chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: inadvertent administration of the vaccine after a temperature excursion (below freezing); This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: inadvertent administration of the vaccine after a temperature excursion (below freezing)). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-JUL-2025 The nurse reported that a patient had been administered a Boostrix vaccine after transport (from nine ante meridiem until nine fifteen ante meridiem) when the temperature was around twenty-seven degrees Fahrenheit and had dropped to negative five point five degrees Fahrenheit which led to, incorrect storage of drug. The reporter mentioned that no vaccination date, vaccine details, or patient demographics details were obtained or specified by the anonymous healthcare provider during the call.
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: Arexvy - Expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: Arexvy - Expired dose). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 10-JUL-2025 The nurse reported that a patient received an Arexvy vaccine and they noticed that one of the vials was expired, which led to expired vaccine used. The medical information specialist contacted the nurse, via phone, in order to get more information about this event. The nurse mentioned that one of the vials was expired (not mentioned if it was the lyophilized vial or the vial with the diluent).
Sex: F
Vaccine: COVID19
Symptoms: Near death experience, Urticaria chronic
Clinical narrative: I think I am dying from this vaccine; experiencing "hives" since June 2024 / Chronic spontaneous hives; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 048221A/048621A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2025, the patient received fourth dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. In June 2024, the patient experienced URTICARIA CHRONIC (experiencing "hives" since June 2024 / Chronic spontaneous hives). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) (seriousness criterion medically significant). The patient was treated with Prednisone for Hives, at an unspecified dose and frequency. At the time of the report, NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) outcome was unknown and URTICARIA CHRONIC (experiencing "hives" since June 2024 / Chronic spontaneous hives) had not resolved.            Concomitant medications were not reported.  The reporter shared that patient had reached out to multiple specialists, Oncologist, Rheumatologist, and Allergist.  The reporter shared that antihistamines and prednisone did not help to treat the hives. The reporter mentioned that her dermatologist, allergist, rheumatologist, and family doctor said that patient had chronic spontaneous hives.   The reporter added that patient had received the vaccine shots except for year, 2025.   It was unknown if the patient experienced any additional symptoms/events.   This case was linked to MOD-2022-516527 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 0.5
Sex: M
Vaccine: COVID19, RVX, RVX, TDAP
Symptoms: Irritability, Pyrexia, Somnolence
Clinical narrative: sleepy; irritable; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of SOMNOLENCE (sleepy), IRRITABILITY (irritable) and PYREXIA (fever) in a 6-month-old male patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect products included non-company products RSV vaccine for an unknown indication, Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for an unknown indication and Rotavirus vaccine for an unknown indication.    No Medical History information was reported.   On 11-Jul-2025, the patient received first dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) 1 dosage form, dose of RSV vaccine (unknown route) 1 dosage form, dose of Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) (unknown route) 1 dosage form and dose of Rotavirus vaccine (unknown route) 1 dosage form. On 11-Jul-2025, the patient experienced SOMNOLENCE (sleepy), IRRITABILITY (irritable) and PYREXIA (fever). The patient was treated with Paracetamol (Tylenol infant) in July 2025 at a dose of 2 milliliter every four hours. On 12-Jul-2025, SOMNOLENCE (sleepy), IRRITABILITY (irritable) and PYREXIA (fever) had resolved.        For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications provided by the reporter. It was reported that Infant received first dose of Moderna Covid vaccine along with RSV, TDaP, rotavirus, and other standard six-month vaccines. Post vaccination patient was developed fever and patient was sleepy with irritable symptom which was started about two hours after vaccination; side effects were lasted approximately 36 hours. The patient did not experience any additional symptoms or events.
Age: 79.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blister, Herpes zoster, Neck pain, Pain, Paraesthesia
Clinical narrative: Two (2) days after receiving the first Shingrix vaccine shot I began having a sore/tender area at base of my neck. By Saturday 4 days post injection blisters formed in that area which was the size of a silver dollar.  I also had stinging/tingling across my shoulder and into my neck.  Next day I was seen at urgent care and diagnosed with shingles and prescribed an antiviral med and topical lidocaine. HX:  I received the original shingles vaccine around 2005 and 2 years later broke out in a more severe case of shingles compared to this episode.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 RNA increased
Clinical narrative: HOSPITALIZATION AND DEATH RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID VACCINE SERIES
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Induration, Pain, Rash, Rash erythematous, Skin warm
Clinical narrative: The day after patient experienced swelling, and the development of a streaky rash. The day after pain got worse and is now decribe as shooting pain rash is red, hot, and fells hard to the touch per pt.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Swelling
Clinical narrative: The day after patient experienced swelling, and the development of a streaky rash. The day after pain got worse and is now decribe as shooting pain rash is red, hot, and fells hard to the touch per pt.
Age: 67.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Peripheral swelling, Pyrexia
Clinical narrative: Patient states she experienced a fever and developed a red and swollen arm. The patient showed me a picture in which the redness traveled from the injection site down to her elbow. She states these symptoms lasted for ~1 week.
Age: 74.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Found out right after patient left that the antigen component of Arexvy was expired on 7/6/25 (administered on 7/15/25). Checked with patient that she is not experiencing any unusual side effects other than sore arms. Patient will return to pharmacy for revaccination as recommended by the CDC.
Age: 1.33
Sex: F
Vaccine: UNK
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Autonomic nervous system imbalance, Blood creatine phosphokinase decreased, Burning sensation, Cardiac disorder
Clinical narrative: Left shoulder pain and numbness. Burning sensation down  shoulder and arm. Weakness in arm. Onset within 48 hours of injection but progressed until I received treatment in 2022.  Poly neuropathy starting in 2022 and has continued into 2025.  Chronic fatigue since 2021. Vision changes, vertigo , tachycardia and other cardiac issues starting in October 2024 and since continued. Had to resign from job as RN due to chronic and worsening symptoms. Dx autonomic dysfunction.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram QT prolonged, Electrocardiogram ambulatory, Fatigue, Haemangioma of bone
Clinical narrative: Left shoulder pain and numbness. Burning sensation down  shoulder and arm. Weakness in arm. Onset within 48 hours of injection but progressed until I received treatment in 2022.  Poly neuropathy starting in 2022 and has continued into 2025.  Chronic fatigue since 2021. Vision changes, vertigo , tachycardia and other cardiac issues starting in October 2024 and since continued. Had to resign from job as RN due to chronic and worsening symptoms. Dx autonomic dysfunction.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Muscular weakness
Clinical narrative: Left shoulder pain and numbness. Burning sensation down  shoulder and arm. Weakness in arm. Onset within 48 hours of injection but progressed until I received treatment in 2022.  Poly neuropathy starting in 2022 and has continued into 2025.  Chronic fatigue since 2021. Vision changes, vertigo , tachycardia and other cardiac issues starting in October 2024 and since continued. Had to resign from job as RN due to chronic and worsening symptoms. Dx autonomic dysfunction.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neutrophil count abnormal, Paranasal cyst, Polyneuropathy, Sleep study normal, Tachycardia
Clinical narrative: Left shoulder pain and numbness. Burning sensation down  shoulder and arm. Weakness in arm. Onset within 48 hours of injection but progressed until I received treatment in 2022.  Poly neuropathy starting in 2022 and has continued into 2025.  Chronic fatigue since 2021. Vision changes, vertigo , tachycardia and other cardiac issues starting in October 2024 and since continued. Had to resign from job as RN due to chronic and worsening symptoms. Dx autonomic dysfunction.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Visual impairment, White blood cell count increased
Clinical narrative: Left shoulder pain and numbness. Burning sensation down  shoulder and arm. Weakness in arm. Onset within 48 hours of injection but progressed until I received treatment in 2022.  Poly neuropathy starting in 2022 and has continued into 2025.  Chronic fatigue since 2021. Vision changes, vertigo , tachycardia and other cardiac issues starting in October 2024 and since continued. Had to resign from job as RN due to chronic and worsening symptoms. Dx autonomic dysfunction.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac monitoring, Cardiac stress test, Dyspnoea, Echocardiogram
Clinical narrative: On 6 December 2021 I was overcome by an irregular heartbeat, fatigue, weakness, shortness of breath and heart palpitations. I saw my primary caregiver who referred me to a cardiologist. After testing (Echocardiogram, sonogram, stress test and heart monitoring) it was determined that I had mild Mitral and Tricuspid Valve regurgitation with occasional unifocal PVC ( palpitations).
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Heart rate irregular, Mitral valve incompetence, Palpitations, Tricuspid valve incompetence
Clinical narrative: On 6 December 2021 I was overcome by an irregular heartbeat, fatigue, weakness, shortness of breath and heart palpitations. I saw my primary caregiver who referred me to a cardiologist. After testing (Echocardiogram, sonogram, stress test and heart monitoring) it was determined that I had mild Mitral and Tricuspid Valve regurgitation with occasional unifocal PVC ( palpitations).
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, Ventricular extrasystoles
Clinical narrative: On 6 December 2021 I was overcome by an irregular heartbeat, fatigue, weakness, shortness of breath and heart palpitations. I saw my primary caregiver who referred me to a cardiologist. After testing (Echocardiogram, sonogram, stress test and heart monitoring) it was determined that I had mild Mitral and Tricuspid Valve regurgitation with occasional unifocal PVC ( palpitations).
Age: 2.0
Sex: M
Vaccine: PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was given, no adverse affect reported or seen by nurse in clinic
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Wrong product administered
Clinical narrative: Pt was to receive RSV vaccine on 7/9/2025.  Nurse inadvertently administered Zoster vaccine instead.  Pt has already had 2 doses of Shingrix.  Pt reported on 7/12/25 that she had "felt icky" since 7/10/2025, but only mentioned having the standard reactions from receiving a Shingrix vaccine.  Provider has discussed the patients concerns, and pt is no longer having any kind of symptoms from the vaccine.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt had no adverse reactions at time of vaccine administration. I told the provider what happened, called mom of the pt and let her know what happened, what to watch for. Called the health department and wasn't able to get ahold of anyone. I did send an email to vaccine contact at the health department.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Hypotonia, Pallor
Clinical narrative: Client was visibly nervous and when asked stated she was ok getting shots. Gave both vaccinations in the right deltoid and client stated she was fine, with in minutes client became pale and put her head down and went limp. Client came to right away and I called for assistance from the administration assistant. We applied cold clothes the back of her neck and forehead. Client took a drink of water and then started vomiting. With minutes client passed out again. Instructed assistant to call 911 so she could be evaluated. Someone from the Ambulance department came from Social Services across the hall within minutes. I took client bp 103/67 pulse 86. Ambulance personnel assessed client and ambulance staff came and transported client to local ER to be further evaluated. Client stated she felt better and was able to ambulate to the ambulance. (withheld name)- RN
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Pt reported hair loss following the vaccine. She said that is has "slowed down" so she was ready to get her second dose. She stated she has researched and saw that it was a rare SE, and wanted to get the vaccine.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram, Full blood count, Headache, Metabolic function test, Respiratory pathogen panel
Clinical narrative: Severe headaches since the vaccine. Had a siezure and was taken to the ER
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Seizure
Clinical narrative: Severe headaches since the vaccine. Had a siezure and was taken to the ER
Age: 81.0
Sex: M
Vaccine: PNC21
Symptoms: Pruritus
Clinical narrative: Pt stated: "About 8 hours [after vaccine administration], I experienced intense itching in several places, including my neck and arms. It was a VERY unusual sensation, almost electrical. It subsided after about 45 minutes, and didn't recur.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Rash
Clinical narrative: Significant rash developed that was most consistent with eczema. Patient was seen in clinic for evaluation. No threat to life.
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient given Prevnat 20 vaccine and started on glipizide at appt on 7/9/2025.  Woke up on 7/10/2025 with erythematous rash on upper arms. Glipizide was stopped.  Rash has continued to progress since with areas on torso, proximal lower extremities, lots of white pustular lesions overlying erythematous base, widespread. No itching or pain. No fever or chills.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Basophil count normal, Eosinophil count normal, Haematocrit decreased, Haemoglobin normal, Lymphocyte count normal
Clinical narrative: Rash that started on the face and moving onto the chest
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Rash that started on the face and moving onto the chest
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage, Rash
Clinical narrative: Rash that started on the face and moving onto the chest
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Red blood cell count normal, Red cell distribution width normal, White blood cell count normal
Clinical narrative: Rash that started on the face and moving onto the chest
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: Severe Headache
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Facial paralysis, Facial paresis, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 7/10 - Woke with headache in left parietal area.  Mild/intermittent, occurring daily.  Treated with Ibuprofen 600 mg.  7/14 - Began with numbness and weakness on the left side of face.  Progressed with left sided facial drooping and numbness on left side of the tongue. Treated with Prednisone 20 mg 3 pills daily for 6 days followed by 2 pills daily for 3 days and 1 pill daily for 3 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pruritus, Injection site urticaria, Pruritus
Clinical narrative: According to patient  two hours after immunization, the patient began experiencing itchiness at the injection site. By the end of the day patient had itchiness all over the body and hives on the injection site and took Benadryl for it.  Patient does not suffer from itchiness, but injection site is still  bruised
Age: 1.25
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: He was getting vaccines at 15 month well check.  Mother has elected to space out vaccines, so schedule is altered,  He got MMR and Prevnar at 12 month well.  Prevnar vaccine was given today in clinic- it was an additional dose that he did not need/off schedule.  No problems noted after vaccine was given.  Baby has had no adverse effects.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Atrial flutter, Chills, Pyrexia
Clinical narrative: Patient received the vaccine. 30 minutes later he developed chills, fever, rigors and afib with rvr.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Rash for 2 weeks and headache couple days
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Injection site erythema
Clinical narrative: Got prevnar on 7/10/2025--2:30 am--nausea, fatigue. Chills. ? Temp. Sweats.  Rhinorrhea--last 48 hours. Right neck pain.  Redness to arm where prevnar was given.  No numbness to the arm.  No cough. No SOB.  No lower GI symptoms.  Tylenol / motrin recommended
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Neck pain, Rhinorrhoea
Clinical narrative: Got prevnar on 7/10/2025--2:30 am--nausea, fatigue. Chills. ? Temp. Sweats.  Rhinorrhea--last 48 hours. Right neck pain.  Redness to arm where prevnar was given.  No numbness to the arm.  No cough. No SOB.  No lower GI symptoms.  Tylenol / motrin recommended
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac function test, Cardiac perfusion defect, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Normally a morning runner with 3-5 miles/ day. Just over 2 weeks past the Covid Booster shot (had the initial 2 shots) I was so fatigued I could not walk up the hill I run every day.  Tried it multiple times over the next couple of days with the same effect.  As a former mini Triathlon winner I was in very good shape and ran every day.  The fatigue, in ability to breath, dizzy, and light headed was a totally new experience.  I set up an appointment with personal physician for 10+ years and he set up a visit with Cardiologist. Ran a series of stress tests, EKG and other cardiac tests.  Reported Cardiac Perfusion Defect.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: Normally a morning runner with 3-5 miles/ day. Just over 2 weeks past the Covid Booster shot (had the initial 2 shots) I was so fatigued I could not walk up the hill I run every day.  Tried it multiple times over the next couple of days with the same effect.  As a former mini Triathlon winner I was in very good shape and ran every day.  The fatigue, in ability to breath, dizzy, and light headed was a totally new experience.  I set up an appointment with personal physician for 10+ years and he set up a visit with Cardiologist. Ran a series of stress tests, EKG and other cardiac tests.  Reported Cardiac Perfusion Defect.
Age: 1.92
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC15, VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Client began scratching neck shortly after vaccines while waiting in the lobby.  Redness/welts noted to back of neck and waistline.  Client also noted to have diffuse reddened welts to back.   Client was in no distress and no airway distress noted.  911 was called and client was transported to (withheld name) Hospital.  Client discharged home from ER per mother.
Age: 1.33
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: Pt was accidently given Vaxelis when they were supposed to just get HIB
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Within 24 we were notified by daycare provider that her injection site might need to be looked at. At first it was about a 1 inch diameter red circle. After 48 hours the reaction had grown to over 5 inches in diameter, became red, hot, and swollen. At 60 hours there were signs of welts within the red circle.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood magnesium, Electrocardiogram, Full blood count, Headache, Human chorionic gonadotropin
Clinical narrative: Headache, syncope
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Lipase, Liver function test, Metabolic function test, Syncope
Clinical narrative: Headache, syncope
Age: 102.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received the RSV vaccine 04/2024 at a pharmacy in (withheld state). She received the RSV vaccine again on 07/15/2025 at pharmacy in (withheld different state). Her vaccine record was not in the (withheld state) Immunization Registry and our default transaction history goes back one year (unless you manually change the year to go back farther). When the pharmacist check data base and the default one year transaction history it seemed as if the patient had never received the RSV vaccine. The patient did not remember that she had already received it. I spoke with her 07/16/2025 and she is fine/doing well with no adverse events.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Diverticulitis
Clinical narrative: Diverticulitis
Age: 70.0
Sex: F
Vaccine: PNC21
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Patient received Capvaxive vaccine on 6/23/2025 in her right deltoid, was monitored for 15 minutes afterward and tolerated immunization administration well. She states she developed mild arm pain that evening, which has persisted since that time, for approximately 23 days. She has taken ibuprofen with some relief. She reports the pain is localized to the muscle, and hurts when raising her right arm off a table. She denies any signs of infection, including redness, swelling, warmth, or fever. Advised patient to try alternating acetaminophen and ibuprofen, apply warm or cold compresses as needed, offered patient appointment to be seen today or tomorrow and she is unable to come in. Discussed other evaluation opportunities with patient, and she plans to go to a walk in orthopedics clinic this week for evaluation.
Age: 64.0
Sex: F
Vaccine: COVID19, PNC20, RSV
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported reaction to either COVID or Prevnar vaccine administered in the left arm. Patient reports onset of headaches (reports worse than typical HA that she has due to allergies/congestion) and fatigue starting the following day. Two days after injection, patient reports delayed onset of swelling/redness/warmth of left arm close to injection site. Patient reports improvement and near resolution of symptoms nearly 2 weeks later but arm still appears slightly swollen and red, with no discomfort.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Blood chloride normal, Blood folate normal, Blood thyroid stimulating hormone normal, Carbon dioxide decreased, Electrocardiogram normal
Clinical narrative: Patient became sleepy, ultimately developing poor muscle tone, slow breathing, and seizure like movements. He was seen at a local ED and transferred to another ED for further care. He had labs, EKG, MRI, and admitted to hospital. While in the hospital he had seizure-like events - staring spells. EEG was done. He improved and was discharged home.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Electroencephalogram normal, Haematocrit decreased, Haemoglobin decreased, Hypotonia, Lymphocyte percentage
Clinical narrative: Patient became sleepy, ultimately developing poor muscle tone, slow breathing, and seizure like movements. He was seen at a local ED and transferred to another ED for further care. He had labs, EKG, MRI, and admitted to hospital. While in the hospital he had seizure-like events - staring spells. EEG was done. He improved and was discharged home.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Magnetic resonance imaging normal, Monocyte percentage increased, Neutrophil percentage, Platelet count normal, Respiratory rate decreased
Clinical narrative: Patient became sleepy, ultimately developing poor muscle tone, slow breathing, and seizure like movements. He was seen at a local ED and transferred to another ED for further care. He had labs, EKG, MRI, and admitted to hospital. While in the hospital he had seizure-like events - staring spells. EEG was done. He improved and was discharged home.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Seizure like phenomena, Somnolence, Staring, Transferrin saturation decreased, Vitamin B12 increased
Clinical narrative: Patient became sleepy, ultimately developing poor muscle tone, slow breathing, and seizure like movements. He was seen at a local ED and transferred to another ED for further care. He had labs, EKG, MRI, and admitted to hospital. While in the hospital he had seizure-like events - staring spells. EEG was done. He improved and was discharged home.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: White blood cell count normal
Clinical narrative: Patient became sleepy, ultimately developing poor muscle tone, slow breathing, and seizure like movements. He was seen at a local ED and transferred to another ED for further care. He had labs, EKG, MRI, and admitted to hospital. While in the hospital he had seizure-like events - staring spells. EEG was done. He improved and was discharged home.
Age: 19.0
Sex: M
Vaccine: HEP, MENB, TDAP
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: 1 dose(1 ml ) Engerix B given. Patient is 19 y/o . Engerix B vaccine given is for 20 y/o and older. Patient reported feeling tired the day of vaccination. Patient reported the following  symptoms the day after vaccination : body aches, headache, weakness, tiredness.  Patient informed the symptoms he described are most likely common after receiving vaccinations.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: On 07/15/2025 Patient, DOB 04/XX/20XX (MRN withheld) was seen in clinic by provider for a new patient visit including Vaccines. Patient was due for his MCV 4 , Hep A, and HPV.  Mother of the patient was given VIS prior to administration and the VAR was completed. Patients Hep A and Hpv vaccines were administered Intramuscular without issue. While his MCV 4 was administered Subcutaneous without issue. His MCV4 was discovered to be incorrectly administered Subcutaneously shortly after administering the dose. I quickly alerted Provider of the error, and we referred to the CDC website for direction on next steps. Per the CDC the vaccine does not need to be administered. I referred to the standing order for guidance as well. And precautionarily consulted with (withheld name). I was told by both providers that administering in the cite I did would cause slow absorption. Per protocol I also reached out to the patient/ parent of the patient to inform of this incident however the patient was unable to be reached. I also notified my immediate supervisor (name withheld) of the incident. In addition I also reported on VAERS. My goal in the future is to be more mindful of what medication I am administering and where.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Redness measuring 10 x 6 cm. Warm to touch. Per patient it is very itchy and hurts when laying down on her left side.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vision blurred
Clinical narrative: patient developed blurred vision the following day in the morning, lasted a few hours, came and went, now resolved without intervention
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PATIENT HAD A LARGE SWOLLEN RED CIRCLE SURROUNDING THE AREA THAT RECEIVED THE VACCINE
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Diarrhoea, Dizziness, Dizziness postural, Dysarthria, Dyskinesia
Clinical narrative: Symptoms started 7/12. Started having odd muscle spasms, head jerking, hands/arms fidget, dizziness, heart racing, nauseous, and slurred speech. He slept in a cold room and that helped. He slept almost all day 7/13. On 7/13 he got very hot and started feeling dizzy and got pale. Symptoms are starting to improve some today. He got dizzy upon sitting up too quickly today and got dizzy when he got over heated today. He has also had diarrhea 7/13.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Electrocardiogram normal, Feeling hot, Muscle spasms, Nausea, Pallor
Clinical narrative: Symptoms started 7/12. Started having odd muscle spasms, head jerking, hands/arms fidget, dizziness, heart racing, nauseous, and slurred speech. He slept in a cold room and that helped. He slept almost all day 7/13. On 7/13 he got very hot and started feeling dizzy and got pale. Symptoms are starting to improve some today. He got dizzy upon sitting up too quickly today and got dizzy when he got over heated today. He has also had diarrhea 7/13.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Palpitations
Clinical narrative: Symptoms started 7/12. Started having odd muscle spasms, head jerking, hands/arms fidget, dizziness, heart racing, nauseous, and slurred speech. He slept in a cold room and that helped. He slept almost all day 7/13. On 7/13 he got very hot and started feeling dizzy and got pale. Symptoms are starting to improve some today. He got dizzy upon sitting up too quickly today and got dizzy when he got over heated today. He has also had diarrhea 7/13.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Pallor, Presyncope, Syncope
Clinical narrative: Patient was in sitting position and within 2 minutes of getting the vaccine for pale and dizzy and fainted back into the patient bed. She lost consciousness for a few seconds then came immediately back and was talking and knew her name. We got her an ice pack and water. After about 5 minutes we sat her up but she proceeded to have nearvsuncope again donated her down, legs above their heart for about 20 minutes. Gave her apple juice as she had not eaten at all before coming to the office. We observed her here for another 30 minutes. She ate some cookies, felt well and left. On follow up phone call hours later mom felt she was still a little groggy. She was resting and hydrating.
Age: 0.33
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother notice, babies left thigh was red and swollen this morning at 10:00 AM, baby received vaccines yesterday. Mother then brought baby in to be checked by Dr. Rx hydrocortisone 2.5% topical cream was prescribed twice daily x 5day.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ankle brachial index, Blood gases, Blood test, Brain fog, Cardiac stress test
Clinical narrative: Was in great health prior to vaccines, was a labeled Ironman All World Athlete finishing in top 10% of my age group and a shell of that since the devastating effects of the COVID Vaccines. Chronic Respiratory Alkalosis, high heart rate, blood clot right leg, severe reduced exercise capacity, nerve pain, brain fog, blood flow affected, excruciating pain in lower legs, labored breathing during exercise, higher than normal heart rate when exercising,
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Computerised tomogram, Dyspnoea, Echocardiogram, Exercise tolerance decreased
Clinical narrative: Was in great health prior to vaccines, was a labeled Ironman All World Athlete finishing in top 10% of my age group and a shell of that since the devastating effects of the COVID Vaccines. Chronic Respiratory Alkalosis, high heart rate, blood clot right leg, severe reduced exercise capacity, nerve pain, brain fog, blood flow affected, excruciating pain in lower legs, labored breathing during exercise, higher than normal heart rate when exercising,
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Magnetic resonance imaging, Nerve conduction studies, Neuralgia, Pain in extremity
Clinical narrative: Was in great health prior to vaccines, was a labeled Ironman All World Athlete finishing in top 10% of my age group and a shell of that since the devastating effects of the COVID Vaccines. Chronic Respiratory Alkalosis, high heart rate, blood clot right leg, severe reduced exercise capacity, nerve pain, brain fog, blood flow affected, excruciating pain in lower legs, labored breathing during exercise, higher than normal heart rate when exercising,
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory alkalosis, Thrombosis, Ultrasound scan, Vascular test, X-ray
Clinical narrative: Was in great health prior to vaccines, was a labeled Ironman All World Athlete finishing in top 10% of my age group and a shell of that since the devastating effects of the COVID Vaccines. Chronic Respiratory Alkalosis, high heart rate, blood clot right leg, severe reduced exercise capacity, nerve pain, brain fog, blood flow affected, excruciating pain in lower legs, labored breathing during exercise, higher than normal heart rate when exercising,
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Periorbital oedema
Clinical narrative: SHINGRIX VAC 7/14. Bilateral Erythema. Edema below both eye. (L) > (R). No other clear precipitation, factor. Will treat with Benadryl.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Product preparation issue
Clinical narrative: None - Pentacel vaccine was not given, just diluent was given
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Peripheral swelling, Pruritus, Wound
Clinical narrative: 5 bumps appear on her left arm at injection site; one bump on her right foot; bumps itch and open when scratched; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis.   On 30-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUL-2025, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: 5 bumps appear on her left arm at injection site), local swelling (Verbatim: one bump on her right foot) and pruritus (Verbatim: bumps itch and open when scratched). The outcome of the injection site swelling, local swelling and pruritus were not resolved.   It was unknown if the reporter considered the injection site swelling, local swelling and pruritus to be related to Shingrix.     It was unknown if the company considered the injection site swelling, local swelling and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUL-2025 The patient mentioned she had normal reactions following the vaccination (not disclosed) for the first two days following vaccination. However, she then had 5 bumps appear on her left arm at injection site and one bump on her right foot.   The patient mentioned that the bumps look like mosquito bites which itched, when scratched then they open up and the open bumps that hurt a little bit. The patient stated she did not take any medication and had no health concerns.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Diarrhoea, Infant irritability, Vomiting projectile
Clinical narrative: prolonged fussiness, projectile vomiting and diarrhea x 1 week after 4 mo vaccines
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Engerix-B pediatric dose was administered to an adult; Engerix-B pediatric dose was administered to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 37-year-old female patient who received HBV (Engerix B) (batch number 47XP4, expiry date 17-JUL-2027) for prophylaxis.   On 10-JUL-2025, the patient received the 3rd dose of Engerix B. On 10-JUL-2025, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose was administered to an adult) and underdose (Verbatim: Engerix-B pediatric dose was administered to an adult). The outcome of the adult use of a child product and underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JUL-2025 The nurse reported that the administration of a pediatric dose of Engerix-B to an adult patient, which led to adult use of a child product and underdose It was third dose in the Engerix-B series and nurse called to get guidance on how to proceed.  The reporter asked if an Engerix-B pediatric dose was administered to an adult, was that less effective and could it be combined with an adult dose The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Hypoaesthesia, Neck pain, Vaccination failure
Clinical narrative: suspected vaccination failure; seemed to think it was related to shingles; burning sensation; got this pain on the back of neck; neck felt numb to the touch; 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: seemed to think it was related to shingles), burning sensation (Verbatim: burning sensation), neck pain (Verbatim: got this pain on the back of neck) and neck numbness (Verbatim: neck felt numb to the touch). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure, shingles and neck numbness were not reported and the outcome of the burning sensation was resolved and the outcome of the neck pain was resolving.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, neck pain and neck numbness to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, burning sensation, neck pain and neck numbness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-JUL-2025 This case was reported by a patient via interactive digital media. The patient decided to get the Shingles shot a year ago and a couple of weeks ago a got this pain on the back of neck as if he/she had slept the wrong way. Well, it got worse and then the back of neck felt numb to the touch and then periodically the patient got this burning sensation as if someone was using a hot poker on the back of neck and that would come and go just about every hour or so. The patient made an appointment to see doctor and he/she was told that it was not muscle related but had more to do with skin. The patient had no redness whatsoever, but the doctor seemed to think it was related to shingles. The patient was prescribed Valacyclovir to fight the virus and so far after taking this after a few days the pain has subsided and that burning sensation has gone away. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization 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 Shingles vaccine.
Age: 40.0
Sex: F
Vaccine: DTAPIPV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertent administration of QUADRACEL to a patient that was intended to receive ADACEL with no reported adverse event; inadvertent administration of QUADRACEL to a patient that was intended to receive ADACEL with no reported adverse event; Initial information received on 14-Jul-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 40 years old female patient who was inadvertently administered with diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] that and was intended to receive diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Jul-2025, the patient received 0.5 ml of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine Suspension for injection with standard strength (expiry date- 03-OCT-2025 and lot U7908AB) once via intramuscular route in the right deltoid for Immunization instead of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot not reported) for prophylactic vaccination (Immunization) with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency- same day).  Reportedly, the caller was not aware of any treatment post administration. List concomitant: no other immunizations.   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: 14.0
Sex: F
Vaccine: DTPPVHBHPB, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was given a Vaxilis and a Tdap. The person that gave the immunizations meant to grab a Hep B but grabbed a Vaxilis instead. No side effects or reactions reported as as of today.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching at injection site; treated with hydrocortisone cr 1%
Age: 1.33
Sex: F
Vaccine: DTAP, PNC20
Symptoms: Expired product administered
Clinical narrative: Pt was here yesterday afternoon 7/16/25 for a late 15 month WCC with Dr. I administered the patient's scheduled vaccines, her pneumococcal 20 (prevnar 20) and dtap (infanrix) immunizations. However, while preparing the vaccines to be ready for administration, the expiration date on the dtap (infanrix) vaccine was misread and documented as 7-13-2026 and therefore administered. However, after further investigation while gathering other vaccines in the fridge where they were stored, re-evaluation of the date revealed that the expiration of the vaccine was actually 7-13-2025. Therefore the vaccine was 3 days expired. The remaining 1 vaccine dose left in the package was then removed from the vaccine refrigerator and both office manager and Dr. was notified. Attempted to reach parents to inform them of mistake, but no answer. Left a voicemail to call us back to discuss the issue. Further called VFC vaccine management and spoke with someone who reports no further side effects to look for except for the potentially less effective dose due to the expiration date. VFC reports the patient should have another dose of the same vaccine but that is not expired and complete a Vaers form. Spoke with the mother of the patient this morning around 9:50am and explained the situation and offered my sincerest apologies and explained that there is no additional side effects to be watching for and that recommended next steps would be to re-administer a second dose of the same vaccine to ensure effectiveness. Mom was very understanding and appreciative of the notification and that I called and checked to ensure there are no additional side effects or harm conducted to patient. Mom reports she is going to talk to her fiance, the patients father, when he arrives home from work to determine when she can come in for the vaccine as he has the vehicle. vaers form will be completed. Dr. and others are aware of the situation. As of now, there are no known side effects to the patient.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dyskinesia, Injection site swelling, Lethargy, Pyrexia, Tremor
Clinical narrative: Fever 103+ with jerking/ shaking. Left arm with minor injection site swelling at this time. Child is lethargic.  Pt with reaction to previous vaccines similar per mom.