chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have them now and not an easy case; I have them now and not an easy case; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have them now and not an easy case) (serious criteria GSK medically significant) and shingles (Verbatim: I have them now and not an easy case). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date:02-JUL-2025 This case was reported by a patient via interactive digital media. The patient had them (shingles) now and it's not an easy case .  The patient had both vaccines. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; patient inadvertently received expired dose of VAQTA; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 01-Jul-2025, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #X023975, expiration date: 18-Apr-2025), administered for prophylaxis (strength, dose, and route were not reported) (Expired product administered). There was no temperature excursion. Dose was supported per post expiry memo. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: accidentally could have administered only the adjuvant portion of Shingrix; accidentally could have administered only the adjuvant portion of Shingrix; 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 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally could have administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: accidentally could have administered only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 18-JUN-2025 A nurse called to report that they might have accidentally administered only the adjuvant portion of the Shingrix vaccine to 1 out of 7 patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This had been the first dose of Shingrix for all seven patients. The reporter asked that they do have to revaccinate all the 7 patients involved in this possible administration of the adjuvant only. This is 4 out of 7 linked patients reported by the same reporter.; Sender's Comments:  US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: adult female patient received Arexvy adjuvant alone without the powder; adult female patient received Arexvy adjuvant alone without the powder; 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 81-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number P7FJ2, expiry date 30-NOV-2025) for prophylaxis.   On 28-JUN-2025, the patient received Arexvy. On 28-JUN-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: adult female patient received Arexvy adjuvant alone without the powder) and inappropriate dose of vaccine administered (Verbatim: adult female patient received Arexvy adjuvant alone without the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 30-JUN-2025 Clinical director wanted to see if they need to revaccinate because the patient received Arexvy adjuvant alone without the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Age: 33.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Lip swelling, Peripheral swelling, Rash, Urticaria
Clinical narrative: Client received 2 Vaccines: Tdap 0.5 ml and Prevnar 20 0.5 ml intramuscular injection to left deltoid on 6/20/25. Client called on 6/23/25 stated at 6:00 PM on 6/20/25, she has hives, rashes all over her face, chest and arms. Client reported rashes were more pronounced on 6/21/25 and 6/22/25. On 6/23/25, her lips and legs started swelling and she called the clinic. Client denies taking any new medication or any new foods, drinks or use of new detergent. Dr. was notified and advised client to Clartin in the day time and Benadryl at night. She was advised to contact her provider or go to Urgent care if her breathing is affected or if symptoms get worse. Client verbalized understanding. Client was called on 6/24/25 regarding symptoms and client reported they had resolved.
Age: 50.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Cellulitis, Ear pain, Ear swelling, Pyrexia
Clinical narrative: Fever, severe ear pain & swelling. Diagnosed with cellulitis at urgent care. Prescribed doxycycline and triamcinolone cream (7/5/25). Office visit 7/7/25 - showed improvement.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Angioedema
Clinical narrative: facial angioedema pt was given epi pen (prn), steroids & benadryl to help w/swelling. ER note is attached & patients chart has been flagged.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Somnolence, Urticaria
Clinical narrative: Parent reports child was more sleepy after the vaccine and >24hrs later developed hives on the trunk which progressed to thigh.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Confirmed no symptomatic adverse events at this time; one dose of GARDASIL-9 in the summer of 2024 and another dose on 27- JUN-2025.; This spontaneous report was received from a nurse concerning a 35-year-old female patient.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. The patient received 3 doses of HPV vaccine VLP rL1 4v (yeast) (GARDASIL) as a teenager.  On approximately 20-Jun-2024 (reported as "in the summer of 2024"), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form (route of administration, anatomical location, bath/lot # and expiration date were not reported). On 27-Jun-2025, the patient was vaccinated by a health professional with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe, batch/lot #Y015180 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation confirmed as 28-Jan-2027, 0.5 mL (anatomical location and route of administration were not reported) (inappropriate schedule of product administration). Both vaccine doses were administered a prophylaxis  Confirmed no symptomatic adverse events at this time (no adverse event.)  Batch/lot# is being requested and will be submitted if received.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: titer test showed zero immunity again; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received MMR (Priorix) for prophylaxis.   Previously administered products included MMR vaccine (received in 1963) and MMR (received in 1983). Concurrent medical conditions included mast cell activation syndrome (Consumer states she has mast cell activation syndrome and is injected with IgE.  Consumer states her last vaccination with IgE was 15 APR 2025). Concomitant products included Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr).   On 25-APR-2025, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: titer test showed zero immunity again). The outcome of the therapy non-responder was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt Date: 20-JUN-2025 Consumer states she has mast cell activation syndrome and is injected with IgE.  Consumer states her last vaccination with IgE was 15 APR 2025  The reporter states that she was vaccinated with an MMR vaccine in 1963 and in 1983 (unknown name and specific dates.)  Consumer states she had a titer test for MMR and the results noted zero immunity.  The consumer states she was vaccinated again with an MMR vaccine on 27 APR 2025 and titer test showed zero immunity again (lack of effect.)  Consumer could not provide the lot number for the vaccine, however, she was able to provide an national drug code number.  The national drug code number she provided was for an MMR vaccine manufactured by MERCK SHARP and DOHME.  Consumer was unable to verify having received an MMR vaccine manufactured by GSK, however, she states she thought she did receive an MMR vaccine manufactured by GSK.  Consumer will follow up with safety to cancel case or call GSK to cancel case if she finds she did not receive MMR vaccine manufactured by GSK.  Consumer states she has a lot going on and she may have gotten confused after having had an endoscopy (date not disclosed) and medication associated with that procedure.  Consumer also states she will be a participant in a clinical trial for an antiviral (undisclosed diagnosis) starting soon.  No further information was provided/obtained.  Its not indicated for adults.  Consumer calls back to cancel this report.  She received an MMR vaccine manufactured by another pharmaceutical company (MSD.)
Vaccine: RSV
Symptoms: Dyspnoea, Eye swelling, Lacrimation increased
Clinical narrative: Can not breath; my eyes are swollen and teary; my eyes are swollen and teary; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced difficulty breathing (Verbatim: Can not breath), eye swelling (Verbatim: my eyes are swollen and teary) and eyes tearing (Verbatim: my eyes are swollen and teary). The outcome of the difficulty breathing, eye swelling and eyes tearing were not reported.   It was unknown if the reporter considered the difficulty breathing, eye swelling and eyes tearing to be related to Arexvy.     It was unknown if the company considered the difficulty breathing, eye swelling and eyes tearing to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-JUN-2025 The patient reporter after receiving Arexvy vaccine, could not breath, all stuffed op, eyes were swollen and teary.
Vaccine: RSV
Symptoms: Injection site pruritus
Clinical narrative: Itching at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site itching (Verbatim: Itching at injection site). The outcome of the injection site itching was not reported.   It was unknown if the reporter considered the injection site itching to be related to Arexvy.     It was unknown if the company considered the injection site itching to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-JUN-2025 This case was reported by a patient via interactive digital media. The patient received the Arexvy vaccine and experienced itching at the injection site.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; Injection site swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (expiry date 10-MAR-2027) for prophylaxis.   Concurrent medical conditions included sciatica.   On 30-APR-2025, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain) and injection site swelling (Verbatim: Injection site swelling). The outcome of the injection site pain and injection site swelling were not resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site swelling to be related to Shingrix.   Linked case(s) involving the same patient:  US2025081876   Additional Information: GSK Receipt Date: 30-JUN-2025 The patient self-reported this case. The patient received her first dose of Shingrix vaccine on 30th April 2025 and reported that she had pain and swollen of the injection site and she did not experience the sciatic pain with the 1st dose.  The patient had sciatic nerve issues and got treatment with a chiropractor and her condition was under control and had just left the chiropractor office when she went to get the 2nd dose of Shingrix. This case is linked with US2025081876, reported by same reporter.; Sender's Comments:  US-GSK-US2025081876:Same patient/Dose 2
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: adjuvant was given without being mixed with the active ingredient; adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 77D52, expiry date 16-SEP-2025) for prophylaxis.   On 13-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular). On 13-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 26-JUN-2025 Reporter state that only adjuvant was given without being mixed with the active ingredient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with case US2025061270, reported by the same reporter.; Sender's Comments:  US-GSK-US2025061270:Same reporter/Different patient
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: soreness). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUL-2025 Patient had some sourness after the 2nd shot and was wondering if they can take an iboprofen.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: Hypersensitivity rxns; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity rxns) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 vaccine for an unknown indication.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 vaccine (unknown route) 1 dosage form. On an unknown date, received second dose of COVID-19 vaccine (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity rxns). At the time of the report, HYPERSENSITIVITY (Hypersensitivity rxns) outcome was unknown.            Concomitant medication was not provided.  Patient took the vaccine 3.25 year ago. It was reported that the patient had experienced hypersensitivity reactions following her initial two doses and even more so after receiving a Moderna COVID-19 booster. It was told to the pharmacist upon arrival of patient severe reaction to mRNA vaccines was reported. Treatment information was not reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Cardiac ablation, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Progressive ventricular heart arrhythmia with pre-syncope, chest pain and hardship breathing; followed by pericarditis, enlarged right ventricle; hospitalization after 4 weeks as symptoms progressed; scheduled for heart surgery (catheterization ablation) in October 2021; post-surgery chest pain and vascular inflammation treated with high-dose ibuprofen; followed by undiagnosed autoimmune disorder first noticed as skin rash in January 2022, later diagnosed as granuloma annulare.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Inflammation, Magnetic resonance imaging heart, Pericarditis, Presyncope
Clinical narrative: Progressive ventricular heart arrhythmia with pre-syncope, chest pain and hardship breathing; followed by pericarditis, enlarged right ventricle; hospitalization after 4 weeks as symptoms progressed; scheduled for heart surgery (catheterization ablation) in October 2021; post-surgery chest pain and vascular inflammation treated with high-dose ibuprofen; followed by undiagnosed autoimmune disorder first noticed as skin rash in January 2022, later diagnosed as granuloma annulare.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Right ventricular enlargement, Ventricular arrhythmia
Clinical narrative: Progressive ventricular heart arrhythmia with pre-syncope, chest pain and hardship breathing; followed by pericarditis, enlarged right ventricle; hospitalization after 4 weeks as symptoms progressed; scheduled for heart surgery (catheterization ablation) in October 2021; post-surgery chest pain and vascular inflammation treated with high-dose ibuprofen; followed by undiagnosed autoimmune disorder first noticed as skin rash in January 2022, later diagnosed as granuloma annulare.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Blood glucose normal, Chills, Cold sweat, Loss of consciousness, Nausea
Clinical narrative: Patient passed out within seconds of the two shots. She woke up pale, clammy and nauseous. We waited at the office for another 30 minutes. She threw up on the way home and had chills, but no fever, when we arrived home.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pallor, Vomiting
Clinical narrative: Patient passed out within seconds of the two shots. She woke up pale, clammy and nauseous. We waited at the office for another 30 minutes. She threw up on the way home and had chills, but no fever, when we arrived home.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: The 1st dose of the Pfizer Covid 19 vax (April 2021) caused an outbreak of the Shingle virus (Sep 2021). The 2nd dose of the Pfizer vax (Feb 2022, due to employer mandate) caused 3 separate trips to the ER.  The symptoms were super high blood pressure (190/120), rapid heart rate, dizziness, breathing difficulty, numbness in my extremities.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased, Hypoaesthesia
Clinical narrative: The 1st dose of the Pfizer Covid 19 vax (April 2021) caused an outbreak of the Shingle virus (Sep 2021). The 2nd dose of the Pfizer vax (Feb 2022, due to employer mandate) caused 3 separate trips to the ER.  The symptoms were super high blood pressure (190/120), rapid heart rate, dizziness, breathing difficulty, numbness in my extremities.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given Prevnar 20 vaccine on 7/10/2025.  Patient had had already had the Prevnar 20 on 02/06/2024.  Notified the patient's provider.
Age: 81.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: No adverse event, Product prescribing error
Clinical narrative: Beyfortus ordered by provider and administered by medical assistant in error. Patient should have received Abrysvo instead. No adverse reactions noted.
Age: 58.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Large raised red welt approx 2x4 inches centered on injection site, additional 1 inch diameter welt above armpit on same side as injection
Age: 58.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Fatigue, Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Large raised red welt approx 2x4 inches centered on injection site, additional 1 inch diameter welt above armpit on same side as injection
Age: 55.0
Sex: M
Vaccine: PNC21
Symptoms: Fatigue, Lymphadenopathy, Rash, Rash papular, Tenderness
Clinical narrative: fatigue, swollen lymph node, raised tender rash under axilla on injection side
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Patient reported on 7/7/25  stating  she had a swollen gland under her left armpit, fever x2days, and a headache x3days.  Not aware of a treatment.  PCP was made aware and we marked her chart being allergic to the vaccine. We called her back  7/8/25 and the pt stated she was better.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Sleep disorder
Clinical narrative: Injection site reaction - Persistent pain and swelling at the site of recent pneumococcal vaccination - Onset of new redness and increased swelling yesterday - Pain is constant and severe, disrupting sleep - Tylenol provides no relief of symptoms - No similar reactions to previous vaccinations      Cellulitis Cellulitis at vaccination site, likely bacterial. Bactrim chosen due to penicillin allergy and stomach upset history. - Prescribe Bactrim DS (sulfamethoxazole and trimethoprim) for 14 days, minimum 7 days. - Advise Bactrim twice daily with food. - Prescribe Zofran (ondansetron) 4 mg as needed for nausea. - Recommend dietary prebiotics and probiotics. - Prescribe naproxen for pain and inflammation, advise with food. - Outline redness with skin pen for monitoring. - Schedule follow-up in 7 days. - Instruct to return if no improvement by Wednesday.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site cellulitis
Clinical narrative: Injection site reaction - Persistent pain and swelling at the site of recent pneumococcal vaccination - Onset of new redness and increased swelling yesterday - Pain is constant and severe, disrupting sleep - Tylenol provides no relief of symptoms - No similar reactions to previous vaccinations      Cellulitis Cellulitis at vaccination site, likely bacterial. Bactrim chosen due to penicillin allergy and stomach upset history. - Prescribe Bactrim DS (sulfamethoxazole and trimethoprim) for 14 days, minimum 7 days. - Advise Bactrim twice daily with food. - Prescribe Zofran (ondansetron) 4 mg as needed for nausea. - Recommend dietary prebiotics and probiotics. - Prescribe naproxen for pain and inflammation, advise with food. - Outline redness with skin pen for monitoring. - Schedule follow-up in 7 days. - Instruct to return if no improvement by Wednesday.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives all over the body on the same day of vaccine administered.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patients mother called, stated patient was given the incorrect vaccine. When the  mother turned in the MCIR to the school they noticed MenB was given to the  patient but Men Conjug should have been given. I told the mother i would look  into this and call her back. I verified doctor entered the order in the chart as  Men Conjug however, MenB lot# GH4067 was charted as given 7/1/2025. MenB was also  on the MCIR as given 7/1/2025. I verified the counts for MenB and Men Conjug were  correct (in fridge and MCIR). I notified doctor. Doctor asked me to call the  health department for clarification on adverse reactions and to call. I  spoke to someone at the Health Dept. She stated no harm will come from  giving the MenB vaccine early. This will not count toward her future MenB dose  when she is old enough to get it. She also stated patient could receive the  Men Conjug anytime. No waiting period. I did report all information back to  doctor and other. Mother was contacted and appt was made for 7/15/25 to  give Men Conjug to the patient.
Age: 69.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Swelling R arm x yesterday 7/9/25. Had got PCV 20 & Tdap 7/3/25 stated was fine then some swelling yesterday and more today. Mild red, mild itching no f/c/s no sob no pain no malaise no previous reaction
Age: 56.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: I made a mistake and administered the pediatric/adolescent Havrix instead of the adult Havrix. When I realized that I had made the mistake, I immediately notified my supervisor, (name withheld) R.N., and our Physician Assistant, (name withheld). They looked at Ask the Experts from the immunize.org for the remedy to the error and it was decided that we needed to call the patients (name withheld and his wife, name withheld DOB 10/XX/19XX, were both receiving travel vaccinations for a trip to (withheld). I will also be submitting a VAERS report for her because the same mistake was made with her Hep A vaccination) to have them return on the same day for a second dose of the pediatric/adolescent Havrix to complete the first dose of the Hep A series. They returned around 3:30pm and both patients were given a second dose of the pediatirc/adolescent Havrix. The intramuscular injections were given in the same arm. The same lot number was used. I gave them a reminder to make an appointment on or after 1/9/26 for the second Hep A in the series.
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: She met someone 3 days ago, who also experiences the same symptoms as her/nose bleeding; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "She met someone 3 days ago, who also experiences the same symptoms as her/nose bleeding".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: 3 of reporter's good friends died, after getting the so-called mRNA covid shots. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500081193 same product/event, different patient;US-PFIZER INC-PV202500081194 same product/event, different patient;; Reported Cause(s) of Death: Unknown cause of death
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: prolonged soreness at the injection site; in the arm that bruised; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series complete; manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset 2023, outcome "unknown", described as "in the arm that bruised"; VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "not recovered", described as "prolonged soreness at the injection site". The event "prolonged soreness at the injection site" required physician office visit. Additional information: The patient sought advice as their healthcare providers could not determine the cause. Patient got all the different Covid vaccine and the last vaccine has residual side effects and his family doctor can't figure out why. He is wondering why he is having that soreness still in the arm that bruised.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: As someone with a family member who has had hive reaction to Pfizer vaccines; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20250630000008 (Moderna).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), outcome "unknown", described as "As someone with a family member who has had hive reaction to Pfizer vaccines". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given too soon
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia universalis
Clinical narrative: Alopecia Universalis (global alopecia)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dry throat, Dysphagia, Injection site pain, Musculoskeletal pain
Clinical narrative: Day 1: sterile abscess at injection site. Day 2: deep muscle pain in deltoid, spreading to trapezius. Day 3: pain extended to scapula. Sudden onset of throat dryness + itchiness, simultaneous arm itchiness. Mild difficulty swallowing. Itchiness in throat and pain still ongoing on day 3 (today july 10th)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Throat irritation
Clinical narrative: Day 1: sterile abscess at injection site. Day 2: deep muscle pain in deltoid, spreading to trapezius. Day 3: pain extended to scapula. Sudden onset of throat dryness + itchiness, simultaneous arm itchiness. Mild difficulty swallowing. Itchiness in throat and pain still ongoing on day 3 (today july 10th)
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: The covid vaccine multidose vial was mixed on 7/8/2025. Was placed in med cabinet, not thrown away at the end of the day. A new Covid vaccine vial was mixed on 7/10/25 in the AM. In the afternoon, this patient was to get covid vaccine, MA accidentally pulled dose from the 7/8/2025 vial, not from the 7/10/2025 vial. Dose was given along with the other 6m vaccines. (pediarix, hiberix, rotateq and prevnar 20). No adverse reactions noted at time of administration
Age: 81.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PATIENT EXPERIENCED LOCAL SWELLING, REDNESS, AND ITCHINESS AT INJECTION SITE.  SWELLING, REDNESS, AND ITCHINESS HAS IMPROVED AND HELPED WITH ICING.
Age: 23.0
Sex: F
Vaccine: CHIK
Symptoms: Product preparation error
Clinical narrative: patient was given Ceftriaxone 500mg with 1 ml diluent instead of Bicillin L-A 1,200,000 units/2 ml
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented with severe pruritis, erythema, swelling to left arm where she received #2 dose of Shingrix on 7/9/2025. Lot #3J2S2 expires 3/27/2027. First dose received 4/28/2025 to the left arm without complications. Patient states the erythema does not hurt but it is very itchy. The entire left upper arm, from shoulder to elbow, is red with swelling (7 cm diameter) around the injection site. No fever or pain.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Cold sweat, Cyanosis, Headache, Heart rate increased
Clinical narrative: Headache, pale blue lips, rapid heartbeats, cold sweats, with in 20 minutes of administered injection
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient stated hives on both arms roughly 3 hours after vaccination - recommended go to hospital to have it looked at
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, Electroencephalogram abnormal, Joint noise, Muscle spasms, Myoclonic epilepsy
Clinical narrative: 1 day after I received the vaccine, I had popping in my spinal cord along with pain in my back and neck. I also began to develop muscle spasms that have gradually worsened ever since receiving the vaccine. These spasms would last up to 30 minutes at a time. Recently, on July 3rd, 2025, I had a significant round of muscle spasms that ended in a seizure. I was unresponsive and went to the hospital, where they diagnosed me with myoclonic epilepsy.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Neck pain, Seizure, Unresponsive to stimuli
Clinical narrative: 1 day after I received the vaccine, I had popping in my spinal cord along with pain in my back and neck. I also began to develop muscle spasms that have gradually worsened ever since receiving the vaccine. These spasms would last up to 30 minutes at a time. Recently, on July 3rd, 2025, I had a significant round of muscle spasms that ended in a seizure. I was unresponsive and went to the hospital, where they diagnosed me with myoclonic epilepsy.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Anxiety, Computerised tomogram normal, Confusional state, Dyskinesia, Electroencephalogram abnormal
Clinical narrative: 1 day after I received the vaccine, I had popping in my spinal cord along with pain in my back and neck. I also began to develop muscle spasms that have gradually worsened ever since receiving the vaccine. These spasms would last up to 30 minutes at a time. Recently, on July 3rd, 2025, I had a significant round of muscle spasms that ended in a seizure. I was unresponsive and went to the hospital, where they diagnosed me with myoclonic epilepsy.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Gaze palsy, Loss of consciousness, Magnetic resonance imaging head normal, Muscle contractions involuntary
Clinical narrative: 1 day after I received the vaccine, I had popping in my spinal cord along with pain in my back and neck. I also began to develop muscle spasms that have gradually worsened ever since receiving the vaccine. These spasms would last up to 30 minutes at a time. Recently, on July 3rd, 2025, I had a significant round of muscle spasms that ended in a seizure. I was unresponsive and went to the hospital, where they diagnosed me with myoclonic epilepsy.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Muscle rigidity, Muscle tightness, Myalgia, Nervousness, Poor quality sleep
Clinical narrative: 1 day after I received the vaccine, I had popping in my spinal cord along with pain in my back and neck. I also began to develop muscle spasms that have gradually worsened ever since receiving the vaccine. These spasms would last up to 30 minutes at a time. Recently, on July 3rd, 2025, I had a significant round of muscle spasms that ended in a seizure. I was unresponsive and went to the hospital, where they diagnosed me with myoclonic epilepsy.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Seizure, Tremor
Clinical narrative: 1 day after I received the vaccine, I had popping in my spinal cord along with pain in my back and neck. I also began to develop muscle spasms that have gradually worsened ever since receiving the vaccine. These spasms would last up to 30 minutes at a time. Recently, on July 3rd, 2025, I had a significant round of muscle spasms that ended in a seizure. I was unresponsive and went to the hospital, where they diagnosed me with myoclonic epilepsy.
Age: 87.0
Sex: M
Vaccine: PNC21
Symptoms: Chest discomfort, Dyspnoea, Pneumonia, Walking aid user
Clinical narrative: PATIENT WENT TO HOSPITAL 2 DAYS LATER, HEAVY IN THE CHEST AND PROBLEMS BREATHING. DEVELOPED UPPER LOBE PNEUMONIA AND WAS PLACED ON ANTIBIOTICS.  EVER SINCE, HAS NEEDED CONTINOUS OXYGEN SUPPLEMENTATION, GOING OUT AND BUYING A PORTABLE MACHINE AND NEEDS TO USE A WALKER.
Age: 1.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Developmental delay, Dyskinesia, Electroencephalogram abnormal, Gliosis, Magnetic resonance imaging head abnormal
Clinical narrative: My son was a healthy, normally developing child with no prior medical issues, seizures, or neurological concerns. He was born full-term without complications, and reached all developmental milestones early ? standing at 7 months, walking at 10 months, and talking before his first birthday. He had never experienced any high fever, infection, or unusual symptoms.  On 02/11/2025, he received routine childhood vaccinations, including DTaP, Polio, Hep B, HIB, administered by intramuscular injection into his left/right thigh.  Within a few hours of receiving the vaccine, while sleeping, he let out a loud, sudden scream and was found by his mother in an active seizure ? involving body shaking and jerking. He had no fever at the time. This was his first-ever seizure.  Following this event, he began experiencing recurrent myoclonic seizures, primarily during sleep but occasionally while awake. These included sudden jerks, dropping objects, and body twitches. His pediatrician referred him to a pediatric neurologist.  An EEG confirmed abnormal electrical activity consistent with myoclonic epilepsy. An MRI of the brain revealed multifocal white matter abnormalities with gliosis, indicating brain scarring from a prior injury.  He was prescribed Levetiracetam (Keppra) for seizure control, which he continues to take daily.  Despite treatment, seizures have persisted. There is growing concern from the family that this was a vaccine-induced neurological injury, as the onset of symptoms was immediate and no other cause (genetic, metabolic, infectious, or traumatic) has been identified. His development, although initially advanced, has shown some slowing since the incident.
Age: 1.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Muscle twitching, Myoclonic epilepsy, Screaming, Seizure, Tremor
Clinical narrative: My son was a healthy, normally developing child with no prior medical issues, seizures, or neurological concerns. He was born full-term without complications, and reached all developmental milestones early ? standing at 7 months, walking at 10 months, and talking before his first birthday. He had never experienced any high fever, infection, or unusual symptoms.  On 02/11/2025, he received routine childhood vaccinations, including DTaP, Polio, Hep B, HIB, administered by intramuscular injection into his left/right thigh.  Within a few hours of receiving the vaccine, while sleeping, he let out a loud, sudden scream and was found by his mother in an active seizure ? involving body shaking and jerking. He had no fever at the time. This was his first-ever seizure.  Following this event, he began experiencing recurrent myoclonic seizures, primarily during sleep but occasionally while awake. These included sudden jerks, dropping objects, and body twitches. His pediatrician referred him to a pediatric neurologist.  An EEG confirmed abnormal electrical activity consistent with myoclonic epilepsy. An MRI of the brain revealed multifocal white matter abnormalities with gliosis, indicating brain scarring from a prior injury.  He was prescribed Levetiracetam (Keppra) for seizure control, which he continues to take daily.  Despite treatment, seizures have persisted. There is growing concern from the family that this was a vaccine-induced neurological injury, as the onset of symptoms was immediate and no other cause (genetic, metabolic, infectious, or traumatic) has been identified. His development, although initially advanced, has shown some slowing since the incident.
Age: 1.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: White matter lesion
Clinical narrative: My son was a healthy, normally developing child with no prior medical issues, seizures, or neurological concerns. He was born full-term without complications, and reached all developmental milestones early ? standing at 7 months, walking at 10 months, and talking before his first birthday. He had never experienced any high fever, infection, or unusual symptoms.  On 02/11/2025, he received routine childhood vaccinations, including DTaP, Polio, Hep B, HIB, administered by intramuscular injection into his left/right thigh.  Within a few hours of receiving the vaccine, while sleeping, he let out a loud, sudden scream and was found by his mother in an active seizure ? involving body shaking and jerking. He had no fever at the time. This was his first-ever seizure.  Following this event, he began experiencing recurrent myoclonic seizures, primarily during sleep but occasionally while awake. These included sudden jerks, dropping objects, and body twitches. His pediatrician referred him to a pediatric neurologist.  An EEG confirmed abnormal electrical activity consistent with myoclonic epilepsy. An MRI of the brain revealed multifocal white matter abnormalities with gliosis, indicating brain scarring from a prior injury.  He was prescribed Levetiracetam (Keppra) for seizure control, which he continues to take daily.  Despite treatment, seizures have persisted. There is growing concern from the family that this was a vaccine-induced neurological injury, as the onset of symptoms was immediate and no other cause (genetic, metabolic, infectious, or traumatic) has been identified. His development, although initially advanced, has shown some slowing since the incident.
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Allergy to vaccine
Clinical narrative: allergy to vaccine; This spontaneous report was received from a Physician and refers to a 58-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (25MCG/0.5) (strength, dose, dose number, route, lot #, expiration date and anatomical location were not reported) for Prophylaxis. On an unknown date, the patient experienced allergy to those vaccines. At the reporting time, the outcome of allergy to vaccine was unknown.   The reporter considered the event of allergy to vaccine to be related to both vaccines. This is one of two reports received from the same patient (2301380).
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted; This spontaneous report was received from a Nurse via company representative and refers to an Adolescent male patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date (recently), the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced fainted after receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) at the office.   At the reporting time, the outcome of fainted was unknown.   The causal relationship between the event of fainted and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown (They were not certain that it was associated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) and the patient had not eaten that morning).   Upon internal review, the event(s) of fainted was determined to be medically significant.