chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the patient was under the required age for the vaccine.  The patient received a > then 12 yrs vaccine
Age: 1.25
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: When the vaccine was taken out, inadvertently an HPV vaccine was chosen instead of PCV20.  When administered it was noticed the color on the syringe and it was realized that the wrong vaccine was administered, a Gardasil vaccine to a 15-month-old child.
Age: 74.0
Sex: F
Vaccine: FLUA4, PNC20
Symptoms: Muscular weakness, Rash, Sensory loss
Clinical narrative: The patient is reporting a rash and lose of sensation of the RIGHT arm (weakness) approximately a day after receiving these vaccines. she has no known allergies.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reactions, but vaccine was administered too early as patient previously received his Menactra on 08/30/2023.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Blood bicarbonate normal, Blood calcium normal, Blood creatinine normal, Blood gases, Blood glucose normal
Clinical narrative: episode of limpness, not responding appropriately, cyanosis/pallor immediately after 2 mo vaccinations (also received PCV and oral rotavirus). 2-3 episodes occurred in the PCP office. Hospitalized for monitoring without recurrence of episodes.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Blood pH normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Chest X-ray normal
Clinical narrative: episode of limpness, not responding appropriately, cyanosis/pallor immediately after 2 mo vaccinations (also received PCV and oral rotavirus). 2-3 episodes occurred in the PCP office. Hospitalized for monitoring without recurrence of episodes.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Cyanosis, Electrocardiogram normal, Eosinophil percentage, Haemoglobin normal, Hyporesponsive to stimuli
Clinical narrative: episode of limpness, not responding appropriately, cyanosis/pallor immediately after 2 mo vaccinations (also received PCV and oral rotavirus). 2-3 episodes occurred in the PCP office. Hospitalized for monitoring without recurrence of episodes.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Hypotonia, Immediate post-injection reaction, Lymphocyte percentage increased, Mean cell volume normal, Pallor
Clinical narrative: episode of limpness, not responding appropriately, cyanosis/pallor immediately after 2 mo vaccinations (also received PCV and oral rotavirus). 2-3 episodes occurred in the PCP office. Hospitalized for monitoring without recurrence of episodes.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Platelet count normal, Red cell distribution width, Respiratory pathogen panel, White blood cell count increased
Clinical narrative: episode of limpness, not responding appropriately, cyanosis/pallor immediately after 2 mo vaccinations (also received PCV and oral rotavirus). 2-3 episodes occurred in the PCP office. Hospitalized for monitoring without recurrence of episodes.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Skin warm
Clinical narrative: Per PT:  "warm feelling spot that lasted 3 weeks"
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Blood alkaline phosphatase decreased, Headache, Magnetic resonance imaging head, Myalgia
Clinical narrative: Since June 2022 - ive had a headache, sore muscles around my neck and into my ears - ive also developed Hashimotos disease.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound thyroid
Clinical narrative: Since June 2022 - ive had a headache, sore muscles around my neck and into my ears - ive also developed Hashimotos disease.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Needle issue
Clinical narrative: Upon reconstitution, the luer-lock adapter dislodged from the syringe. This has taken place several times this month by several providers, despite great care when reconstituting. All have been from the same lot, upon further investigation. This was Lot # HM9849, Exp 3/2025 for the vial and Lot# HG1756, Exp 5/2025 for the syringe.
Age: 0.83
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Ear infection, Rash
Clinical narrative: Patient was seen at 8am for a Well Exam with Vaccines. Per mom after they left they went to eat and pt had a small amount of eggs, that was around 10am. At noon mom noticed that pt has rash all over body. Pt was taken to ER and was treated with Benadryl and given antibiotics for a double ear infection.
Age: 12.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Diet refusal, Fatigue, Gait disturbance, Headache, Myalgia
Clinical narrative: Muscle pain all over, headache, tiredness. Hard to walk, won't eat.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Costochondritis, Muscle spasms, Neuralgia
Clinical narrative: Intense nerve pain on my left side, from the neck to the arm to the ribs...Occasional burning sensation and muscle spasms in the same area...
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: ADDTIONAL DOSE OF MMR WAS GIVEN
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 11.0
Sex: M
Vaccine: DTPPVHBHPB, HEP, HEPA, HPV9, MNQ
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given Vaxelis out of age range as well as a double dose of Hep B.  No symptoms noted.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: ADDITIONAL MMR VACCINE WAS GIVEN
Age: 55.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse reactions noted. Pt received a vaccine that was only for ages 4-6.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult Hep A was given instead of Ped Hep A  dose. No treatment needed. Patient stayed 15 minutes in the clinic without any side effect.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse effects to the patient.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event
Clinical narrative: there were no adverse effects.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: RED, Swelling, warm
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Cough, Dyspnoea, Erythema, Loss of consciousness, Rash macular
Clinical narrative: Patinet mother notified clinic of daughter passing out since living the clinic. Contacted us at 308pm. Spoke to pt's mother and she stated that pt got and cough , face turned red and splotchy and face swelling , sob. Pt has gone to ER. Evaluated in ER NRH 8/13/24 for SHOB. Upon arrival patinet was nontoix and prescribed solumedrol, pepcid and benadryl for symptoms control.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Swelling face
Clinical narrative: Patinet mother notified clinic of daughter passing out since living the clinic. Contacted us at 308pm. Spoke to pt's mother and she stated that pt got and cough , face turned red and splotchy and face swelling , sob. Pt has gone to ER. Evaluated in ER NRH 8/13/24 for SHOB. Upon arrival patinet was nontoix and prescribed solumedrol, pepcid and benadryl for symptoms control.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient was here with pregnant daughter. At our clinic we offer partner/caregiver vaccines for whoever will be taking care of the baby. I offered Tdap and Covid to the patient, patient stated she had the updated covid vaccine but needed her Tdap. I gave patient her Tdap and went to enter it in and realized she had already had her Tdap on 4/5/2024.
Age: 65.0
Sex: M
Vaccine: RSV, TDAP, VARZOS, VARZOS
Symptoms: Back pain, Herpes zoster, Pain in extremity, Rash vesicular
Clinical narrative: Shingles  Symptoms and physical examination findings are consistent with shingles, including a blistery rash down the nerve and pain in the affected areas. He reports significant pain, especially in the palm of his hand and back. A prescription for Valtrex 1 g three times daily has been provided. He was informed that the condition is contagious and can potentially lead to chickenpox in individuals who have not previously contracted it. He was advised to report this adverse reaction to the pharmacy where he received his shingles vaccine. If the pain intensifies, he should inform the clinic so that a steroid or pain medication can be prescribed. The potential for postherpetic neuralgia was discussed, and the importance of starting antiviral treatment promptly was emphasized.
Age: 65.0
Sex: M
Vaccine: RSV, TDAP, VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Injection site reaction, Pruritus
Clinical narrative: Shingles  Symptoms and physical examination findings are consistent with shingles, including a blistery rash down the nerve and pain in the affected areas. He reports significant pain, especially in the palm of his hand and back. A prescription for Valtrex 1 g three times daily has been provided. He was informed that the condition is contagious and can potentially lead to chickenpox in individuals who have not previously contracted it. He was advised to report this adverse reaction to the pharmacy where he received his shingles vaccine. If the pain intensifies, he should inform the clinic so that a steroid or pain medication can be prescribed. The potential for postherpetic neuralgia was discussed, and the importance of starting antiviral treatment promptly was emphasized.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given an expired vaccination. Expiration date on box was used instead of green sticker date. Pt has not had any adverse reactions at this time.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Infant irritability, Lethargy, Pyrexia, Skin swelling
Clinical narrative: Patient was in office for a 15 month physical date of service 05/16/2024. Mother states no symptoms time of vaccination given , however she states she did notice hives on both legs and both arms 05/17/2024 12:00pm  from the vaccines raised redness does not remember warm to touch. Patient was fussy, lethargic, fever evening 103 and 05/18/2024 am 100. Gave  Benadryl and Tylenol Treatment plan hives cleared patient is feeling better no other reactions since the date of service. Mom followed up with Dr. in office to look out for anything abnormal  and touch bases if proceeds.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Patient was in office for a 15 month physical date of service 05/16/2024. Mother states no symptoms time of vaccination given , however she states she did notice hives on both legs and both arms 05/17/2024 12:00pm  from the vaccines raised redness does not remember warm to touch. Patient was fussy, lethargic, fever evening 103 and 05/18/2024 am 100. Gave  Benadryl and Tylenol Treatment plan hives cleared patient is feeling better no other reactions since the date of service. Mom followed up with Dr. in office to look out for anything abnormal  and touch bases if proceeds.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash, Malaise, Rash
Clinical narrative: Rash later day of injection and next day at site and on legs.   Mother stated that the patient didn't feel well.   Mother administered Benadryl.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Laboratory test, Mobility decreased, Neck pain
Clinical narrative: Within days I had tachycardia upon standing, dizziness, difficulty walking straight, neck pain, and neuropathic pain.  It continued to progress. Now at this point I am 80% bedridden.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Tachycardia
Clinical narrative: Within days I had tachycardia upon standing, dizziness, difficulty walking straight, neck pain, and neuropathic pain.  It continued to progress. Now at this point I am 80% bedridden.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Patient received MMR vaccine on 8/5/24 and presented on 8/20/24 with small red spots, some of which are slightly raised on torso and back. Denies fever, cough/ congestion, sore throat, ear pain, decreased appetite, n/v/d. Denies sick symptoms in the last 2 weeks. No treatment is needed. Rash should fade over the next few days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain in extremity, Rash, Rash pruritic
Clinical narrative: She got her vaccine, she had the arm pain, it is red and hurt.  Then about 2 weeks later she got what she originally thought was a spider bite.  She had a patch about the size of a quarter.  She has 4 of those patches and they had 1 or 2 had at least little bumps that came up on her.  They were very itchy, they hurt and they burned.  First she got 2 and then she got 2 more over the last 2 weeks.  The last one was on the side of her breast, near the nipple which was very painful and burned.  Then it dawned on her that it was not possibly a spider bite but maybe a reaction to the vaccine.  She had chicken pox when she was a kid, and it almost felt like maybe she had chicken pox and possibly shingles as it itched, and the bumps when you get pox.  The pain alerted her mind that maybe it was the vaccine as you don't usually get the burning pain with a bug bite.  She is seeing her doctor today.  She was using Benadryl cream and took a Benadryl tablet and it finally stopped hurting.  The red patches from 2 weeks ago from the front of her chest are still there, but they do not itchy anymore.   She wants to know if she should get the 2nd shot or not.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Heart rate increased, Tachycardia
Clinical narrative: After shot got sick to stomach.  By Friday had a fast heart rate, tachycardia 132 and bp was 175/100.  Couldn't catch my breath or talk. Taken by ambulance to ER.
Age: 0.75
Sex: M
Vaccine: MMR, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMR given off schedule due to parent request and recent outbreak in are where patient lives.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented with redness, heat, swelling, and pain at the injection site of right arm. This spread upwards above her shoulder joint, and down past her elbow. She was treated at the hospital with IV antibiotics and sent home with oral Bactrim DS.
Age: 74.0
Sex: F
Vaccine: FLU4, PNC20, RSV, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt presented with redness, heat, swelling, and pain at the injection site of right arm. This spread upwards above her shoulder joint, and down past her elbow. She was treated at the hospital with IV antibiotics and sent home with oral Bactrim DS.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Pyrexia, Seizure
Clinical narrative: Injection site reaction, fever, convulsions
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, SARS-CoV-2 test
Clinical narrative: Cough, fatigue
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Loss of consciousness, Seizure like phenomena
Clinical narrative: Ten minutes after Tdap administration, patient lost consciousness and showed seizure-like activity (arms and legs jerking).  BP 133/88 during event.  Ice packs were placed on the patient for 30 minutes.  Patient was monitored until family member was able to pick her up from the clinic.
Age: 14.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given a shingrix vaccine instead of meningococcal vaccine.  No adverse effects reported from the patient.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Reports pain in right deltoid that radiates up arm and has a swollen lump at the injection site
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered outside the timeframe recommended by the manufacturer.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: patient had an adverse reaction to TDAP vaccine on 08/31/2007. Patient agreed to having TDAP injection when asked by provider and nurse. Patient did not have any concerns of a possible reaction when patient came back to speak with office around 20 minutes after vaccine was given. Patient was informed to call office with any adverse reaction.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: MD placed order for VFC 25 mcg/0.25 mL dose of the covid 19 vaccine around 0845.  Nurse administer the covid vaccine available in our VFC freezer. After the vaccine was administered nurse attempted to document administration of vaccine, but was unable to do so due to issues with the lot number of the vaccine not matching the order. It was at this time that it was noted that patient was given 50 mcg/0.50mL dose instead of the correct dose ordered. Once MD and clinic management were made aware of the mistake, mother was notified via phone of the mistake that occurred, and was educated on what to monitor for and when to bring patient in to be evaluated. Mother expressed understanding. She reported possible fever as only symptom
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered outside the timeframe recommended by the manufacturer.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Electroencephalogram normal, Hypotonia, Posture abnormal
Clinical narrative: Episodes of head dropping while sitting began very soon (same day) after receiving the third dose of rotavirus vaccine, according to the patient's parents. He has had problems with hypotonia and concerns about developmental delay since then. The patient's parents are concerned that those long-term problems were related to the rotavirus vaccine because of the timing. Please note that this report is provided approximately three years after the onset.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered outside the timeframe recommended by the manufacturer.
Age: 40.0
Sex: M
Vaccine: COVID19, FLU4, TDAP
Symptoms: No adverse event
Clinical narrative: No adverse effects
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Oropharyngeal pain, Swelling face, Urticaria
Clinical narrative: Patient received routine vaccines in clinic without difficulty. Mother called clinic approximately 30 minutes after vaccination to report child was being evaluated at ER for facial swelling, throat pain, and hives. Received Epi-pen Jr IM at 15:52p, Decadron IM at 15:59p, and Benadryl IM at 16:02p while in ER. Patient stable after medications. Diagnosed with allergic reaction and discharged home with oral Prednisolone x 2 days.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse sfx
Age: 24.0
Sex: M
Vaccine: HEPA, HPV9, TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse events occurred. Hepatitis A vaccine was administered too early according to schedule. It was  due on 12/05/2024-dose#1 was administered on 06/05/2024. Dose#2 was given inadvertently on 08/12/2024.
Age: 14.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient received meningococcal B vaccine instead of Men A as ordered. (Pt did receive Men A vaccine once error was noted)
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse sfx
Age: 67.0
Sex: M
Vaccine: FLUC4
Symptoms: Wrong product administered
Clinical narrative: Patient was administered Flucelvax instead of Fluad. Patient is over 65 years old and should have received Fluad.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reported adverse sfx
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered outside the timeframe recommended by the manufacturer
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reported adverse SFX
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered outside the timeframe recommended by the manufacturer
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: none
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Discomfort, Gait disturbance, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: I had a fever about a week and a half after which was normal, lasted about three days. Starting on August 18th started to get stiff and painful knee joints and now both knees and my right wrist are so painful and stiff that it is difficult, uncomfortable and painful to walk and still is today the 20th.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia
Clinical narrative: I had a fever about a week and a half after which was normal, lasted about three days. Starting on August 18th started to get stiff and painful knee joints and now both knees and my right wrist are so painful and stiff that it is difficult, uncomfortable and painful to walk and still is today the 20th.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No advers sfx
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Client was given adult dose of Hep A when he should have gotten a pediatric dose due to his age. Client did not report any adverse reactions or require treatment to our knowledge.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse reaction, or outcome.
Age: 77.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: No adverse event
Clinical narrative: No reported adverse sfx
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered outside the timeframe recommended by the manufacturer
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: PATIENT EXPERIENCED PAINFUL INJECTION AND HAS HAD PERSISTENT ARM PAIN SINCE THEN (~8 MONTHS). PATIENT NOTIFIED THE PHARMACY TODAY WHILE GETTING ANOTHER VACCINATION.
Age: 16.0
Sex: M
Vaccine: COVID19, FLU4, MNQ
Symptoms: No adverse event
Clinical narrative: No reported adverse sfx
Age: 14.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: No adverse event
Clinical narrative: No reported adverse SFX
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reported adverse sfx
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Injection site erythema, Injection site pruritus, Swelling
Clinical narrative: Reported redness, swelling, headache on 8/18/2024 and Itchy and redness at injection site on 8/20/2024 .Onset of symptoms 2 days post injection (8/18/2024).
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Injection site pain, Screaming, Tension
Clinical narrative: Patient requested multiple vaccines to be administered. Confirmed with patient that she had been instructed by physician to receive all her vaccines at the same time. Began 1st injection and patient jolted, tensed up and yelled. She was asked if she was ok. Patient said that she could feel the shot and it hurt very bad.  The injection site and surrounding areas did not look irritated or inflamed. Patient stayed in pharmacy waiting area and then went to get her husband. Patient did not get other vaccines, decided to wait.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reported  adverse SFX
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Cardiomyopathy, Computerised tomogram heart, Echocardiogram, Electrocardiogram
Clinical narrative: PFIZER #1 3/1/2021 PFIZER #2 3/19/2021 DEVELOPED VACCINE INDUCED SUBCLINICAL MYOCARDITIS AND NONISCHEMIC CARDIOMYPATHY AND ATYPICAL PARKINSONS DISEASE.  TREATED WITH ENTRESTO, COLCHICINE, COREG, AND  BASE SPIKE DETOXIFICATION.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction, Parkinson's disease
Clinical narrative: PFIZER #1 3/1/2021 PFIZER #2 3/19/2021 DEVELOPED VACCINE INDUCED SUBCLINICAL MYOCARDITIS AND NONISCHEMIC CARDIOMYPATHY AND ATYPICAL PARKINSONS DISEASE.  TREATED WITH ENTRESTO, COLCHICINE, COREG, AND  BASE SPIKE DETOXIFICATION.
Age: 1.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Wrong product administered
Clinical narrative: Dr. was able to call the mother again just a few minutes ago and informed her about the wrong vaccine given to patient and expressed our apology for the incident and that we had already talked to the MA about the incident.  Dr. told her to let me know how I can help . The mother thanked Dr. for the call. Mother of child would not elaborate about any symptoms to Dr.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: None stated.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine administered outside the timeframe recommended by the manufacturer
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dreamy state, Loss of consciousness, Syncope, Tearfulness
Clinical narrative: Patient presented to office for routine vaccination. Paperwork was completed and patient denied on the form and verbally any previous reactions to vaccines or that the patient was feeling unwell. Prior to vaccination, patient denied having any questions or concerns for nurse. Patient received her second dose of Meningococcal ACWY vaccine and her first dose of both Meningococcal B and HPV9. Patient tolerated vaccine administration well. Following vaccine administration, patient ambulated to the lobby without difficulty and had a seat in one of the chairs in the waiting room. Approximately 1 minute later, front desk staff called for nurse, stating that the patient had "passed out." Nurse found patient slouched in the chair with her eyes closed. Nurse slid the patient out of the chair into a lying position on the floor. Nurse requested that front desk staff obtain the first aid kit as she remained with the patient. Nurse attempted to rouse the patient by calling her name and shaking her slightly, at which time the patient regained consciousness. Nurse obtained vital signs at this time to be: HR = 122 bpm, BP = 142/88 mmHg, Respirations = 26, and SpO2 = 98% RA. At this time, patient became tearful and asked what had happened. Nurse explained that patient had came to the waiting room following administration and had fainted while sitting in the chair. The nurse reassured patient that she was safe and that we will continue to monitor her. Patient was given a glass of water and began to calm down. Vital signs were reassessed at this time, approximately 1619, to be: HR = 98 bpm, BP = 124/66 mmHg, Respirations = 20, and SpO2 = 97% RA. Patient was then able to get up from the floor and sit in a chair. Patient continued to drink water and ate 2 cookies. Upon being asked if she noticed feeling any symptoms, patient denied this, stating, "It just felt like I was dreaming, and then all of a sudden I wake up and I'm on the floor with you there. But I feel fine now." Patient remained sitting for a few more minutes, and then ambulated with nurse out of the office without difficulty. Nurse advised patient of ER precautions should symptoms arise. Patient verbalized understanding and agreement.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No reported adverse sfx
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash
Clinical narrative: Rash anterior neck.  temp of 100.1
Age: 0.17
Sex: M
Vaccine: PNC15, RV1, VARCEL
Symptoms: Wrong product administered
Clinical narrative: When the MA was entering the vaccine information for the injection that was given, she noted that the vaccine information was not matching the order.  The provider asked the MA what vaccine she is trying to put in and she stated Varivax. The provider informed MA that was the wrong vaccine given and it was supposed to be Vaxelis instead.  The provider notified the writer and the patient guardian.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: No reported adverse sfx
Age: 77.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: No adverse event
Clinical narrative: No adverse sfx reported
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Herpes zoster, Rash
Clinical narrative: Red rash on L side of neck and R forearm appeared on 07/12/2024 @ 9 AM; Saw Dr. on 07/15/2024 for treatment; Dx. Shingles with treatment on Valacyclovir; Treatment successful
Age: 0.17
Sex: M
Vaccine: PNC20, RV1, VARCEL, VARCEL
Symptoms: Wrong product administered
Clinical narrative: When the MA was entering the vaccine information for the injection that was given, she noted that the vaccine information was not matching the order the provider had placed.  The provider asked the MA what vaccine information she is trying to put in and she should the provider the bottle and name which was Varivax. The provider informed the MA that she gave the wrong injection and vaccine to patient. The provider stated it was supposed to be Vaxelis. The provider then notified writer and the patient Guardian.
Age: 0.17
Sex: M
Vaccine: PNC20, RV1, VARCEL, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: When the MA was entering the vaccine information for the injection that was given, she noted that the vaccine information was not matching the order the provider had placed.  The provider asked the MA what vaccine information she is trying to put in and she should the provider the bottle and name which was Varivax. The provider informed the MA that she gave the wrong injection and vaccine to patient. The provider stated it was supposed to be Vaxelis. The provider then notified writer and the patient Guardian.
Age: 77.0
Sex: M
Vaccine: COVID19, TD
Symptoms: No adverse event
Clinical narrative: No reported adverse sfx
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: Patient started to develop warts on arm after 1st dose of Gardasil 9 given on August 4th of 2023. The warts developed sometime after the 1st dose given.; This spontaneous report was received from a physician and refers to a 14-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-AUG-2023, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly for prophylaxis (strength, dose, lot #, and expiry date were not provided).  On an unspecified date in August 2024, after the first dose, the patient started to develop warts on arm (skin papilloma).  At the time of reporting, the outcome of the was unknown. The action taken with the suspect vaccine regarding the event was not applicable.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Additional AE; patient received ROTATEQ after its labeled expiration date (05/24/2024); This spontaneous report was received from Other Health Professional and refers to a 6-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUN-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1947642 (which has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ)), expiration date: 26-MAY-2024 (strength, route of administration, and indication were not provided) after the labeled expiration date (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; 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) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 15-AUG-2024 This case was reported by a patient via interactive digital media. The reporter state that everyone he/she knew who got the Shingles vaccine still got the shingles. The reporter stated that do not take any vaccines as they were all bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Radiation associated pain, Skin injury
Clinical narrative: Severe pain in area of previous radiation treatment for breast cancer; radiation caused the most damage to my skin; This non-serious case was reported by a consumer and described the occurrence of pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and radiation therapy (previous radiation treatment for breast cancer).   On 10-AUG-2024, the patient received Shingrix. On 11-AUG-2024, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: Severe pain in area of previous radiation treatment for breast cancer). In AUG-2024, the patient experienced skin damage (Verbatim: radiation caused the most damage to my skin). The outcome of the pain was not resolved and the outcome of the skin damage was not reported.   It was unknown if the reporter considered the pain and skin damage to be related to Shingrix.     It was unknown if the company considered the pain and skin damage to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-AUG-2024 This report was submitted via the online direct entry reporting system. The patient was also the reporter. The patient really wanted to know if this was a possible side effect. The pain was constant and in the area where the radiation caused the most damage to skin. The patient had severe pain in area of previous radiation treatment for breast cancer. The symptoms were not treated.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: he had pain in vaccinated arm for 2-3 days; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: he had pain in vaccinated arm for 2-3 days). The outcome of the pain in arm was resolved.   The reporter considered the pain in arm to be related to Shingrix.     The company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-AUG-2024 The physician reported that the patient had pain in vaccinated arm for 2 to 3 days, but that resolved. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Muscle disorder, Neck pain
Clinical narrative: Neck pain; reaction of muscle; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of neck pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypoxemia and heart disease pulmonary.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced neck pain (Verbatim: Neck pain) and muscle disorder (Verbatim: reaction of muscle). The outcome of the neck pain and muscle disorder were unknown.   It was unknown if the reporter considered the neck pain and muscle disorder to be related to Shingrix.     It was unknown if the company considered the neck pain and muscle disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-AUG-2024 The healthcare professional reported that the patient started therapy with Shingrix vaccine and experienced reaction of muscle and neck pain.
Sex: U
Vaccine: PPV, RVX
Symptoms: Influenza like illness, Malaise
Clinical narrative: flu-like symptoms; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Pneumococcal vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and Pneumococcal vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms) and sickness (Verbatim: sick). The outcome of the influenza-like symptoms and sickness were resolved (duration 3 days).   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to RSV vaccine.     It was unknown if the company considered the influenza-like symptoms and sickness to be related to RSV vaccine.   Additional Information: GSK receipt date: 10-AUG-2024 This case was reported the patient via interactive digital media. The patient had RSV and pneumonia shot at the same time and was sick with flu-like symptoms for 3 days. It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to pneumonia shot.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Immediate post-injection reaction, Rosacea
Clinical narrative: rosacea and he had a flare up immediateltly; This non-serious case was reported by a physician via sales rep and described the occurrence of rosacea aggravated in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rosacea. Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced rosacea aggravated (Verbatim: rosacea and he had a flare up immediateltly). The outcome of the rosacea aggravated was not reported.   The reporter considered the rosacea aggravated to be related to Shingrix.     The company considered the rosacea aggravated to be related to Shingrix.   Additional Information: GSK receipt date: 13-AUG-2024 The patient had history of rosacea and he had a flare up immediately after Shingrix vaccination. He also had diabetes. Patient believed it was related to vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Needle issue, Underdose
Clinical narrative: vaccine exposure during administration; vaccine exposure during administration; vaccine exposure during administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while administering product 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 occupational exposure while administering product (Verbatim: vaccine exposure during administration), exposure via skin contact (Verbatim: vaccine exposure during administration) and inadvertent exposure to vaccine (Verbatim: vaccine exposure during administration). The outcome of the occupational exposure while administering product, exposure via skin contact and inadvertent exposure to vaccine were not reported.   Additional Information: GSK receipt date: 06-AUG-2024 It was reported that during injection the needle popped off and most of the vaccine was spilled on the patient and the Medical assistant administering it which led to, exposure via skin contact and inadvertent exposure to vaccine. The reporter was just wondering if they could get credit for one vial of Shingrix. Since they were unsure how much of the vaccine received would it be better to had the patient come back in 2 months and get a second vaccine and then in another 2 months to receive a full dose so that she would have 2 to 1/2 doses. The case is linked with US2024AMR098294, same reporter.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product complaint
Clinical narrative: Pharmaceutical product complaint; received Menveo 2 vials presentation second dose but it was not a full dose/majority of the the vaccine was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA989A, expiry date 31-DEC-2025) for prophylaxis.   On 07-AUG-2024, the patient received the 2nd dose of Menveo. On 07-AUG-2024, an unknown time after receiving Menveo, the patient experienced incomplete dose administered (Verbatim: received Menveo 2 vials presentation second dose but it was not a full dose/majority of the the vaccine was administered). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 07-AUG-2024 The physician assistant reported that the patient received 2nd dose of Menveo 2 vials presentation but it was not a full dose and looked like the majority of the vaccine was administered to the patient, which led to incomplete dose administered. When the nurse drawn up the vaccine, administered it and everything and the needle was retracted and there was an small amount of vaccine inside.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Patient received the liquid portion only of Shingrix vaccine; Patient received the liquid portion only of Shingrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-AUG-2024, the patient received Shingrix. On 08-AUG-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient received the liquid portion only of Shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: Patient received the liquid portion only of Shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-AUG-2024 The healthcare professional reported that the patient received only the liquid portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consent to follow up.
Sex: U
Vaccine: HEP, MENB
Symptoms: Product storage error
Clinical narrative: Inadvertent Administration of Engerix-B peds and Bexsero after being expose to freezing temperatures; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Bexsero. On an unknown date, an unknown time after receiving Engerix B pediatric and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Inadvertent Administration of Engerix-B peds and Bexsero after being expose to freezing temperatures). The outcome of the incorrect storage of drug 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-AUG-2024 Office Manager reported the following temperature excursion of vaccines of Engerix-B peds and Bexsero lowest temperature 31.8 degree Fahrenheit for time: 1 hr and 15 minutes. No other excursions.  The health care professional (HCP) was not sure about possible administration of these vaccines after Jun 22nd 2024 to patients. Inadvertent Administration of Engerix-B peds and Bexsero after being expose to freezing temperatures, which led to incorrect storage of drug. Consented to follow up.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Product administered at inappropriate site
Clinical narrative: Inappropriate Dose Administration Site (Pediatric Patient); This non-serious case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 6-month-old male patient who received HBV (Engerix B) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis.   On 13-AUG-2024, the patient received Engerix B (unknown deltoid). On 13-AUG-2024, an unknown time after receiving Engerix B, the patient experienced vaccine administered at inappropriate site (Verbatim: Inappropriate Dose Administration Site (Pediatric Patient)). The outcome of the vaccine administered at inappropriate site 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-Aug-2024 The reporter was a medical assistant. The reporter called to ask question regarding safety information or advise about an inappropriate dose administration site as dose administered in the deltoid region instead of anterolateral aspect of the thigh in a male 6 month year old patient, which led to vaccine administered at inappropriate site. The patient demographics and vaccine detail requested and documented in the proper sections.  No further detail was provided from the medical assistant's end. The vaccine administration facility was the same as primary reporter.