chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy prostate, Condition aggravated, Magnetic resonance imaging, Prostate cancer, Prostatic specific antigen increased
Clinical narrative: After five years of minimal cancer of prostate and normal psa results, within a few weeks of covid booster, my psa started climbing rapidly.  Within a couple of months I was re-diagnosed with aggressive prostate cancer.
Age: 59.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Product storage error
Clinical narrative: The Comirnaty COVID-19 vaccine administered to the patient had previously been subject to a temperature excursion in January 2025, when a different pharmacist in charge (PIC) was overseeing operations. The vial was removed from refrigeration and left at room temperature for one to two days due to its upcoming expiration date of March 29, 2025. It was later returned to refrigeration for potential return but was administered to a patient on March 3, 2025. Patient also received Shingrix along with Comirnaty.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody, Blood creatine phosphokinase, Blood iron, Blood magnesium, C-reactive protein
Clinical narrative: Muscle pain, over-the-counter anti-inflammatory medications like ibuprofen occasionally, Try the muscle and nerve support supplement samples provided to assess their benefit,  physical therapy, offered referral to ortho.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Differential white blood cell count, Full blood count, Myalgia, Red blood cell sedimentation rate, Serum ferritin
Clinical narrative: Muscle pain, over-the-counter anti-inflammatory medications like ibuprofen occasionally, Try the muscle and nerve support supplement samples provided to assess their benefit,  physical therapy, offered referral to ortho.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Vitamin B12
Clinical narrative: Muscle pain, over-the-counter anti-inflammatory medications like ibuprofen occasionally, Try the muscle and nerve support supplement samples provided to assess their benefit,  physical therapy, offered referral to ortho.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did not have an adverse effect- was just given the wrong covid vaccine. Needed 5-11 covid, was given 12+
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sjogren's syndrome
Clinical narrative: Generalized autoimmune inflammation exacerbation of Sjogrens Syndrome
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: Patient experienced no side effects but was given the Arexvy vaccine twice. The patient had already gotten the vaccine in November 2023 which is not in accordance with current vaccine guidelines.
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: Patient stated that the day after receiving Prevnar 20 her arm was swollen form her elbow to her shoulder.  She stated that it was warm to the touch, red and she could not lift it.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received a Covid vaccine for age range of 5 year- 11-year-old instead of the 6m-4-year concentration. The vaccine was diluted with 1.1 mL of 0.9% Sodium Chloride prior to injection. After discussing with manufacturer, it was determined that the correct dose was given based on the calculations. The vial contains 15.8 mg MRNA in 0.48 mL of liquid and was mixed with 1.1 mL of diluent, containing 3 mcg of MRNA in the 0.3 mL dose given to patient. Patient's family did not report any initial reactions.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Headache, Pain, Pain in extremity
Clinical narrative: mom called office 2/24/2025 that pt on the night of2/21 was complaining of body aches and leg pain, pt is middle of the night woke up complaining of headache. mom did covid test was negative states the pt was very weak for a few days and feels it is vaccine related
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: round redness around the injection site. was swollen a bit but is going down overtime.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: 6 days post vaccine administration (2/20/25) patient developed itchy rash on extremities including hands and feet. Trunk was clear of rash. Remained afebrile during this time. Itching controlled with cortisone OTC cream. S/S resolved 2/24/25. Parent spoke with PCP no visit. She advised that PCP suggested not receiving another dose of meningococcal vaccine.  Sibling received  vaccines on same date with the exception of meningococcal vaccine with no ill effects.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product preparation issue
Clinical narrative: Patient in clinic for 4 year wellness appt. Patient had Proquad and Quadracel vaccines ordered to be given. After vaccines given the nurse found vaccines were reconstituted incorrectly. Proquad vaccine was diluted with Quadracel vaccine and administered. Sterile Diluent was administered by itself to patient. Quadracel vaccine in clinic depending on stock (Private vs VFC) can be in pre-drawn syringe or vial. The pre-drawn syringe looks similar to sterile diluent that is to be used with Proquad reconstitution.  Mother was with patient for visit and was informed by CTL that this error had occurred and RN would be in touch with her regarding if vaccinations needed to be repeated, what signs/symptoms to look for, etc. Mother voiced understanding. Child had no signs/symptoms of local reaction after vaccination. Waited in office 15 minutes.  RN reached out to VFC coordinator to inquire about error and information regarding repeating. She reached out to the CDC help desk and per CDC both vaccinations will need to be repeated. The Proquad will need to wait to be repeated in 28 days. RN called and spoke with mother regarding this and explained the reasoning behind re-vaccination and a letter was written in regards to the error as mother was needing vaccinations for child to start preschool. Vaccine only appointment made for 28 days out for repeat vaccinations. Mother to call back before then with any further questions or concerns. Education was done with the nurse that administered and a new work flow for preparation of these vaccines was discussed to prevent this error in the future.
Age: 24.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, Tuberculin test
Clinical narrative: Polio was inadvertently given to the patient instead of a PPD skin test.  When the error was noticed, the patient was immediately contacted and asked to return to the clinic.  Patient was given the TB Skin test .  The patient was informed the polio was given in error.  The Health Center Manager was notified.  Nurse manager followed up with the CDC.  Spoke with customer service agent.  Polio considered an extra dose.  Nurse manager f/u with the patient to inform her of the error.  Pt was understanding.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Nausea
Clinical narrative: The patient shopped in store for 15-20 minutes and then a 20 minute drive home.  Approximately 3 to 4 hours after administration patient developed the following:  nausea, headache, arm pain, flu-like symptoms, everything in body hurt, body aches, feverish, chills, and sweating.  The patient took an Aspirin and went to bed early.  The patient did not have any reaction to the 1st dose.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: The patient shopped in store for 15-20 minutes and then a 20 minute drive home.  Approximately 3 to 4 hours after administration patient developed the following:  nausea, headache, arm pain, flu-like symptoms, everything in body hurt, body aches, feverish, chills, and sweating.  The patient took an Aspirin and went to bed early.  The patient did not have any reaction to the 1st dose.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Day of vaccine pt experienced headache and weakness. Over the weekend noticed redness and swelling to injection site.
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: administration errors, was given a second dose. first was in  2023
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Product preparation issue
Clinical narrative: The dilute was given for Hiberix without the vaccination being mixed in.  The Lot number for the Hiberix was 5JF75 EXP 7/14/2026.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: We had a 14 yo male patient that was behind on his vaccines establish care with us on 2-24-25. The parents signed the consent for this patient to receive 7 vaccines. Once the consent was signed the nurse left the exam room and prepared the vaccines. When she returned to the room with the vaccines the patient became very combative. He screamed, elbowed his dad in the face, smacked his mother in the face, and smacked the nurse's arm away from him with an exposed needle in her hand. The patient's agitation continued to escalate and the nurse instructed the parents to return with the patient at a later date/time and we would try again.  We placed all the vaccines in a basket and returned them to the refrigerator. We did not know if the patient would return that afternoon, we also didn't know if he would comply if he did return. In an effort not to waste vaccines we used 2 of the vaccines from the basket on another patient.  The patient did return that afternoon and the nurse replaced the vaccines that were removed from the patients basket. Unfortunately one of the vaccines was an additional MMR II vaccine instead of the vaccine that needed to be replaced. The patient was mistakenly given two MMR II vaccines instead of one. The nurse realized the mistake as she was documenting the vaccines in the NCIR. She immediately notified the parents and we monitored the patient in-office for an hour and a half. The nurse educated the parents on what side effects  and/or reverse reactions to watch for. The nurse continued to check on the patient throughout that evening, night, and the next day. The patient did not experience any reactions or adverse side effects. He will return in 28 days from 2-24-25 to get the vaccine that he was not given on 2-24-25.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Pruritus, Respiratory distress, Wheezing
Clinical narrative: At 0750am, patient received yellow fever in his left deltoid and not subcutaneous as indicated. Patient returned to the clinic around 0820 stating that his throat was " itchy and he felt like he wasn't breathing very well". The RN notified the Medical Officer on Duty to evaluate the patient who then took over the care of the patient. His VSS but upon assessment the patient was wheezing, and he was placed on supplemental oxygen and received a breathing treatment. EMS arrived shortly to take the patient to a local hospital to be evaluated further due to his respiratory distress.
Age: 10.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: MEDICATION OUT OF REFRIGERATOR RANGE FOR A PERIOD OF TIME
Age: 10.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: MEDICATION OUT OF REFRIGERATOR RANGE FOR A PERIOD OF TIME
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Flushing, Rash, Rash pruritic
Clinical narrative: flush cheeks, generalized pruritic rash
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase increased, Blood bicarbonate normal
Clinical narrative: Suspected distal acquired demyelinating symmetric neuropathy - Acute onset of weakness w/ walking and standing (stumbling) and neuropathic pain in distal upper extremities w/o a clear trigger. Exam notable for intact lower extremity reflexes, stumbling gait, 4/5 strength in distal bilateral upper and lower extremities.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Blood bilirubin normal, Blood chloride normal, Blood creatine phosphokinase normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Suspected distal acquired demyelinating symmetric neuropathy - Acute onset of weakness w/ walking and standing (stumbling) and neuropathic pain in distal upper extremities w/o a clear trigger. Exam notable for intact lower extremity reflexes, stumbling gait, 4/5 strength in distal bilateral upper and lower extremities.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Blood potassium normal, Blood sodium decreased, Blood urea normal, C-reactive protein increased, Demyelinating polyneuropathy
Clinical narrative: Suspected distal acquired demyelinating symmetric neuropathy - Acute onset of weakness w/ walking and standing (stumbling) and neuropathic pain in distal upper extremities w/o a clear trigger. Exam notable for intact lower extremity reflexes, stumbling gait, 4/5 strength in distal bilateral upper and lower extremities.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Dysstasia, Gait disturbance, Haematocrit decreased, Haemoglobin normal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Suspected distal acquired demyelinating symmetric neuropathy - Acute onset of weakness w/ walking and standing (stumbling) and neuropathic pain in distal upper extremities w/o a clear trigger. Exam notable for intact lower extremity reflexes, stumbling gait, 4/5 strength in distal bilateral upper and lower extremities.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Muscular weakness, Neuralgia, Platelet count normal, Protein total normal, Red blood cell sedimentation rate normal
Clinical narrative: Suspected distal acquired demyelinating symmetric neuropathy - Acute onset of weakness w/ walking and standing (stumbling) and neuropathic pain in distal upper extremities w/o a clear trigger. Exam notable for intact lower extremity reflexes, stumbling gait, 4/5 strength in distal bilateral upper and lower extremities.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: White blood cell count normal
Clinical narrative: Suspected distal acquired demyelinating symmetric neuropathy - Acute onset of weakness w/ walking and standing (stumbling) and neuropathic pain in distal upper extremities w/o a clear trigger. Exam notable for intact lower extremity reflexes, stumbling gait, 4/5 strength in distal bilateral upper and lower extremities.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: peds dose given to an adult
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother of child reported (via telephone) swelling at the injection site and pain, injection site was also hot to the touch
Age: 46.0
Sex: M
Vaccine: PNC20
Symptoms: Dizziness, Electrocardiogram normal, Headache, Palpitations
Clinical narrative: Patient received the Prevnar vaccination at 1600, hemodialysis treatment ended at 1601, discharged from dialysis clinic post hemostasis, presented to ER at 1839 with complaints of "feeling like heart is racing", headache and lightheadedness. Was treated with Benadryl, tylenol and pain medication. Per hospital EMR, EKG was normal, pt in otherwise in acute distress, was discharged.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: 10 days after my shot, my resting heart rate went from 53 to 64, and now it is up to 73. My heart was tested coincidentally through an echo and was shown to be healthy on 01/10/2025. My heart rate has been around mid-50s since I take Matzim 240 for my Afib. It has never been in this range, and there were absolutely no other reasons except a reaction to the vaccine. My question is whether it will ever go down to my earlier ones? I always had Moderna and had no side effects of any sort. This time it was Pfizer which seems to have more cardiac side effects than Moderna
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm
Clinical narrative: Arm is very red and hot to touch. Also itchy. Advised to see MD to determine if cellulitis.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain, Swelling, Tenderness
Clinical narrative: pt received vaccine and 2 days later noticed quarter swelling and pain.  pt also started with pain all along left arm where vaccine was given.   pt is able to move arm and use it. Tender to touch along arm. no redness
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with covid/ended up getting the covid; diagnosed with covid/ended up getting the covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 17-year-old female patient received BNT162b2 (BNT162B2), on 13May2021 as dose 1, single (Batch/Lot number: unknown) and on 03Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The mother informed that her 17.5 year old daughter had no issues with the first vaccine, didn't believe she has gotten any others after the second dose. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with covid/ended up getting the covid".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021655658 same patient/product, different events;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is still hurting/the pain was unbearable; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 82-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Feb2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, (Manufacturer unknown)), for COVID-19 immunisation, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose 2, (Manufacturer unknown)), for COVID-19 immunisation, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose 3 booster, (Manufacturer unknown)), for COVID-19 immunisation, reaction(s): "No adverse effect". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "arm is still hurting/the pain was unbearable".  Additional information: The patient called for the Pfizer covid vaccine which she received on 06Feb2025.  She reported that her arm still his still hurting and she wanted to know if this is a normal side effect and if she could do something to get rid of it. The pain was unbearable. She claimed to have taken others, thinks this was her fourth shot and had no problems with the other shots.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Itchy; pain/ sore where the injection/still tender and it still feels hot; pain/ sore where the injection/still tender and it still feels hot; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 13Feb2025 as dose number unknown, single (Lot number: LN5490, Expiration Date: 31Oct2025) at the age of 63 years, in left arm for immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: MOUNJARO taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (I have the last two years), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 13Feb2025, outcome "unknown", described as "Itchy"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 13Feb2025, outcome "unknown" and all described as "pain/ sore where the injection/still tender and it still feels hot".  Additional information: Patient stated, She just wanted to know if it is normal. she had the Abrysvo RSV vaccines (Captured as: Abrysvo) two weeks ago and where they gave her the shot, it was still tender and it still feels hot and it was very itchy. I just wanted to know if that is normal, It's tender, it's sore where the injection was and it has been two weeks and it feels like a hot spot and it's very itchy on 13Feb2025 and Date of vaccination Abrysvo was on 13Feb2025. For Dose, route of administration and indication for Abrysvo: Patient stated, "The reason they gave it to me is I have asthma and diabetes. On Next day 14Feb2025 Consumer stated, "The itching feels like it is getting worse and the pain and the hotness is the same. No treatment was received. Time of vaccination (Abrysvo): Patient stated, she think it was 2:30 PM EST. and Vaccines did not administered on the same date of the Abrysvo vaccine Previous immunizations with the Pfizer vaccine Patient stated, she have taken your COVID vaccines. When probed for the details such as name, LOT# and expiration date of these COVID vaccines, consumer stated, Well she have the last two years because they do not keep them after that in a computer. They are gone. She do not have the COVID vaccine dates or anything with her, for Reassurance Patient stated Nope.
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  This product wasn't good for us. Any cures from this because I could not be off because of this. And this product was n't good for kids? Correct. We signed up for protection from Covid. Not to be followed and mocked without giving permission On God. I'm sick now because all got me on off What is why all plan with everyone acting out of these Covid protection shots on God. This was the family to go through this. No we were not the family to go through this On God. Why all misread the concept of head of household and breached access into our lives which totally unfair On God. Thing 1 and thing 2 shouldn't even be considered as a thought for any of Us here on earth On God. Aliens shouldn't have power to change my order of life to fit a science study that we waste even prepared for On God.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 24 hours after the vaccine, the injection site was very inflamed, red, painful, and hot to the touch. Contacted doctor's office 5 days after vaccination to confirm course of action and was informed to continue treating with ice packs and anti-inflammatory (ibuprofen). After 14 days the swelling was finally reduced, no longer painful, and a bruise/skin discolouration is still visible at the injection site. It is now 39 days post vaccination and I still have a small lump and discolouration at the injection site (not otherwise painful or itchy).
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site warmth, Swelling
Clinical narrative: 24 hours after the vaccine, the injection site was very inflamed, red, painful, and hot to the touch. Contacted doctor's office 5 days after vaccination to confirm course of action and was informed to continue treating with ice packs and anti-inflammatory (ibuprofen). After 14 days the swelling was finally reduced, no longer painful, and a bruise/skin discolouration is still visible at the injection site. It is now 39 days post vaccination and I still have a small lump and discolouration at the injection site (not otherwise painful or itchy).
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Blood test normal, Dizziness, Fatigue, Gait disturbance, Swelling face
Clinical narrative: She presented with complaints of extreme fatigue and swollen blood vessels on temples.  Her husband said she was walking with a tilt to the left.   When I took her blood pressure it was 138/68.  I was afraid of possible Guillian Barr muscle weakness/nerve involvement.         She went to ER the next day and they told her to do the Epley Maneuver for dizziness she reported there.  Her blood pressure at the hospital was 166/? as she reported to me.  Her bloodwork was normal, but they saw a heart condition she had been diagnosed with years ago.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Chest discomfort, Drooling, Lip swelling, Nausea
Clinical narrative: Pt received first dose of MMR vaccine, following clearance from specialist. Within 5 minutes of vaccine pt reported lip swelling, chest tightness, nausea, and drooling. Epinephrine was administered 10 minute post vaccine due to progressive symptoms. 911 was called and pt was transports to ER. She received benadryl and an oral steroid in route. Pt was monitored and discharged same day.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: vaccine error, patient already received Prevnar-20 on 5/4/24
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Biopsy artery abnormal, C-reactive protein normal, Eye irritation, Giant cell arteritis, Optic neuropathy
Clinical narrative: Symptoms of irritation of right eye with floaters and blurred vision on 11/28/22.  Was seen by ophthalmologist, MD on 11/29/2022 who reported concerns for optic neuropathy and retinal hemorrhage OD.  On 12/05/2022 suddenly developed worsening vision of left eye. Was seen by ophthalmologist, MD on 12/06/2022 who confirmed optic neuropathy involving left eye as well as right eye. Was seen by retinal specialist, MD on 12/07/22 who confirmed findings in both eyes. Started on oral prednisone 40mg/day. Was seen by neuro-ophthalmologist, MD at University on 12/09/2022 who confirmed findings and made provisional diagnosis of giant cell arteritis. Admitted to Univ Hospital on 12/09/22 and began IV solu-medrol x 3 days, followed by high dose (60mg/day) oral prednisone on discharge. Giant cell arteritis was confirmed by temporal artery biopsy performed on 12/20/2022.  Since Jan 2023 has received monthly infusions of Actemra(tocilizumab) to present day.
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Red blood cell sedimentation rate normal, Vision blurred, Visual impairment, Vitreous floaters
Clinical narrative: Symptoms of irritation of right eye with floaters and blurred vision on 11/28/22.  Was seen by ophthalmologist, MD on 11/29/2022 who reported concerns for optic neuropathy and retinal hemorrhage OD.  On 12/05/2022 suddenly developed worsening vision of left eye. Was seen by ophthalmologist, MD on 12/06/2022 who confirmed optic neuropathy involving left eye as well as right eye. Was seen by retinal specialist, MD on 12/07/22 who confirmed findings in both eyes. Started on oral prednisone 40mg/day. Was seen by neuro-ophthalmologist, MD at University on 12/09/2022 who confirmed findings and made provisional diagnosis of giant cell arteritis. Admitted to Univ Hospital on 12/09/22 and began IV solu-medrol x 3 days, followed by high dose (60mg/day) oral prednisone on discharge. Giant cell arteritis was confirmed by temporal artery biopsy performed on 12/20/2022.  Since Jan 2023 has received monthly infusions of Actemra(tocilizumab) to present day.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Pt. fainted directly after injection.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye discharge, Headache, Periorbital swelling
Clinical narrative: pt came to pharmacy and stated that she called her dr  stating she experienced  a rite eye discharge, headache, puffy eyelid with blisters.
Age: 85.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Had normal/uneventful vaccine administered on 2/25/25. Pt called 3/1/25 to ask about her vaccine; she said she took the band-aid off several days later and noticed a lump. She said at first there was redness/swelling/pain at the injection site; but redness/swellling/pain went away and now there is a lump. Pt. reports no fever/systemic side effects occurred. Injection site no longer red/painful. I told her I would call her Monday 3/3/25 to see how she was doing; she understood to go to ER if she developed fever. etc. or if injection site worsened. 3/3/25; pt. reports no other side effects just the lump. At first she said it was 1/2 the size (decreased), but then she said it is the same size. (1/2 of a marble); she reports no pain. She said she pressed on it hard, and there is no pain. We discussed vaccines can cause redness/swelliing at the injection site temporarily, but lumps are not as common/atypical response. I told her it could take some time for it to go away  (several weeks?). I told her I would file a report and call her if I needed anymore informaton. She seemed satisfied with the follow-up efforts. She knows to go to the doctor if necessary, but declined on 3/1/25 Saturday, and did not seem interested in being seen on 3/3/25. She reports no history of any problems/side effects with vaccines. I have given her vaccines in the past with  no responses like this.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pain, Injection site rash, Neuralgia, Sleep disorder
Clinical narrative: pain and rash at the injection site, nerve pain like symptom, disrupt sleep. worst at 2 weeks mark, get little better overtime but still has significant pain that disrupt sleep. Has not seen by PCP yet even though patient was told to contact PCP asap
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Fatigue, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Stomach cramps, severe neck and back stiffness, low grade fever, fatigue
Age: 0.33
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Blood in stool one week later - resolved within one week.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Pregnancy test was positive in the clinic during the day of the visit. She was approximately 9 weeks pregnant at the time. Estimated date of delivery is 09/11/25.
Age: 15.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pregnancy test was positive in the clinic during the day of the visit. She was approximately 9 weeks pregnant at the time. Estimated date of delivery is 09/11/25.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: woke up with a stuffy nose; Cough; Headache; she had a sore throat; This non-serious case was reported by a consumer and described the occurrence of sore throat in a 60-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24-FEB-2025, the patient received the 1st dose of Shingles vaccine (intramuscular, left arm). On 24-FEB-2025, less than a day after receiving Shingles vaccine, the patient experienced sore throat (Verbatim: she had a sore throat). On 25-FEB-2025, the patient experienced nasal stuffiness (Verbatim: woke up with a stuffy nose), cough (Verbatim: Cough) and headache (Verbatim: Headache). On 25-FEB-2025, the outcome of the sore throat was resolved. The outcome of the nasal stuffiness, cough and headache were not resolved.   It was unknown if the reporter considered the sore throat, nasal stuffiness, cough and headache to be related to Shingles vaccine.     It was unknown if the company considered the sore throat, nasal stuffiness, cough and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-FEB-2025 The reporter stated that she received Shingrix the day before reporting. She stated last night she had a sore throat but had gone away.  At the time of reporting, she woke up with a stuffy nose, cough and headache that she had not recovered from yet.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: A patient received the first Shingrix dose on 7/27/2021 and never received his second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 27-JUL-2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: A patient received the first Shingrix dose on 7/27/2021 and never received his second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 22-FEB-2025 and 24-FEB-2025 A patient received the first Shingrix dose on 27-JUL-2021 and never received his second dose.  If he were to get one now would he have to start the series over or would this count as his second dose. The Vaccine Administration Facility is the same as Primary Reporter. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Ankle fracture, Cardiac failure, Condition aggravated, Incomplete course of vaccination, Myocardial infarction
Clinical narrative: Heart failure; Heart attack; Broken ankle; This serious case was reported by a consumer via call center representative and described the occurrence of cardiac failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus (Diabetes type 1 (diagnosed prior the administration of Shingrix)) and cardiac failure (Heart failures before and after the first dose of Shingrix).   On 10-APR-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced cardiac failure (Verbatim: Heart failure) (serious criteria GSK medically significant), heart attack (Verbatim: Heart attack) (serious criteria GSK medically significant) and ankle fracture (Verbatim: Broken ankle). The outcome of the cardiac failure, heart attack and ankle fracture were unknown.   The reporter considered the cardiac failure, heart attack and ankle fracture to be unrelated to Shingrix.   The company considered the cardiac failure, heart attack and ankle fracture to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 24-FEB-2025 A member of the public call to asked if she could receive directly the second dose of Shingrix after she had the first one on 10th April 2024, or if she should restart the first dose to finally get that second. She mentioned to be diagnosed with diabetes type I before having the first dose, but also to have had a broken ankle, a heart attack and a heart failure were unrelated to the vaccine administration, since the first dose was given to date. Patient had heart attack, heart failure, broken ankle after Shingrix first dose.; Sender's Comments: Cardiac failure and  Myocardial infarction are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Vaccine: PNC20
Symptoms: Device connection issue
Clinical narrative: the adaptor is damaged or broken when trying to administer it; the adaptor is damaged or broken when trying to administer it; This is a spontaneous report received from an Other HCP from product quality group.  No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), (Lot number: LJ5280, Expiration Date: 30Apr2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE CONNECTION ISSUE (non-serious), outcome "unknown" and all described as "the adaptor is damaged or broken when trying to administer it".  The reporter considered "the adaptor is damaged or broken when trying to administer it" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "the adaptor is damaged or broken when trying to administer it" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: the reporter was unable to administer PREVNAR 20 to the patient and it looked like the adaptor was damaged or broken when trying to administer it. Reporter stated that it was only one dose. NDC reported as "00052000-01".
Age: 0.08
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Accidental use in 1mo year old patient with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 1 month old and unknown gender patient who received with no reported adverse event while receiving vaccine influenza USP trival A-B subvirion NO preservative vaccine [Fluzone].  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On 26-Feb-2025, the patient received 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection lot number not reported via intramuscular route in unknown administration site for Influenza vaccination (Influenza immunisation) (product administered to patient of inappropriate age) (Latency same day)  Information on the batch number could not be requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Vaccine: IPV
Symptoms: No adverse event, Off label use
Clinical narrative: intentional off label prescription by hcp: imovax prescribed with off label diagnosis other specified personal risk factors, not elsewhere classified with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 60-year-old and unknown gender patient and had intentional off label prescription by hcp (healthcare professional): IPV (VERO) [Imovax] prescribed with off label diagnosis other specified personal risk factors, not elsewhere classified with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, intentional off label prescription by HCP: suspect IPV (VERO) Suspension for injection 1 ml twice (expiry date, lot number not reported) via intramuscular route in unknown administration site prescribed with off label diagnosis Other specified personal risk factors, not elsewhere classified (Disease risk factor) with no reported adverse event (off label use) (latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence will not be available.  Action taken was not applicable.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: a six month-old boy received the diluent only, instead of the intended ACT- HIB vaccine and not the powder portion of the vaccine with no reported adverse event; Initial information received on regarding an unsolicited valid  non-serious case received from a other health professional along with live follow up both are processed together on 25-Feb-2025.  This case involves a 6 months old male patient to whom had received the diluent only, instead of the intended HIB (PRP/T) Vaccine [ACT-HIB] and not the powder portion of the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation.  On 20-Feb-2025, the patient received a 0.5 ml dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, frequency: once, lot UK169AC and expiry date: 28-Feb-2026) via intramuscular route in unknown administration site as prophylactic vaccination (immunization) and received the diluent only, instead of the intended act-hib vaccine and not the powder portion of the vaccine with no reported adverse event (product preparation error) (latency: same day).  Reportedly: "She states that they are in the practice of removing the little tiny square label which used to have both the lot number and expiration date printed on it, and putting it on a piece of paper for documentation/ record keeping. But now the vaccine label has a tiny piece of paper which doesn't include the expiration date, so they have to take the whole label off and when that is done, the two vials for the vaccine look basically the same, aside from some red writing. So the new labels do not work with their tracking protocol. She feels that there should be some better safeguards. She states that ACT-HIB is the only vaccine that they still use that utilizes this kind of system for 2-component vaccines. She mentions one manufacturer that uses an elastic-tab that keeps the two components hooked together, which she states is a really great feature. She reports that Merck now puts their diluent in a pre-filled syringe, packaged with the vaccine needing reconstitution."  Action taken; not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: They gave it to the child 1 week early with no reported adverse event; Initial information received on 25-Feb-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [daptacel] 1 week early with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN, hepatitis A vaccine (hepatitis A) for Immunisation and HIB vaccine (HIB vaccine), all for Immunisation.  On 25-Feb-2025, the patient received standard dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection once with lot 3CA25C1 and expiry date 30-Apr-2026 via intramuscular route in the right thigh for Immunization 1 week early with no reported adverse event (inappropriate schedule of product administration) (Latency same day).   Action taken was not applicable.  Reportedly, they gave it to the child 1 week early and she seeking for recommendations and what adverse reaction to watch for.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.67
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administered a booster dose of fluzone np to a 9-month-old earlier than scheduled with no reported adverse event; Initial information received on 26-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who was administered a booster dose of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] earlier than scheduled with no reported adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  . On 29-Jan-2025 patient received an unknown dose 1 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date and lot not reported) via unknown route in unknown administration site for Influenza.  On 11-Feb-2025, the patient received an unknown booster dose 2 of influenza USP TRIVAL A-B subvirion no preservative vaccine (expiry date- 30-JUN-2025 and lot U8465BA) via unknown route in unknown administration sit for Influenza earlier than scheduled with no reported adverse event  (inappropriate schedule of product administration) (latency- same day).   Information on the batch number for dose 1 was requested corresponding to the one at time of event occurrence.   Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.