negative
Clinical narrative: Patient came to office 12/18/2024 for Covid-19 Booster Vaccination (patient previously had reported Covid-19 Pfizer vaccinations on: 5/27/2021 and 6/27/2021; with no reactions noted).  Patient was asymptomatic at date of service.  12/26/2024 @1130 Per RN, patient reported to office with complaint of shortness of breath/difficulty breathing since he had the covid vaccine on 12/18/2024.  Patient spoke with front desk who advised him to see a doctor right away.  Spoke with patient who states he is entering Urgent Care for evaluation per our office.  Spoke with Urgent Care who confirms patient is waiting for provider to evaluate.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Cold sweat, Fall, Hypotonia, Loss of consciousness
Clinical narrative: Patient became cold and clamy before losing consciousness. His arm did stiffen and then go flaccid before falling back and fainting to floor. He did collapse from  chair and fall onto carpeted ground in vaccination room. He was out of consciousness for approximately 10 seconds before waking up . He did ask what happened and we told him. He asked for a bag to vomit in and we provided him with one. He was not given any foods or liquids post syncope. He asked for a ice pack to place under his neck and we provided him with one. EMS was called and we stayed on the phone with them until help arrived. He was alert and talking to us the entire time. EMS did transfer patient to the hospital .
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient recieved TDAP in place of DTAP. No adverse reactions. No treatment needed. Family notified.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt was given a Fluzone HD vaccination in error instead of the requested Tdap vaccination.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: The day following the vaccine, the patient's arm developed swelling and was red and hot.  She had fatigue, Headache and nausea along with stiff muscles and joint pain.  The doctor measured the rash to be 5.5cm x 4.4cm.  The symptoms began improving on day 3 and after one week they have almost all resolved.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Nausea, Peripheral swelling, Rash, Skin warm
Clinical narrative: The day following the vaccine, the patient's arm developed swelling and was red and hot.  She had fatigue, Headache and nausea along with stiff muscles and joint pain.  The doctor measured the rash to be 5.5cm x 4.4cm.  The symptoms began improving on day 3 and after one week they have almost all resolved.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Muscular weakness, Ocular discomfort, Sacral pain
Clinical narrative: Muscle weakness, couldn't walk, pain in sacro, eye pressure
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: she remembers a patient passing out after receiving GARDASIL 9; This spontaneous report has been received from a medical assistant regarding an 11-year-old male. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not provided).  On an unknown date, the patient experienced passing out after receiving the vaccine (Loss of consciousness). The outcome of the event was not reported.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review, the event loss of consciousness was determined to be medically significant.; Sender's Comments:  US-009507513-2412USA002427:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: she had the pain at injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 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 injection site pain (Verbatim: she had the pain at injection site). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-NOV-2024 Pharmacist reported that he had a customer come and ask about a reaction after the Shingrix vaccine. She stated she had the pain at injection site for a few days as can be typical, but then she said it went away and then 3 weeks later she stated that the pain as back. She did not have a bruise, but wondered if it could be shot related. He tried to research this but have not found anything, so pharmacist coming to the source.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: headache; aches; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-NOV-2024, the patient received the 2nd dose of Shingrix. In NOV-2024, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache), pain (Verbatim: aches) and chills (Verbatim: chills). The outcome of the headache, pain and chills were not resolved.   It was unknown if the reporter considered the headache, pain and chills to be related to Shingrix.     It was unknown if the company considered the headache, pain and chills to be related to Shingrix.   Additional Information: GSK receipt date: 26-NOV-2024 The patient received second shot of Shingrix vaccine the day before reporting and experienced headache, aches, and chills. The reporter had a question could he/she took Advil for some of the symptoms he/she had experienced such as headache, aches, and chills. The patient had a question about only 1 product that was Shingrix vaccine. The patient had requested for medical advice/recommendation and the chat bot answer that the GlaxoSmithKline made medicines and vaccines that need a prescription they could not give medical advice. They suggested that it was important to talked with doctor or other healthcare provider for guidance based on medical history. The patient reported that he/she overall feeling good just did not want to counter-act the shot by taking Advil. The reporter reported that the nurse did not give him/her a document when he/she got his/her shot yesterday (day before reporting). No further information were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes, Pyrexia
Clinical narrative: cold sores on upper lip on the right side; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores lip in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cold sores and fever.   On 24-NOV-2024, the patient received Shingrix. On 24-NOV-2024, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever). On 26-NOV-2024, the patient experienced cold sores lip (Verbatim: cold sores on upper lip on the right side). The patient was treated with ibuprofen. In NOV-2024, the outcome of the fever was resolved. The outcome of the cold sores lip was not reported.   It was unknown if the reporter considered the cold sores lip and fever to be related to Shingrix.     It was unknown if the company considered the cold sores lip and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-NOV-2024 The patient had a history of cold sore with fevers. The reporter reported that received the Shingrix vaccine on Sunday, 24 Nov 2024 and that night got a fever of 101.8 and took ibuprofen, fever broke but this morning on 26 Nov 2024, woke up with cold sores on upper lip on the right side. The patient wanted to know if he/she can take either valtrex or abreva for the cold sores. The agent said patient have asked an important question which requires medical advice. Because patient care was individualized, a healthcare provider should always be consulted to evaluate health and provide guidance to patient based on medical history. As a pharmaceutical manufacturer, they do not provide medical advice or guidance.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain, Fatigue, Pain in extremity
Clinical narrative: arm soreness; fatigue; pain in opthalmic region; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient had Shingles in his/her 30s).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm soreness), fatigue (Verbatim: fatigue) and facial pain (Verbatim: pain in opthalmic region). The outcome of the pain in arm, fatigue and facial pain were not reported.   It was unknown if the reporter considered the pain in arm, fatigue and facial pain to be related to Shingrix.     It was unknown if the company considered the pain in arm, fatigue and facial pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-DEC-2024 Patient had shingles in my 30s and got vaccinated at the age of 51. After the first shot patient had a more robust reaction in terms of arm soreness and fatigue. Also developed return of a bit of pain in the ophthalmic region where his/her shingles attack happened.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pneumonia, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles 2x with pneumonia in between; shingles 2x with pneumonia in between; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), pneumonia (Verbatim: shingles 2x with pneumonia in between) (serious criteria GSK medically significant) and shingles (Verbatim: shingles 2x with pneumonia in between). The outcome of the vaccination failure was not reported and the outcome of the pneumonia and shingles were resolved.   It was unknown if the reporter considered the vaccination failure, pneumonia and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and pneumonia to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-DEC-2024 This case was reported by a patient via interactive digital media. Patient had shingles twice with pneumonia in between for a little over 6 months from one side then to another. A month ago, in NOV-2024 (from the date of reporting), the patient had the shooting pain on his/her right side again and that pain lasted for 2 weeks. And further patient stated that he/she had the shots. 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 regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine. Pneumonia  is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; pain from nerve ending; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: pain from nerve ending). The outcome of the vaccination failure, shingles and post herpetic neuralgia were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-DEC-2024  This case was reported by a patient via interactive digital media. The patient had received shingles shot. The patient got shingles and believed him/her that it was no fun and blisters were healed but the pain from nerve endings was horrible so would not want anyone to have shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 Shingles vaccine.
Sex: M
Vaccine: HEP, HEPAB, HEPAB, HEPAB
Symptoms: Hepatitis B antibody negative, Product prescribing error, Therapy non-responder
Clinical narrative: Came back titer negative for hepB; has prescribed a double-dose of HepB vaccine, clarified to be Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of hepatitis b antibody negative in a 72-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis, HAB (Twinrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included non-alcoholic steatohepatitis (NASH), hyperparathyroidism (primary), warthin's tumor, hypothyroidism, ventral hernia repair and hepatic cirrhosis.   On an unknown date, the patient received the 3rd dose of Twinrix. On 20-FEB-2023, the patient received the 2nd dose of Twinrix. On 18-JAN-2023, the patient received the 1st dose of Twinrix. On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Twinrix, Twinrix and Twinrix and not applicable after receiving Engerix B, the patient experienced hepatitis b antibody negative (Verbatim: Came back titer negative for hepB) and product prescribing error (Verbatim: has prescribed a double-dose of HepB vaccine, clarified to be Engerix-B). The outcome of the hepatitis b antibody negative and product prescribing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-NOV-2024 The nurse supervisor reported that a patient received Twinrix dose one and two, and dose three at an unknown exact date. After that his Hepatitis A titers were fine, but the Hepatitis B came back titer negative, which led to hepatitis B antibody negative. The patient's gastro-entero-hepatologist had prescribed a double-dose of Hepatitis B vaccine, clarified to be Engerix B, and to repeat the titer in 3 to 6 months, which led to product prescribing error.
Sex: F
Vaccine: HEPA, HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Havrix (received Havrix on 20-JAN-2022 with batch number KM72C and expiration date 18-JUN-2022) and Twinrix (received Twinrix on 08-JUL-2021 with batch number X239D and expiration date 07-AUG-2022).   On an unknown date, the patient did not receive the 2nd dose of Havrix and the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Havrix and Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 The pharmacist reported that 67 year old female patient received a dose of Twinrix and then received a dose of Havrix.  A colleague of the pharmacist told him/her that the next step would be to administer Engerix-B, but at the time of reporting, no additional vaccines were administered.  Till the time of reporting the patient did not receive 2nd dose of Twinrix and Havrix which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: HEP
Symptoms: Intercepted product prescribing error
Clinical narrative: administration of 2 20 mcg doses of Engerix-B being combined to form a 40 microgram dose, as prescribed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 68-year-old female patient who received HBV (Engerix B adult) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis.   Previously administered products included Engerix b adulto (received first dose on unknown date).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced intercepted drug prescribing error (Verbatim: administration of 2 20 mcg doses of Engerix-B being combined to form a 40 microgram dose, as prescribed). The outcome of the intercepted drug prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 The pharmacist reported that the patient was prescribed 2 20 mcg doses of Engerix-B being combined to form a 40 microgram dose to administer by their physician.  They did specify that the patient was to receive a heart transplant and that the doses had not been administered yet, which led to intercepted drug prescribing error.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Boostrix to a patient on November 26th 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5R7B2, expiry date 25-NOV-2024) for prophylaxis.   Previously administered products included Diphtheria-Tetanus-Pertussis vaccines (received 5 dose in past), Pediarix (received 3rd dose in 13-AUG-2012), Pediarix (received 2nd dose in 08-JUN-2012), Pediarix (received 1st dose in 09-APR-2012) and Kinrix (received a dose in 13-MAR-2017).   On 26-NOV-2024, the patient received the 1st dose of Boostrix. On 26-NOV-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Boostrix to a patient on November 26th 2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 The nurse explained that they administered an expired dose of Boostrix to a patient on 26th November 2024 which led to expired vaccine used. The patient did not receive any prior Boostrix doses, but they received 5 diphtheria tetanus pertussis vaccines in the past. The patient received 3 doses of Pediarix in 2012. The patient also received a dose of Kinrix on 13th March 2017. The vaccine administration facility was the same as primary reporter.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: suboptimal dose/ adult patient received a pediatric dose; adult patient received a pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 53-year-old male patient who received HBV (Engerix B pediatric) (batch number 47xp4, expiry date 16-JUL-2026) for prophylaxis.   On 26-NOV-2024, the patient received the 1st dose of Engerix B pediatric. On 26-NOV-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: suboptimal dose/ adult patient received a pediatric dose) and adult use of a child product (Verbatim: adult patient received a pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 The MA (medical assistant) reported that today (on the day of reporting) an adult patient received a pediatric dose of Engerix-B, which led to an underdose and adult use of a child product.
Sex: F
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: patient now has another prescription of bexsero; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a elderly female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy. Previously administered products included Bexsero (received at the hospital when getting the splenectomy already on an unknown date).   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted product prescribing error (Verbatim: patient now has another prescription of bexsero). The outcome of the intercepted product prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 Pharmacist reported that for the Bexsero vaccine they had a patient who was over the age of 25 wanting the vaccine but their system was limiting them and said it was not appropriate. So, reporter wanted to see if it was approved for any reason over the age of 25. Further second line agent reported that, a patient older than 70 years old with splenectomy. She received Bexsero at the hospital when getting the splenectomy already but now has another prescription for Bexsero, which led to an intercepted product prescribing error.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Underdose; 20 plus years old patient received the pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) (batch number 95BJ9, expiry date 25-JUL-2026) for prophylaxis.   On 26-NOV-2024, the patient received Engerix B pediatric. On 26-NOV-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: 20 plus years old patient received the pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-NOV-2024 The nurse called to inform that earlier that day, a patient that needed to receive the adult dosing of Engerix-B for 20 plus years old received the pediatric dose which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Pharyngeal erythema, Stomatitis, Tongue eruption
Clinical narrative: lesions are still present in her mouth; can barely eat and can't enjoy food; noticed a sore, red throat on one side; red throat on one side; Rash on tongue/a small pimple came up on her tongue; This non-serious case was reported by a consumer via call center representative and described the occurrence of tongue papule in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-NOV-2024, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). In NOV-2024, 4 days after receiving Shingrix, the patient experienced tongue papule (Verbatim: Rash on tongue/a small pimple came up on her tongue). On 26-NOV-2024, the patient experienced sore throat (Verbatim: noticed a sore, red throat on one side) and red throat (Verbatim: red throat on one side). On an unknown date, the patient experienced oral lesion (Verbatim: lesions are still present in her mouth) and decreased appetite (Verbatim: can barely eat and can't enjoy food). The patient was treated with prednisone and prednisone. The outcome of the tongue papule and oral lesion were not resolved and the outcome of the sore throat and red throat were unknown and the outcome of the decreased appetite was not reported.   The reporter considered the tongue papule to be probably related to Shingrix. It was unknown if the reporter considered the sore throat, red throat, oral lesion and decreased appetite to be related to Shingrix.     The company considered the tongue papule to be probably related to Shingrix. It was unknown if the company considered the sore throat, red throat, oral lesion and decreased appetite to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-NOV-2024, 06-DEC-2024, 11-DEC-2024 The patient self-reported this case. The patient received her 2nd dose of Shingrix and four days later, a small pimple came up on her tongue.  The following day it began to spread until it was all over her tongue.   The patient saw a substitute physician at her regular healthcare professional's (HCP) office who stated it was likely from the Shingrix .  She reported that today (on the reporting day) she had noticed a sore and red throat on one side. The patient was seen by a different doctor in the practice on 21st November 2024 The patient called again today to report that the lesions were still present in her mouth and she saw her HCP, who prescribed oral prednisone which did not helped the condition.  She saw her HCP again who prescribed prednisone in ointment form which did not improved the lesions either.  The patient stated that she can barely eat and cannot enjoy food. The patient stated that her doctor prescribed antibiotics for her side effects. The Vaccine Administration Facility was the same as Primary Reporter.