chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Vaccination error. Patient had already received RSV vaccine on 12/19/2023. GRITs was not updated, prescriber recommended. We as well as the patient did not realize that she had already received it.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: pt had inadvertently received 2 doses of the high dose of the flu vaccine once in september and again in november
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Vaccination Error: Patient had already received RSV vaccine on 12/19/2023. Record was not updated. Prescriber hence recommended. We and the patient did not realize that he had already received at pharmacy.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Atrial fibrillation w rapid ventricular response
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After administrating the RPH a HEP-A the patient was waiting for proof and then her dad stated that she is complaining of dizziness. The tech that was completing the paper let the patient they could have a seat. As the RPH completed a vaccine for another pt a loud thud was heard. The RPH immediately came out of the room the pt was unconscious. The RPH went back to the room to get the epi pen but before it could be administered the pt awoke and was alert. We called 911 and had the pt wait with her parents to be checked out. While the waiting for EMS pt was given a water and a dum dum candy. When EMS arrived she was taken take out to the ambulance for further evaluation.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Patient experienced a syncopal episode immediately after receiving HPV vaccine. (Her mom was present) patient became very pale, said "I feel dizzy," then fainted.  I placed an ice pack on her neck and staff assisted her to a wheel chair to get her in bed. The bed was placed in Trendelenburg position. Once patient was alert enough, she was able to drink some water and eat a few crackers.  I checked her vital signs three times during this situation. She felt better after about 35 minutes, her blood pressure improved, and  she was able to go home in stable condition. I advised her to eat and rest this evening and contact our 24 hr nurse number this evening if any concerns. I also sent an FYI message to her PCP.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Carpal tunnel syndrome, Dyspepsia, Endoscopy upper gastrointestinal tract, Impaired work ability, Laboratory test
Clinical narrative: I was diagnosed with RA in January 2024. I had symptoms leading up to the diagnosis during 2022 and 2023. Shortly after the shot I had to see a GI MD - for slow digestion a symptom of RA. He scoped my esophogus and eventually prescribed metoclopramide. At that time I did not know if could be a symptom of RA. During late 22 and all of 23 I suffered from 1 and then 2 swollen fingers with no known cause. In 2024 more of my digits swelled and I had uncontrolled pain throughout my hands. My RA MD has tried me on 2-3 different courses and combinations of therapy.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Nerve conduction studies, Pain in extremity, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: I was diagnosed with RA in January 2024. I had symptoms leading up to the diagnosis during 2022 and 2023. Shortly after the shot I had to see a GI MD - for slow digestion a symptom of RA. He scoped my esophogus and eventually prescribed metoclopramide. At that time I did not know if could be a symptom of RA. During late 22 and all of 23 I suffered from 1 and then 2 swollen fingers with no known cause. In 2024 more of my digits swelled and I had uncontrolled pain throughout my hands. My RA MD has tried me on 2-3 different courses and combinations of therapy.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan, X-ray limb
Clinical narrative: I was diagnosed with RA in January 2024. I had symptoms leading up to the diagnosis during 2022 and 2023. Shortly after the shot I had to see a GI MD - for slow digestion a symptom of RA. He scoped my esophogus and eventually prescribed metoclopramide. At that time I did not know if could be a symptom of RA. During late 22 and all of 23 I suffered from 1 and then 2 swollen fingers with no known cause. In 2024 more of my digits swelled and I had uncontrolled pain throughout my hands. My RA MD has tried me on 2-3 different courses and combinations of therapy.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given another dose of Arexvy, but the patient has already received a dose on 1/9/24. Patient was contacted by the pharmacist when the discovery of the second dose of the vaccination was discovered through our Immunization Review.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Patient received a second dose of Arexvy - reported no adverse effects besides a sore arm.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of Arexvy - original dose in 2023
Age: 74.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Asthenia, Chills, Delusion, Gait inability, Headache
Clinical narrative: Patient reported high fever, chills, swollen shoulder, body aches, weakness ("couldn't walk"), delusions, headaches. Symptoms started in 2 hours. Swollen site of injection for a few days
Age: 74.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site swelling, Pain, Pyrexia, Swelling
Clinical narrative: Patient reported high fever, chills, swollen shoulder, body aches, weakness ("couldn't walk"), delusions, headaches. Symptoms started in 2 hours. Swollen site of injection for a few days
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm, redness, swelling and pain. Mother reported warm to touch. Redness surround almost entire deltoid. Diagnosed with Rt upper extremity cellulitis. treated with Keflex 250 mg/5ml - 20 ml by mouth 2 times daily x 10 days and Ibuprofen 200mg as needed for pain Follow up apt.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Boostrix to a 7 year old patient on December 13th 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number Y59D4, expiry date 16-JUN-2026) for prophylaxis.   On 13-DEC-2024, the patient received Boostrix. On 13-DEC-2024, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered Boostrix to a 7 year old patient on December 13th 2024). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-DEC-2024 The Healthcare Professional stated that they administered Boostrix to a 7 year old patient , which led to inappropriate age at vaccine administration.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abscess, Anal fistula
Clinical narrative: Personal abscess developed into anal fistula over the course of 2 months.
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Flank pain
Clinical narrative: Abdomen right side pain; Flank area pain; This non-serious case was reported by a physician via call center representative and described the occurrence of abdominal pain in a 49-year-old male patient who received HBV (Engerix B) (batch number 4KF75) for prophylaxis.   On 02-JUL-2024, the patient received the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced abdominal pain (Verbatim: Abdomen right side pain) and flank pain (Verbatim: Flank area pain). The outcome of the abdominal pain and flank pain were resolved.   It was unknown if the reporter considered the abdominal pain and flank pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the abdominal pain and flank pain to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:US2024AMR166104   Additional Information: GSK Receipt Date: 11-DEC-2024 The reporter reported that patient had received Engerix B in an urgent care facility. The patient had right side pain in his abdomen and also in his flank area since the first dose of Engerix B. For tolerance of 2nd dose of Engerix B , refer case US2024AMR166104.; Sender's Comments:  US-GSK-US2024AMR166104:Case for 2nd dose US-GSK-US2024AMR166104:1 st dose
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness). The outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     It was unknown if the company considered the dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-DEC-2024 The pharmacist asked that how long would dizziness from Shingrix last. The reporter confirmed that a patient was experiencing this reaction and when reporter was asked about the patient and product details, reporter said did not have it, a doctor was asking to the pharmacist how long the dizziness would last. The pharmacist did not even see the patient.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Innapropiate Schedule for vaccine (more than 6 months after first dose); This non-serious case was reported by a pharmacist 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 an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Innapropiate Schedule for vaccine (more than 6 months after first dose)). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-DEC-2024 Patient received first dose on twenty-twenty two (unspecified) (more than six months after 1st dose). Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. Pharmacist wants to know if they have to restart the series of which guidance can GlaxoSmithKline provide.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given to 15 month old; Kinrix on 09Dec2024 as dose 4 in the DTaP series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 09-DEC-2024, the patient received the 4th dose of Kinrix. On 09-DEC-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Given to 15 month old) and inappropriate schedule of vaccine administered (Verbatim: Kinrix on 09Dec2024 as dose 4 in the DTaP series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-DEC-2024 The Healthcare Professional stated that a 15 month old female patient was inadvertently given Kinrix on 9th December 2024 as dose 4 in the DTaP series, with dose 3 being administered 9 months prior, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. Reporter did not have lot number or any further details available at time of call.
Age: 72.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Ageusia, Dysgeusia
Clinical narrative: odd sensation in the mouth; bad taste; eventually loss of taste sensation; Initial information received on 08-Jan-2025 regarding an unsolicited valid  non-serious case received from a Patient.  This case involves a 72 years old male patient who experienced odd sensation in the mouth, bad taste and eventually loss of taste sensation after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 vaccine for Immunisation.  On 27-Oct-2024, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot UT8473DA, expiry: 30-Jun-2025, with unknown strength) via intramuscular route in unknown administration site as Immunization.  On an unknown date in NOV-2024, Approximately 1 or 2 weeks after vaccination the patient started with odd sensation in the mouth (paraesthesia oral) and more on taste and stuff, bad taste (dysgeusia) and eventually loss of taste sensation (ageusia).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Age: 72.0
Sex: M
Vaccine: FLU3, COVID19, FLU3
Symptoms: Ageusia
Clinical narrative: odd sensation in the mouth; bad taste; eventually loss of taste sensation; Initial information received on 08-Jan-2025 regarding an unsolicited valid  non-serious case received from a Patient.  This case involves a 72 years old male patient who experienced odd sensation in the mouth, bad taste and eventually loss of taste sensation after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 vaccine for Immunisation.  On 27-Oct-2024, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot UT8473DA, expiry: 30-Jun-2025, with unknown strength) via intramuscular route in unknown administration site as Immunization.  On an unknown date in NOV-2024, Approximately 1 or 2 weeks after vaccination the patient started with odd sensation in the mouth (paraesthesia oral) and more on taste and stuff, bad taste (dysgeusia) and eventually loss of taste sensation (ageusia).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Induration, Injection site pain, Injection site pruritus, Oedema peripheral
Clinical narrative: 9.5 cm localized reaction including redness, edema and induration of the right arm. Patient complained of pain at site and itching. Parent administered Tylenol and Zyrtec at the direction of the MD without much relief. Patient was evaluated in a face to face encounter later in the day. Determined to be a significant local reaction. MD reaching out to allergy for recommendations since this was the second time this child had a similar reaction to two different vaccines/
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Diaphragmalgia, Dyspnoea, Fatigue, Liver function test increased
Clinical narrative: Muscle pain, fever, chills, fatigue, hives on arm with pain and itching, pain in right rib and diaphragm area with difficulty taking deep breath. Lasted 3d.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Musculoskeletal chest pain, Myalgia, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Muscle pain, fever, chills, fatigue, hives on arm with pain and itching, pain in right rib and diaphragm area with difficulty taking deep breath. Lasted 3d.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Renal function test abnormal, Urticaria
Clinical narrative: Muscle pain, fever, chills, fatigue, hives on arm with pain and itching, pain in right rib and diaphragm area with difficulty taking deep breath. Lasted 3d.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient at the time of the vaccine administration on 1/8/2025 at Pharmacy 0424 already received the RSV vaccine at another pharmacy location in 2023. Per current guideline, RSV vaccine is one time dose vaccination. Thus, patient received an additional/inappropriate vaccine dose of the RSV vaccine.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Fatigue, Headache, Nausea
Clinical narrative: within an hour of vaccine, patient had sudden onset significant headache, nausea, vomiting, chills and fatigue/weakness. This improved with zofran, aleve, tylenol  and sleeping, and the fatigue slowly improved.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: within an hour of vaccine, patient had sudden onset significant headache, nausea, vomiting, chills and fatigue/weakness. This improved with zofran, aleve, tylenol  and sleeping, and the fatigue slowly improved.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 1 X 2 cm area of erythema, tenderness, and warmth
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Sensitive skin, Skin warm
Clinical narrative: Arm rash approximately 3 inches by 3 inches.  Area sore, hot, itchy, red, sensitive to touch.  Four days of symptoms, on fifth day symptoms present but reduced to mostly sore and hot.  Treated with antihistamine for itchiness.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Dizziness, sweating. Patient laid down with legs elevated. Resolved quickly.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Neuromuscular pain
Clinical narrative: General neuro-muscular pain starting in arms, extending to chest and back area, and involving hands
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Musculoskeletal stiffness, Neuromuscular pain
Clinical narrative: Neuro-muscular pain in back and sides extending to hands and fingertips; stiffness of back muscles and legs
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: I received an order for Shingrix #2 from Dr. I drew up diluent but did not combine with powder to form Shingrix vaccine. I administered diluent.  I then noticed the powder still in the second vial and realized I had only given diluent, not vaccine.  I called pt back to the room from the waiting area and explained the above, apologized. Pt stated understanding, accepted apology.  I then correctly prepared Shingrix vaccine and administered to pt.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Stroke #1 Apr 2024; Stroke #2 Aug 2024; Stroke #3 Nov 2024; death Nov 2024
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses on Arexvy vaccine on 2/7/24 and 12/30/24
Age: 70.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses  of the Arexvy (RSV) vaccine on 2/7/24 and 12/30/24.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: An Arexvy shot was given to the patient on 01/09/2025 while the patient already had 1 dose of Arexvy  in the past on 12/202023. Administer and patient were not aware that patient already had one dose, and patient came in based on doctor's recommendation
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature  excursion
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Cough and cold symptoms 6 weeks post vaccine. I don?t feel it is related to the vaccine, just the season and public exposure.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm is red, swollen and warm.  Advised her to get it checked by medical provider to rule out cellulitis.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Erythema, Fatigue, Mobility decreased, Pain
Clinical narrative: Tired, lightheaded, collapsed in hallway, can't sleep, excruciating pain, can't raise arm, red hot swollenness
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Skin warm, Sleep disorder, Swelling, Syncope
Clinical narrative: Tired, lightheaded, collapsed in hallway, can't sleep, excruciating pain, can't raise arm, red hot swollenness
Age: 21.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Hyperhidrosis, Nervousness, Pallor
Clinical narrative: Patient proceed to leave the facility, made it to the waiting room then had to sit down, became very shaky, sweating profusely and became pale. Brought patient back to the waiting room. Laid her down, ice pack, sucker for sugar intake. Stated she has POTS and this has happened before but not with vaccines. Is unsure if it was vaccine related or not. Patient laid there until she felt okay to leave and the provider checked back on her to make sure she was okay. Vitals were stable. Patient laid there for about 20 minutes until she left.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH
Age: 24.0
Sex: M
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pregnant patient. MD ordered Abrysvo and staff unintentionally administered Arexvy vaccine, which is contraindicated in pregnancy
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received an Arexvy vaccine on 3/23/24 with store.  He signed up for another on 1/6/25 and the 2nd dose was given. Due to guidelines this is outside of normal vaccine schedule/max number of doses.  We have called and left voicemail for patient to call back to verify side effects if any.
Age: 15.0
Sex: M
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: VIS was given to parent for review prior to vaccine administration. Informed parent and patient of common side effects. HPV9#1 was administred on LD. Patient was sitting down I administred HPV9  and a couple seconds after, patient started feeling dizzy and fainted. I had him inhale Amonia and at the same time PA was assessing patient. A few seconds after, patient recovered and was on observation for 15mins. After 15mins, patient was fully recovered and went home.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site reaction, Rash pruritic, Streptococcal infection
Clinical narrative: Bumpy/itchy rash developed 1 day after vaccination and rash/itching is limited to Left arm where vaccination was administered.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This is the second RSV Arexvy vaccine received by this patient. The initial dose was given 1/5/2024. Patient is reporting no issues and is feeling good.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Flushing, Hypoaesthesia oral, Throat irritation
Clinical narrative: Gave vaccine in right deltoid and within one minute bottom right side of lip went numb like Novocain was given then at minute 3 her upper right side lip when numb. Her face went flush and warm at minute 4 and throat was itchy. She does not have any breathing issue or throat swelling.  Vitals 105/75 HR 83 O296 temp 37.1- Took OTC Benadryl
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Received 2 injection on left tight 2 days ago. Yesterday woke up with redness and didn't want mom to touch her leg. This morning the redness is a little better, but still pain to touch and hot.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Bell's palsy, Facial paralysis, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Within 10 minutes of receiving the vaccine, the patient developed tongue numbness.  Over the course of the next 48 hours, his symptoms progressed into paresthesia and paralysis of the left side of his face which prompted him to go to the emergency department where he was diagnosed with Bells palsy.
Age: 34.0
Sex: M
Vaccine: TD, TD
Symptoms: Bell's palsy, Dry eye, Eye pruritus, Facial paralysis, Paraesthesia oral
Clinical narrative: Within 10 minutes of receiving the vaccine, the patient developed tongue numbness.  Over the course of the next 48 hours, his symptoms progressed into paresthesia and paralysis of the left side of his face which prompted him to go to the emergency department where he was diagnosed with Bells palsy.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Child received the the second flu vaccine 15 days after the first, too soon. No treatment was needed. Additional flu vaccine at the correct interval was required.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, TDAP, VARCEL
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Nurse administered Tdap to 5 year old,  then gave Dtap which was correct for age at same visit.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not viable due to temperature excursion
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temp excursion
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injury associated with device, Occupational exposure to product
Clinical narrative: Pharmacist  was capping the tip of the needle when she stuck her left index after administrating the shingrix vaccine into a pt. The entire shot was given to the pt but there may have been residue left on the tip that could have entered her finger.  Her finger was cleaned with alcohol and covered with a bandage. She was instructed by corp office to complete VAERS report.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temp excursion
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Urticaria
Clinical narrative: developed rash four hours after vaccine.  rash was increased the next day at school, saw school nurse, thought to be hives.  was given epipen by nurse.  other than rash no other sx.  no resp compromise.  was sent to ed for eval, diagnosed with urticaria.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Use by date was 12/29/30 and vaccine was administered on 12/30/24. Patient did not experience any unusual side effects to the dose.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient presented to vaccine clinic intended to receive boosters for bexsero and vatqa, however instead received seasonal influenza vaccine. Patient had not received this vaccine yet this season, and did not have allergy listed to it - also did not have any noted reaction. Patient informed of error and returned following day to receive correct boosters. No reactions noted so far.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Age: 11.0
Sex: M
Vaccine: DTAP, FLU3, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccines being administer as normal but Dtap was given instead of Tdap for the 11 year old patient. No adverse symptoms occured.
Age: 10.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 10 year old patient was given Dtap-IPV Kinrix instead of Dtap and IPV separated.  No adverse symptoms reported.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Antinuclear antibody negative, Arthralgia, Asthenia, C-reactive protein, Fatigue
Clinical narrative: Per call from pt to triage nurse at office 12/16/24: "Pt states she has been experiencing symptoms of chronic fatigue: no energy,  "can't function and want to sleep all day and night" for approx 3 weeks."  Per office visit 12/31/24: The patient reports having an adverse reaction to the pneumococcal vaccine (PCV20) approximately four weeks ago, manifesting as a large, hard, red, itchy lump at the injection site and diffuse, severe joint pain. The reaction persisted for over a month. It was also accompanied by severe fatigue that has persisted, although improved somewhat.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Rheumatoid factor negative, Somnolence
Clinical narrative: Per call from pt to triage nurse at office 12/16/24: "Pt states she has been experiencing symptoms of chronic fatigue: no energy,  "can't function and want to sleep all day and night" for approx 3 weeks."  Per office visit 12/31/24: The patient reports having an adverse reaction to the pneumococcal vaccine (PCV20) approximately four weeks ago, manifesting as a large, hard, red, itchy lump at the injection site and diffuse, severe joint pain. The reaction persisted for over a month. It was also accompanied by severe fatigue that has persisted, although improved somewhat.
Age: 16.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 16 year old patient was given PCV20 in place of Meningococcal B by mistake. No adverse symptoms occurred.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Vaccine deemed non viable due to temperature excursion
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Use by date was 12/29/24 and the vaccine was administered on 12/30/24. Patient did not experience any unusual side effects from dose.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal discomfort
Clinical narrative: pt remained in clinic the first 15 minutes with complications.  pt went to car and her throat started felling strange.  Pt drank some coffee to help with the feeling but the problem progressed.  pt returned to clinic to meet with RN who administered vaccine.  Rn walked pt straight to ER
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Vaccine deemed not stable due to temperature excursion
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT was given a dose of Quadracel for due doses of polio and Hib, this combo vaccine is intended for 4-6 year olds
Age: 54.0
Sex: F
Vaccine: FLU3, PNC20, VARZOS
Symptoms: Lip swelling, Pain, Urticaria
Clinical narrative: Developed painful full body hives, urticaria, and lip swelling within 48 hours.
Age: 55.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Injection site bruising, Injection site rash
Clinical narrative: Pt complained of nausea, vomiting, diarrhea, injections site rash and bruise. Migraine, chills, and anorexia for 2 days. She is improving, but she still has itching, a visible bruise at this moment.
Age: 55.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Migraine, Nausea, Pruritus, Vomiting
Clinical narrative: Pt complained of nausea, vomiting, diarrhea, injections site rash and bruise. Migraine, chills, and anorexia for 2 days. She is improving, but she still has itching, a visible bruise at this moment.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site mass
Clinical narrative: pt experienced post vaccination reaction keloid or bump-like at one of the injection sites (received both COVID-19 and FLU on the same arm on the same day). plans to follow up with a dermatologist.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received COVID-19 12y+ vaccine. instead of Meningoccocal ACWY vaccine
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions. Patient received vaccine early (due Dec 2025)
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Healthcare worker reported that a 2 year old patient received the second dose of VARIVAX earlier than recommended interval / The patient received first dose of VARIVAX (unknown lot) on 12/19/2023 and second dose on 1/2/2025 (y007637, 4/11/2026); No additional AEs were reported; This spontaneous report has been received from a health care professional, regarding a 2-year-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 19-DEC-2024, the patient was vaccinated with the first does of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, as prophylaxis (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported).  Then on 02-JAN-2025, earlier than recommended, it received the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection as prophylaxis as well (lot number: Y007637, which was determined to be valid, with an expiration date on 11-APR-2026) (strength, dose, route and anatomical location of administration, lot number and expiration date were not reported). (Inappropriate schedule of product administration).  The healthcare worker stated that the patient should have received the second dose between 4 to 6 years of age.  No adverse event nor additional information was provided.
Age: 84.0
Sex: F
Vaccine: PNC15, PNC21, PPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: bump/red mark on her arm from the vaccine/round mark on her arm after her pneumonia vaccine; bump/red mark on her arm from the vaccine/round mark on her arm after her pneumonia vaccine; This spontaneous report was received from  a consumer via other company concerning to herself a currently 84-year-old female patient.  The patient's medical history, historical drugs, known allergies, and further concurrent conditions were not reported. The patient's concurrent conditions included  dermatitis atopic. Concomitant medications included estradiol , losartan, apixaban (ELIQUIS), flecainide, clonazepam (KLONOPIN) and trimethoprim.   On 16-FEB-2021, the patient was started on therapy with dupilumab 300mg/2mL pre-filled syringe (also reported as solution for injection) 300 mg every other week (QOW), administered subcutaneously for atopic dermatitis-unspecified. On 11-NOV-2024 (reported as a week ago), the patient was vaccinated with the first dose of either pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, or pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection; administered in her arm (unspecified) for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided).  On an unknown date in November 2024, the patient experienced a slight reaction to it as she had a bump/red mark on her arm from the vaccine (also reported as round mark on her arm after her pneumonia vaccine) (Vaccination site lump) (Vaccination site erythema). It was not reported if the patient received a corrective treatment for the events, it was also confirmed tat there was no interaction between the suspect vaccines and dupilumab. The therapy with dupilumab was continued. At the time of reporting, the outcome of the events was unknown.   The reporter considered the events to be related to either of the suspect vaccines, but to be not related to dupilumab.   Lot # is being requested and will be submitted if received.  This is one of 2 reports received from the same reporter.  ; Sender's Comments:  US-009507513-2501USA000847:
Sex: U
Vaccine: PPV
Symptoms: Antibody test negative, Extra dose administered
Clinical narrative: not satisfied with their titer results stating the test is not showing immunity; No additional AE; This spontaneous report was received from a pharmacist referring to an adult patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, at a dose of 0.5 milliliter/series, administered for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).   On an unspecified date, the patient was not satisfied with their titer results stating the test did not showed immunity (antibody test negative); therefore, the pharmacist was ordered to re-vaccinate the patient. No additional adverse event was reported.  The outcome of the adverse event and the causal relationship between the event and the suspect vaccine was not reported.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 7 year old/ overage; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 05-NOV-2024, the patient received Kinrix. On 05-NOV-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 7 year old/ overage). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-DEC-2024 The registered nurse and HCP (health care professional) reported that a subsequent dose of Kinrix given to a 7-year-old patient, which led to an inappropriate age at vaccine administration. The HCP wanted to know if this was a valid dose or if there was anything else they need to do. No other products were received by the patients.
Sex: U
Vaccine: RSV
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Vomiting; Diarrhea; Nausea; This non-serious case was reported by a other health professional via sales rep and described the occurrence of vomiting in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In NOV-2024, the patient received Arexvy. In NOV-2024, less than a day after receiving Arexvy, the patient experienced vomiting (Verbatim: Vomiting), diarrhea (Verbatim: Diarrhea) and nausea (Verbatim: Nausea). The outcome of the vomiting, diarrhea and nausea were unknown.   The reporter considered the vomiting, diarrhea and nausea to be unrelated to Arexvy.   The company considered the vomiting, diarrhea and nausea to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 11-DEC-2024 The HCP (healthcare professional) reported that 20 patients of a nursing home received Arexvy about 2 weeks ago (from the date of reporting). That night, about 8-9 of these patients developed nausea, diarrhea, and vomiting. About 3 days later, other residents of the nursing home developed the same exact symptoms (nausea, diarrhea, and vomiting), but these residents did not receive the vaccine. The reporter believed the nausea, diarrhea, and vomiting experienced by the patients were not the result of the vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Therapeutic response unexpected
Clinical narrative: warts had completely disappeared/they were all gone; has been 11 months since her 1st dose, and she has not received the 2nd dose of Shingrix yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included plantar warts.   On an unknown date, the patient received the 2nd dose of Shingrix. On 11-JAN-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: warts had completely disappeared/they were all gone) and incomplete course of vaccination (Verbatim: has been 11 months since her 1st dose, and she has not received the 2nd dose of Shingrix yet). The outcome of the unexpected therapeutic effect and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt Date: 11-DEC-2024 Patient reports that she wanted to report that she received an additional benefit that she can only think was related to her Shingrix injection.  The patient reports that for 5 years she had been suffering with plantar warts and had multiple clusters of these on both feet. Patient reports that she had about 30 warts on both feet.  Patient reports, they were very painful and since March 2024 noticed they were not hurting anymore and had less of them.  Patient reports that by 4th July 2024, they had completely disappeared, which led unexpected therapeutic effect. The patient reports they were all gone.  Patient also reports that it has been 11 months since her 1st dose, and she has not received the 2nd dose of Shingrix yet, which led incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Shingrix about 8 months ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in April 2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix about 8 months ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-DEC-2024 The patient self-reported this case. He stated he received the first dose of Shingrix about 8 months ago in April 2024. He asks if he had to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Dose Late/First dose was administered on 24 July 2024 and Second dose was given on 12 December 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 25-year-old female patient who received HBV (Engerix B) (batch number YY37B, expiry date 24-AUG-2026) for prophylaxis.   Previously administered products included Engerix B (First dose received on 24 July 2024).   On 12-DEC-2024, the patient received the 2nd dose of Engerix B. On 12-DEC-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Second Dose Late/First dose was administered on 24 July 2024 and Second dose was given on 12 December 2024). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-DEC-2024 Pharmacist called regarding the hepatitis B vaccine, the vaccine Engerix. The doses schedule was supposed to be 0, 1 and 6 months.  The patient got her first dose on 24 July 2024. She had second dose 4 to 5 months later on 12 December 2024 which led to Drug dose administration interval too long. The patient received 2nd dose of Engerix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 10.0
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Nurse gave an expired dose of Boostrix to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 10-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number GH32J, expiry date 29-NOV-2024) for prophylaxis.   On 12-DEC-2024, the patient received Boostrix. On 12-DEC-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Nurse gave an expired dose of Boostrix to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-DEC-2024 Physician stated that her Nurse gave an expired dose of Boostrix to a patient on 12 December 2024 and vaccine expired back on 29 November 2024, which led to expired vaccine used. Doctor only had limited information at the time of reporting and they did not had initials or gender of the patient, but she gave consent to follow up.