chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature source(s).  An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "solid organ transplant recipients" (unspecified if ongoing), notes: with a functional graft. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "SARS-CoV-2 infection". Additional information: the patient age was over 18 years. SOT recipients with a functional graft, recipients beyond one month of transplant. At least one-month post second dose of BNT162b2 vaccine. The patient received the 3rd dose of BNT162b2 then got SARS-COV-2 infection before 6th month blood draw after dose 3.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025503 Same article/event and different patient;
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature source(s).  An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "solid organ transplant recipients" (unspecified if ongoing), notes: with a functional graft. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "SARS-CoV-2 infection". Additional information: the patient age was over 18 years. SOT recipients with a functional graft, recipients beyond one month of transplant. At least one-month post second dose of BNT162b2 vaccine. The patient received the 3rd dose of BNT162b2 then got SARS-COV-2 infection before 6th month blood draw after dose 3.; Sender's Comments: A lack of efficacy with BNT162B2 cannot be completely excluded.  The patient's underlying medical condition being solid organ transplant recipient contribute to suboptimal response after vaccination.,Linked Report(s) : US-PFIZER INC-PV202500025503 Same article/event and different patient;
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash has flared back up on his arms in the last; itchy rash on the top of his left arm/on the top of his right arm from his wrist to elbow; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number 24M7E, expiry date 06-APR-2026) for prophylaxis.   The patient's past medical history included cardiac arrest. Concurrent medical conditions included mitral valve incompetence (10 years ago) and heart disorder. Concomitant products included propranolol, losartan, furosemide and warfarin.   On 21-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm). In SEP-2024, 2 weeks after receiving Shingrix, the patient experienced itchy rash (Verbatim: itchy rash on the top of his left arm/on the top of his right arm from his wrist to elbow). In FEB-2025, the patient experienced condition aggravated (Verbatim: Rash has flared back up on his arms in the last). The outcome of the itchy rash and condition aggravated were not resolved.   It was unknown if the reporter considered the itchy rash and condition aggravated to be related to Shingrix.     It was unknown if the company considered the itchy rash and condition aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-FEB-2025 and 03-MAR-2025 The patient self-reported this case. The patient received the first dose of Shingrix for shingles prevention and a couple of weeks after receiving the first dose he had an itchy rash on the top of his right arm from his wrist to his elbow and that around the end of November 2024 to early December 2024 (no specific date  provided) he also had this itchy rash on the top of his left arm from his wrist to his elbow and on the top of his chest from below his neck to about the end of of his chest cage. By the top of his arms, the patient meant the top side of his forearms.  The patient still had all of these same itchy rash areas today (on the reporting day)  The patient reported that the rash seemed to start to dissipate, but had flared back up on his arms in the last week or so (no specific dates  provided) and the presentation on his left arm at first was not as bad as the presentation on his right arm at first.  The patient had seen 3 healthcare providers about this itchy rash. One provided him a topical (Unknown Product Information) that he used for a month and it helped a little bit.  The patient has tried over the counter salves and lotions (Unknown Products Information) and right now was using topical Aloe (Unknown Product Information).  The patient reported that he blew his mitral valve 10 years ago and flat lined 24 hours later (Pre Existing Shingrix).  The patient did not had any paper work to provide, but said he received the vaccine from his Pharmacist.  The patient had been on all of his concurrent medications for 10 years, all pre-existing receiving Shingrix, but took them all the day the vaccine was received.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got 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: got 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 to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she took the Shingles shot and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient given pediatric Hep B vaccine instead of adult Hep B vaccine. Patient monitored post injection, no adverse reactions noted.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination given past 10 week refrigerated expiratory date.
Age: 41.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse events noted, patient was monitored post injection. Patient was given pediatric Hep B vaccine instead of adult Hep B vaccine.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination given past 10 week refrigerated expiratory date.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: BioNTech use for COVID-19 under Emergency Use Authorization (EUA): Vaccination given past 10 week refrigerated expiratory date.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure, Syncope
Clinical narrative: To Whom It May Concern, I am writing to express my grave concern regarding a serious adverse reaction my daughter experienced following the administration of the Gardasil HPV vaccine. On 2/26/2025, she received her second dose to the vaccine, and shortly afterward, she suffered an episode of syncope followed by two seizures. This event has left us deeply worried about her health and well-being, and we are seeking your assistance in understanding the potential connection between the vaccine and this serious reaction. My daughter was in good health prior to receiving the vaccine, and the timing of the syncope and seizure immediately following vaccination has led us to wonder whether there may be underlying factors that could predispose her to such a response. Given the seriousness of this incident, I am requesting more information on whether there are any specific guidelines or recommendations regarding pre-vaccination testing, such as blood work or screenings, to identify individuals who might be at increased risk for adverse reactions. In particular, tests for underlying conditions that could contribute to episodes of syncope, seizures, or other reactions could be valuable in ensuring the safety of all vaccine recipients. Additionally, we would appreciate any information on known adverse effects of the Gardasil vaccine that might be related to syncope or seizures, and whether these side effects are typically reported in the context of your post-marketing surveillance. We also seek guidance on the next steps in addressing my daughter's health and ensuring proper medical care moving forward. We are very concerned about the potential risks associated with this vaccine, and we strongly believe that proactive testing could be a critical step in preventing adverse reactions in the future. Thank you for your attention to this matter. We look forward to hearing from you and receiving the guidance and support we need to ensure my daughter's safety and well-being. Sincerely
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Computerised tomogram thorax abnormal, Extra dose administered, Pulmonary embolism
Clinical narrative: Patient admitted to the hospital on 2/14/2025 with pulmonary Embolus. on 12/4/2024 her pharmacy accidentally gave her 2 Pfizer Comirnaty immunizations. Other risk factors include OCP, obesity, recent hysterectomy.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Neonatal disorder
Clinical narrative: I was pregnant while receiving the Covid vaccine. Child was born 9/XX/XX, with a large swollen head and a normal trunk/legs that looked tiny compared to her head. We had concerns about child's growth and development. By 16 months of age, we brought child to the hospital because of polyps and extreme discharge coming out of her ear, which resulted in a CT scan determining large lesions that had been growing for many months. She was diagnosed with a slow growing rare cancer called Langerhans Cell Histiocytosis, which had taken up her whole right mastoid (and coming out of her ear), her left mastoid, her spleen, and liver shadows. This disease was in her body for a long period of time and continued progressing. Now that research is coming out about Covid vaccines and rare complications such as LCH, I am concerned about my child's future because of the 2 vaccines I received while pregnant. The vaccines were pushed on me to be ?safe and effective? yet it was such a new vaccine that more research should have been done to safely say the warnings and concerns. I have been saying since day 1 of her diagnosis that it was the vaccine when I was pregnant (and I am pro-vaccine!).
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Client was inadvertently given the Gardasil vaccine, dose #3,  too soon. It was not due until June.  There were no adverse effects. Client was made aware and she is scheduled to come back in June for the 3rd dose.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: redness on right arm, slight swelling, soreness.   NO evidence of fever or other systemic related symptoms
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Syringe issue
Clinical narrative: RN was administering the vaccine to patient. She injected it into left thigh. As she pushed plunger down to administer vaccine, the vaccine sprayed out of the syringe. After looking close after the event, there appeared to be a crack in syringe. Our VFC program advised us to report this to VAERS. Vaccine manufacturer is also aware of this, and the syringe has been sent in to Sanofi.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site raised, firm, and warm to touch.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Shoulder Injury Related to Vaccine Administration (SYMPTOMS: inflammation, redness and painful site of injection)
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given Kinrix (combo vaccine which includes Dtap and Polio) on 03/05/2025. However when Immpact was updated after vaccine was given it listed the Kinrix as NOT VALID. I called Immpact on 03/05/2025 but was not able to speak with anyone; I had to leave a voicemail. When I spoke to Immpact on 03/06/2025 I was told that the Kinrix was NOT VALID because it's only licensed to be the 5th Dtap dose and the 4th or 5th Polio dose for a patient. Immpact told me that despite that the doses the patient received yesterday ARE VALID but Immpact cannot change how it's listed in the patient's immunization record in Immpact.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Confusional state, Fatigue, Headache, Hip arthroplasty
Clinical narrative: First 24 hours severe body aches, HA, fever, some of the typical reactions I had heard being a physician myself. Chest pain and palpitations started within 48 hours. Lasted months. Work up normal. Months later began having sores on toes c/w vasculitis. Chronic fatigue that seems to greatly worsen anytime sick. Extreme weight loss and muscle wasting. Confusion to the point I can not work as a physician at times. Tends to correlate with illness and extreme fatigue. Unable to work 12 hours shifts I did prior to vaccine. After 4 years finally have been forced to work a much reduced schedule. All symptoms started prior to actually having covid itself which I have had only once and basically had allergy symptoms for a day. Avascular necrosis found in hip in 2022. Hip replaced that year.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test, Muscle atrophy, Osteonecrosis, Pain
Clinical narrative: First 24 hours severe body aches, HA, fever, some of the typical reactions I had heard being a physician myself. Chest pain and palpitations started within 48 hours. Lasted months. Work up normal. Months later began having sores on toes c/w vasculitis. Chronic fatigue that seems to greatly worsen anytime sick. Extreme weight loss and muscle wasting. Confusion to the point I can not work as a physician at times. Tends to correlate with illness and extreme fatigue. Unable to work 12 hours shifts I did prior to vaccine. After 4 years finally have been forced to work a much reduced schedule. All symptoms started prior to actually having covid itself which I have had only once and basically had allergy symptoms for a day. Avascular necrosis found in hip in 2022. Hip replaced that year.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, Rash, Weight decreased
Clinical narrative: First 24 hours severe body aches, HA, fever, some of the typical reactions I had heard being a physician myself. Chest pain and palpitations started within 48 hours. Lasted months. Work up normal. Months later began having sores on toes c/w vasculitis. Chronic fatigue that seems to greatly worsen anytime sick. Extreme weight loss and muscle wasting. Confusion to the point I can not work as a physician at times. Tends to correlate with illness and extreme fatigue. Unable to work 12 hours shifts I did prior to vaccine. After 4 years finally have been forced to work a much reduced schedule. All symptoms started prior to actually having covid itself which I have had only once and basically had allergy symptoms for a day. Avascular necrosis found in hip in 2022. Hip replaced that year.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3, MENB, MNQ
Symptoms: Dizziness, Dyspnoea, Headache, Pain
Clinical narrative: 2230 patient complained to her mom of headache, body aches and shortness of breath. She used her inhaler and took some Tylenol, then while heading back to her room she became lightheaded.
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired 6m-4y covid administered on 1/22/25, it was discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, but parent stated they would call back to schedule. Per parent, patient did not experience any adverse reactions/ negative symptoms post vaccine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Pyrexia, Respiratory viral panel, Vomiting
Clinical narrative: Patient began with fever, headache, vomiting & fatigue the next day after vaccine- 3/4/25. He was seen in office on 3/5/25. A viral respiratory panel was done to rule out viral illness, this was negative.
Age: 3.0
Sex: F
Vaccine: COVID19, FLU3, HEPA
Symptoms: Expired product administered, Malaise, Ocular hyperaemia, Pyrexia
Clinical narrative: Expired 6m-4y covid administered on 1/24/25, it was discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, but parent stated they would call back to schedule. Per parent, patient was "sick for 3 days" with a fever in the evenings and red eyes.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Rash
Clinical narrative: Covid arm- with rash 11 days later after first vaccine. Then a mass developed and now has moved "up" my arm to shoulder blade.
Age: 2.0
Sex: F
Vaccine: COVID19, FLU3, HEPA
Symptoms: Expired product administered
Clinical narrative: Expired 6m-4y covid administered 1/24/25. Event discovered on 2/11/25. Attempted to call parent x2 and database message sent to have parent call clinic back. No call/ message back. Patient will need to be revaccinated.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC20
Symptoms: Product preparation issue
Clinical narrative: It was discovered  on 2/21/25 that PT only received the sterile solution portion of the Hib vaccine on 2/20/25 around 10AM This was verified via immunization sheet as it has only the sterile solution sticker. RN noticed the count was off for the Hib vaccine (dilutent vs powder) and discussed with MA, and she checked the completed immunizations vaccine folder and found this patients immunizations sheet and confirmed with myself, and someone else the following work day. The event was discussed with Quality, the ordering Provider and the manufacturer and it was recommended that patient be vaccinated with a Hiberix properly. The event was discussed with mom, her concern was to make sure that patient was not vaccinated twice. We assured mom that our documented immunization sheets proved that patient did not recieve the activated vaccination, just the sterile solution.  Mom made a nurse visit for 2/26/25 and patient recieved the activated immunization.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired 6m-4y covid administered on 1/24/25. Event discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, patient scheduled for revaccination. Per parent, no adverse reactions/ negative symptoms post vaccination.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Apnoea, Blood test, Hypopnoea, Hypotonia, Hypotonic-hyporesponsive episode
Clinical narrative: 11/07/2022 - Patient had a fever after getting his immunizations. We gave him 1 dose of infant's tylenol before bed.  11/08/2022 - Hypotonic-Hyporesonsive Syndrome... (decreased muscle tone / extreme limpness, unresponsive to stimuli, [pallor] change in skin tone ). In addition, several moments (30-60 seconds) of not breathing, followed by about 5 minutes of very shallow breathing. Patient was rushed to the EMERGENCY ROOM via ambulance. Many tests were done at the hospital (blood work, imaging, etc.), but no diagnoses were made and, as a result, no treatments were given to patient. We were sent home with nothing, but a HUGE bill from the hospital...
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Imaging procedure, Pallor, Pyrexia, Unresponsive to stimuli
Clinical narrative: 11/07/2022 - Patient had a fever after getting his immunizations. We gave him 1 dose of infant's tylenol before bed.  11/08/2022 - Hypotonic-Hyporesonsive Syndrome... (decreased muscle tone / extreme limpness, unresponsive to stimuli, [pallor] change in skin tone ). In addition, several moments (30-60 seconds) of not breathing, followed by about 5 minutes of very shallow breathing. Patient was rushed to the EMERGENCY ROOM via ambulance. Many tests were done at the hospital (blood work, imaging, etc.), but no diagnoses were made and, as a result, no treatments were given to patient. We were sent home with nothing, but a HUGE bill from the hospital...
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired 6m-4y covid administered on 1/27/25. Event discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, but parent would like to speak with PCP at next visit before revaccination. Per parent, no adverse reactions/ negative symptoms post vaccination.
Age: 3.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired 6m-4y covid administered on 1/28/25. Event discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, patient scheduled for revaccination. Per parent, no adverse reactions/ negative symptoms post vaccination.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired 6m-4y covid administered on 1/29/25. Event discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, patient scheduled for revaccination. Per parent, no adverse reactions/ negative symptoms post vaccination.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Headache, body pain, stiffness, body aches
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the BUD which was 2/5/2025.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered after the BUD of 2/3/2025
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received DTAP, IPV and HIB before actual due date. No adverse reactions.
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Heart rate increased, Pain
Clinical narrative: Patient states experienced body aches and chills as well as elevated heart rate after receiving the vaccine. Patient states the elevated heart rate lasted around 24 hours then resolved on its own.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Paraesthesia
Clinical narrative: Left shoulder pain, left arm numbness, pins and needles feeling from shoulder to finger tips, can't lift left shoulder
Age: 10.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was due for Tdap and received in Dtap at approximately 0845 on 3/6/25. No adverse signs or symptoms noted. Patient present with family member. Family member made aware of event with no further questions or concerns.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received flu vaccine on 3/1/25 but pt had already received a dose for this season on 9/30/24. Spoke with patient and advised no harm to patient.
Age: 45.0
Sex: F
Vaccine: PNC20
Symptoms: Skin discolouration
Clinical narrative: Left leg skin discoloration 1 day later.  No other areas of the body affected.  Claritin daily & derm f/u if not resolved recommended.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered.  No adverse reactions noted.  Parent notified
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling and warmth to area.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, Laboratory test, Polymyalgia rheumatica, Rash, Skin cancer
Clinical narrative: Started with a rash and then diagnosed with PMR and many other blood disorders, skin cancer tumors.
Age: 30.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired Meningococcal Vaccine, pt was monitored no adverse events happened. Patient was notified and educated on the incident.
Age: 58.0
Sex: F
Vaccine: HEPAB, MMR, PNC21
Symptoms: Diarrhoea, Dizziness, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient received vaccines on a Friday afternoon.  By Saturday evening she claimed to have nausea and vomiting, dizziness, fever, loose stools and pain and redness at the injection site.  At this time a rash began to form on her Right arm.  She presented to the pharmacy today (7 days later) still suffering with an extensive rash and swelling from the shoulder to the elbow.  All other symptoms subsided.  Despite using ice and Benadryl, the rash has not subsided.
Age: 58.0
Sex: F
Vaccine: HEPAB, MMR, PNC21
Symptoms: Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient received vaccines on a Friday afternoon.  By Saturday evening she claimed to have nausea and vomiting, dizziness, fever, loose stools and pain and redness at the injection site.  At this time a rash began to form on her Right arm.  She presented to the pharmacy today (7 days later) still suffering with an extensive rash and swelling from the shoulder to the elbow.  All other symptoms subsided.  Despite using ice and Benadryl, the rash has not subsided.
Age: 0.17
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site nodule
Clinical narrative: "Subcutaneous nodule" has persisted on L thigh since vaccination.  Per mother of patient, initially had bruise in the location, then a small bump appeared and has stayed the same size.
Age: 26.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt. was seen in OB/GYN office today for wellness exam, her titers for Varicella and Rubella showed low, so Dr.  recommend pt get MMR and VARICELLA prior to getting pregnant. I  Lvn accidently gave pt.  a double dose of Varicella.  While pulling vaccine out of freezer I just saw MMR and pulled a Varicella vial. After administering the vaccines while going to log vaccines noticed I gave MMRV and Varicella.  Had pt. stay in office for 20 minutes to see if she had any adverse reaction and she had no redness or swelling to inj. site. The made my Dr. and Supervisor aware of incident and called CDC and gave me VARES.HSS.GOV website to fill out medication error.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old patient received a rotavirus vaccine when the vaccine history showed no previous doses. Therefore this dose was not needed at this age. No harm to Patient.  Provider attempted to notify family but is unable to reach at this time.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Contracted mild case of varicella
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site reaction
Clinical narrative: Injection site reaction: erythema, inflammation, itching, edema.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: **Patient was inadvertently given a second dose of RSV vaccine. She had received one dose previously on 1-31-25.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Atrial fibrillation, Electrocardiogram ambulatory abnormal, Myalgia, Palpitations, Tachycardia
Clinical narrative: Several days of muscle pain after the vaccine and leading up to the ?event? on March 1st.  At approximately 11:00 on 3/1/2025, I developed significant tachycardia with exercise.  I felt palpitations.  Apple Watch determined it to be Atrial Fibrillation.  Despite ceasing exercise, and increasing hydration, it took 6 hours to revert to normal sinus rhythm.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cough, Dizziness, Pruritus, Urticaria
Clinical narrative: Hives all over his face, especially around the eyes, arms, torso. 911 was called at 11:34 am, EMS arrived at 11:40 am. EMS transported the student to ER. IV was inserted and Benadryl 0.5ml was administered. V/S Pulse 118, BP 133/76, O2 sat 94-95. Student was dizzy and felt itchy with slight cough noted. Denied shortnes of breath
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: This patient was given 2 shots (same lot and exp.)
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling of right arm with redness
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: 12:08 PM   Pt came in with mom and dad for a 2 year check up. Pt immunization record reviewed and pt needed #2 of Hep A, DTap, and was behind on Prevnar 20. RN offered for Prevnar 20 to be administered and parents agreed. Pt vaccines prepared and administered safely in the allocated immunization room with both parents present along with a younger sibling. Pt identification verified correctly from both parents. Parents stated before child receiving vaccines pt did not have any adverse reactions to any immunizations previously given. Immunization vaccines teaching provided for parents to wait in clinic 15-20 minutes to see if pt develops adverse reactions. Post vaccine administration, RN was charting vaccine details and RN saw the pt received pediarix versus infarix giving the pt an extra dose of polio and hep b. After the notice of mistake, RN searched for pt in the clinic and pt was already gone. Multiple phone calls were made to (three times) and two times to with voice messages for parents to call  Clinic back at . RN still awaiting for a return phone call. Patient Safety Reporting questionnaire filled out and VAERS completed.                                                                                                                                                                                                       1558: Pt's mother called the clinic back and was informed of what happened. Questions answered and pt's mom was appreciative of letting her know what happened. Pt's mom states the pt did not have any adverse reactions.
Age: 73.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Tuberculin solution mixed with Meningococcal Oligosaccharide (Menveo) and administered IM.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pain
Clinical narrative: Had covid and influenza vaccine on same day. Doesn't remember which are received which vaccine. Started having pain left arm with the injection. Radiates from injection site to lateral epicondyle, and anterior forearm. Has associated erythema, warmth, and soft issue mass. This was her first f/u since the vaccine admin.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Ultrasound scan normal
Clinical narrative: Had covid and influenza vaccine on same day. Doesn't remember which are received which vaccine. Started having pain left arm with the injection. Radiates from injection site to lateral epicondyle, and anterior forearm. Has associated erythema, warmth, and soft issue mass. This was her first f/u since the vaccine admin.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate increased
Clinical narrative: patient experienced fast heart rate over time and body did not feel right
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Decreased appetite, Dyspnoea, Headache
Clinical narrative: Immediatley after recieving flu shot, had pain upon injection site and skin felt hot. Driving back from appointment still felt hot and had pain upon injection site. When I got back to my room, I saw that I had hives on my abdomen. Later that night I had pain upon injection site, joint pain, and loss of appetite. Since then have experienced a cough, shortness of breath, constant headaches, joint pain, and developed a high fever and neck pain.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site warmth, Neck pain, Pyrexia
Clinical narrative: Immediatley after recieving flu shot, had pain upon injection site and skin felt hot. Driving back from appointment still felt hot and had pain upon injection site. When I got back to my room, I saw that I had hives on my abdomen. Later that night I had pain upon injection site, joint pain, and loss of appetite. Since then have experienced a cough, shortness of breath, constant headaches, joint pain, and developed a high fever and neck pain.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Immediatley after recieving flu shot, had pain upon injection site and skin felt hot. Driving back from appointment still felt hot and had pain upon injection site. When I got back to my room, I saw that I had hives on my abdomen. Later that night I had pain upon injection site, joint pain, and loss of appetite. Since then have experienced a cough, shortness of breath, constant headaches, joint pain, and developed a high fever and neck pain.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: This vaccine was given once in December of 2023, and again in March of 2025.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Alopecia, Angioedema, Anti-thyroid antibody increased, Antinuclear antibody increased, Autoimmune disorder
Clinical narrative: Patient received the 3rd dose of Gardasil on 11/16/2016 along with her flu shot for that year. She then returned to school and we had to pick her up because her lips started swelling (we have pictures from that day because of the severity of the swelling). We called the nurse line and asked about it and she told us that "if she was breathing ok then it should go away and she will be fine". Fast forward many years later and she is dealing with chronic autoimmune disorders. She lost almost all of her hair and was diagnosed with severe alopecia and now has to be on a lifelong Jak inhibitor for hair growth. We have spent countless hours at specialists' doctors' offices (rheumatologist, endocrinologist, dermatologist) and many hours battling health insurance companies for coverage. We've had to come out of pocket for more comprehensive blood panels to try and find answers. Since the shot in 2016, Patient has dealt with many symptoms such as POTS type symptoms, dysautonomia, severe alopecia (which led to mental trauma from losing almost all of her hair), sun sensitivity, and always high autoimmune panels. Patient will now have to be on a very expensive JAK Inhibitor for life to keep her hair. Patient had no preexisting conditions, and we believe that this 3rd round of Gardasil was the trigger for these autoimmune disorders and feel that this should be tracked for vaccine-related injuries.  Signs and Symptoms that developed over the years after the 3rd dose of Gardasil: Severe swelling of lips, same day as Gardasil shot. Sun sensitivity Dizzy spells Racing heart rate Lupus type flareups with butterfly rashes  Severe alopecia, which required wigs and now lifelong, very expensive medicine to grow hair Depression from hair loss Elevated ANA levels Gluten sensitivity Fatigued Brain Fog POTS symptoms Irregular periods Elevated thyroid antibodies indicating Hashimoto's
Age: 12.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Autonomic nervous system imbalance, Brain fog, Butterfly rash, Dizziness, Fatigue
Clinical narrative: Patient received the 3rd dose of Gardasil on 11/16/2016 along with her flu shot for that year. She then returned to school and we had to pick her up because her lips started swelling (we have pictures from that day because of the severity of the swelling). We called the nurse line and asked about it and she told us that "if she was breathing ok then it should go away and she will be fine". Fast forward many years later and she is dealing with chronic autoimmune disorders. She lost almost all of her hair and was diagnosed with severe alopecia and now has to be on a lifelong Jak inhibitor for hair growth. We have spent countless hours at specialists' doctors' offices (rheumatologist, endocrinologist, dermatologist) and many hours battling health insurance companies for coverage. We've had to come out of pocket for more comprehensive blood panels to try and find answers. Since the shot in 2016, Patient has dealt with many symptoms such as POTS type symptoms, dysautonomia, severe alopecia (which led to mental trauma from losing almost all of her hair), sun sensitivity, and always high autoimmune panels. Patient will now have to be on a very expensive JAK Inhibitor for life to keep her hair. Patient had no preexisting conditions, and we believe that this 3rd round of Gardasil was the trigger for these autoimmune disorders and feel that this should be tracked for vaccine-related injuries.  Signs and Symptoms that developed over the years after the 3rd dose of Gardasil: Severe swelling of lips, same day as Gardasil shot. Sun sensitivity Dizzy spells Racing heart rate Lupus type flareups with butterfly rashes  Severe alopecia, which required wigs and now lifelong, very expensive medicine to grow hair Depression from hair loss Elevated ANA levels Gluten sensitivity Fatigued Brain Fog POTS symptoms Irregular periods Elevated thyroid antibodies indicating Hashimoto's
Age: 12.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Gluten sensitivity, Menstruation irregular, Neurological symptom, Palpitations, Photosensitivity reaction
Clinical narrative: Patient received the 3rd dose of Gardasil on 11/16/2016 along with her flu shot for that year. She then returned to school and we had to pick her up because her lips started swelling (we have pictures from that day because of the severity of the swelling). We called the nurse line and asked about it and she told us that "if she was breathing ok then it should go away and she will be fine". Fast forward many years later and she is dealing with chronic autoimmune disorders. She lost almost all of her hair and was diagnosed with severe alopecia and now has to be on a lifelong Jak inhibitor for hair growth. We have spent countless hours at specialists' doctors' offices (rheumatologist, endocrinologist, dermatologist) and many hours battling health insurance companies for coverage. We've had to come out of pocket for more comprehensive blood panels to try and find answers. Since the shot in 2016, Patient has dealt with many symptoms such as POTS type symptoms, dysautonomia, severe alopecia (which led to mental trauma from losing almost all of her hair), sun sensitivity, and always high autoimmune panels. Patient will now have to be on a very expensive JAK Inhibitor for life to keep her hair. Patient had no preexisting conditions, and we believe that this 3rd round of Gardasil was the trigger for these autoimmune disorders and feel that this should be tracked for vaccine-related injuries.  Signs and Symptoms that developed over the years after the 3rd dose of Gardasil: Severe swelling of lips, same day as Gardasil shot. Sun sensitivity Dizzy spells Racing heart rate Lupus type flareups with butterfly rashes  Severe alopecia, which required wigs and now lifelong, very expensive medicine to grow hair Depression from hair loss Elevated ANA levels Gluten sensitivity Fatigued Brain Fog POTS symptoms Irregular periods Elevated thyroid antibodies indicating Hashimoto's
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient's caregiver brought this patient in for vaccines and after administration stated " her boss texted her and he already received a flu vaccine in November."
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: patient  received immunization and called two days later to report to us that she had developed cellulitis at the injection site. Patient received amoxicillin for treatment.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Pain in extremity
Clinical narrative: Pt came to pharmacy on 03/05/2025 after receiving vaccine on 02/28/2025 stating his arm was sore and had a bruise. He showed me a bruise on his right arm which appeared to start 2-3 inches from the middle of his deltoid, where the vaccine was administered. The bruise also appeared to have "leaked" down the from of his arm.  I did notice a number of similar appearing bruises on his left arm which appeared to have been there longer.  He stated the bruise seemed to be improving, so I recommended he continue to monitor.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient's caregiver brought this patient in for vaccines and after administration stated " her boss texted her and he already received a flu vaccine in November."
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: Child was given MMR vaccine. Left the clinic. Returned about 15 minutes later seizing and unresponsive. Oxygen given. IM Ativan given x3. Patient transported to nearest hospital by EMS.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscle atrophy, Pain
Clinical narrative: Patient reported feeling pain in injection site on 10/8/2024 a few days after receiving the vaccine on 10/4/2024.  Patient reported unable to use the left arm to reach across her body nor could she lift the left arm.  She took acetaminophen and ibuprofen on 10/31/24 for her arm pain and did some massage and physical therapy.  She also had lidocaine patch and prednisone 20mg once daily prescribed to her on 11/22/24 for her arm pain.  The doctor noticed she had lost muscle in the left arm at that time.  On 2/6/25, she had a physical exam with her doctor, and she still has some residual pain.  Today on 3/6/25 she called our pharmacy and reported the injury and that she feels better but some movements still hurt and the injection site still tender, but the pain is very mild now.  She stated that taking the prednisone 20mg once daily for 5 days in November really helped with her pain.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Blood test, Electromyogram, Hypoaesthesia, Lumbar puncture, Mobility decreased
Clinical narrative: late November I started to have numbness and tingling in my hands and feet, on the morning of December 4 I tried to stand up and collapsed to the floor.  I was unable to get up and was taken by ambulance to  Hospital   At the emergency room they found that I had a UTI, but, could not move my arms and legs.   At that time they called in a neurologist and he thought I might have GBS
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Paraesthesia, Syncope, Urinary tract infection
Clinical narrative: late November I started to have numbness and tingling in my hands and feet, on the morning of December 4 I tried to stand up and collapsed to the floor.  I was unable to get up and was taken by ambulance to  Hospital   At the emergency room they found that I had a UTI, but, could not move my arms and legs.   At that time they called in a neurologist and he thought I might have GBS
Age: 46.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMRV given to a 46 year old pt. Vaccine not recommended for that age. No adverse symptoms. pt was notified.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Cough, Pyrexia, Stridor, Use of accessory respiratory muscles
Clinical narrative: 24 hours later, child came down with high fevers and cough, becoming very barky. Stridor at rest started the next morning and persistent the next day. Child returned to office with heart rate of 185, room air sats of 94%. Retractions seen with access muscle use, and significant inspiratory stridor. Temp of 101.7
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin reaction, Skin warm
Clinical narrative: Patient had PCV 20 last week and came in today. The entire upper arm was red swollen and hot to the touch. Dr. went and looked and stated it was just a localized allergic reaction. Dr. advised patient to take Benadryl and use hydrocortisone cream for itching.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Extensive redness, itching, and pain at injection site.  Skin is warm to the touch and tender.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Pain, Skin warm, Swelling, Tenderness
Clinical narrative: Patient received Flu and Covid vaccines in left arm on 3/3/25.  She presented to pharmacy on 3/6 with complaints of local allergic reaction (pain, redness, swelling, tender, area feels warm to touch).  She did not complain of any fever. She stated taking Tylenol for the pain.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This case is considered as invalid since the country of primary reporter changed at follow-up, determining an incorrect sender's unique case identifier number.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "Covid". The patient date of death was Jan2022. Reported cause of death: "COVID-19". Clinical courses is as follows: patient passed away in Jan2022 after getting the Pfizer covid 19 shot the second one he was diagnosed with covid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  Follow-up (28Feb2025): This is a spontaneous follow-up report received from Pfizer colleague.  Updated information: State and Postal code added in reporter, the country of primary reporter changed at follow-up.  The information on the batch/lot number for (BNT162B2) will be requested and submitted if and when received.  Nullification reason: the country of primary reporter changed at follow-up. A new case [US-PFIZER INC-202500048023] was copied from this case to create with the correct Primary reporter's country; Reported Cause(s) of Death: COVID-19; COVID-19