chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TD, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: potentially receiving Tenivac instead of Adacel with no reported adverse event; Initial information received on 21-Aug-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who experienced potentially receiving Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site and a  dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (Suspension for injection) lot 3CA10C1 ,strength , expiry date was unknown via unknown route in unknown administration site for prophylactic vaccination (Immunization) and potentially receiving tenivac instead of adacel with no reported adverse event (wrong product administered) (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: immediately after administration, it was noted that the vaccine had expired with no reported adverse event; Initial information received on 22-Aug-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 35 years old male patient for whom immediately after administration of RABIES (HDC) VACCINE [IMOVAX RABIES], it was noted that the vaccine had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Aug-2024, the patient received dose 1 of suspect RABIES (HDC) VACCINE, Powder and solvent for suspension for injection, 1 ml (x1) expiry-31-May-2024 lot V1B861M via intramuscular route in unknown administration site for pre-travel prophylaxis (Immunization) (strength unknown), immediately it was noted that the vaccine had expired with no reported adverse event (expired product administered) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: diluted ACTHIB with the wrong diluent, with no reported adverse event; Initial information received on 23-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient for whom diluted HIB (PRP/T) VACCINE [ACT-HIB] with the wrong diluent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2024, the patient received diluted HIB (PRP/T) VACCINE, 0.5 ml (x1) Powder and solvent for solution for injection expiry-28-Feb-2025 lot UJ995AA via intramuscular route in unknown administration site for Immunization (strength unknown) with the wrong diluent, with no reported adverse event (product preparation error) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 62.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PATIENT IS A 62 YEAR OLD FEMALE WHO CAME IN FOR FLUCELVAX. SHE WAS GIVEN THE WRONG FLU SHOT,  HIGH DOSE FLUAD INSTEAD OF FLUCELVAX
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pallor, Somnolence, Vomiting
Clinical narrative: Vomiting, pallor, light-headedness, sleepiness
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, HEPA, PNC15
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This is a medication error report. The pediatric patient received the adult dose of Hep B (Engerix-B) 20mcg/hep B. The error was found during our end of month count. Provider notified, Patients family was called and notified, per patient mother child had no adverse reaction and is doing fine, no changes in status, states playing as usual and has not been sick.  A corrective action plan had been put in place to prevent this from happening again, Plan is as follows. Corrective action plan for vaccine administration error 1. All personnel that administer vaccines will have to review the following videos offered.    2. The refrigeration set up for immunization has been review and the following changes made to decrease the possibility of medication error when administering vaccines. ?  The vaccines are currently on the top shelf of the refrigeration unit and they will remain on top shelf but will be enclosed in a separate container all together. All individual doses will remain in shipping box; however, all doses will be label ADULT. This will help in identifying the vaccine so that it cannot be mistaken for a pediatric dose.  ? pediatric doses will remain in the second and third shelf of refrigeration unit, they will also remain in their shipped box and will have a yellow label indicating pediatric dose.  3. The 5 rights of medication administration are currently used and we have reviewed the process to see how the mistake took place. After further review, we have decided to add an extra step to the verification process. All immunizations will now have a two-point verification process in addition to the 5 rights of medication administration.  the first verification process will be done by staff administering immunization. They will verify 5 rights and inspect the vaccines physically for accuracy, as in pediatric or adult dose. The second verification process will be done by the primary or secondary vaccine coordinator, they will reverify the 5 rights and correct dose pediatric or adult before being administered to the patient.
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Pediarix was given intramuscular in left thigh at 1310.  Patient immediately started crying and redness and warmth was noted to left thigh. Dr. aware and examines patient.  No respiratory distress noted. Oral benadryl and ibuprofen infants drops given, dose per weight.  Benadryl was given at 1345 and ibuprofen was given at 1347. Patient waited with mom in room.  Redness in left thigh improved after receiving  benadryl.  At 1424 patient left via mom's arms and went to ER to be evaluated per patient's mom request.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: Ear discomfort, Pallor, Syncope
Clinical narrative: Patient received a flu shot on 08/30/2024.  She fainted at the front register area after she received her vaccine.  She did not hit anything. Staff rushed to front after a casher informed us in the pharmacy.  When we arrived at the front register, pt. was sitting on a chair, appeared pale.   She was provided a bottle water and a bottle of Sprite.  Consulted mom before vaccine.  Per mom, she had flu shot before, did not have any adverse reaction, did not have history of fainting.  She said pt. has been fine with prior vaccines, she is not afraid of needles.   Mom said she is  anemic.  She had food and has been keeping herself hydrated. Pt. did complained about her ears clogged.   Told mom to stay in the store to make sure pt. is ok before leaving.   They left while we were in the pharmacy documenting this incident.  Called patient at 2pm and left message.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional second dose RSV outside the current Guideline
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient did receive both the doses of Shingrix, and could not remember but on the STC (state registry) it showed due for the second dose of shingrix. After receiving the second dose our system flagged the rx because pt already had both the doses. So accidently, patient received an extra dose of Shingrix.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional second RSV vaccine outside to the Guideline. Patient has not received any treatment as of this moment.
Age: 1.58
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Rash pruritic, Vaccine positive rechallenge
Clinical narrative: Note, for the previous item, we know he got the Hib conjugate and Hep A, but we are unsure of the specific subtype. He gets a rash 1-2 days after the vaccination. The rash lasts for weeks. It is itchy and has been getting worse. So far, the treatment is with antihistamines (which don't seem to be helping anymore) and topical low dose steroid cream (Benadryl). We are also applying Vaseline to help moisturize and protect the skin. He still has the rash currently. Usually it resolves on its own after about 3 or 4 weeks.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injection site nerve damage, Neuralgia
Clinical narrative: Patient states she "felt the needle hit a nerve" and has had nerve pain in her arm and hand ever since. The patient is also experiencing joint pain in her arm and hand.
Age: 84.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: injection site reaction. Pt. experienced swelling, redness , and pain following injection.  Condition started to improve  in 2 days.  At 3 days still red but swelling and pain are starting to recede.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyskinesia, Headache, Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: Woke up with a bad headache and fever 101 When taking shower my whole right side became numb from my right eye to right arm and neck and experiencing uncontrollable muscle spasms that felt like shoulder or neck neck bone was going to come out of their socket I then through myself on the bed face first to try and stop the muscle contractions.I felt I was having a stroke but after laying down for about five minutes it mysteriously stopped and I went to work for a little while then I felt more tingling and went home and it happened again for 5 minutes I called an ambulance but the jerking went away by the time they came.So I?m just monitoring myself
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Woke up with a bad headache and fever 101 When taking shower my whole right side became numb from my right eye to right arm and neck and experiencing uncontrollable muscle spasms that felt like shoulder or neck neck bone was going to come out of their socket I then through myself on the bed face first to try and stop the muscle contractions.I felt I was having a stroke but after laying down for about five minutes it mysteriously stopped and I went to work for a little while then I felt more tingling and went home and it happened again for 5 minutes I called an ambulance but the jerking went away by the time they came.So I?m just monitoring myself
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Fall, Loss of consciousness, Pallor, Syncope
Clinical narrative: I administered the flu vaccine to the patient and he got up and walked  out of the IMZ booth and walked over to his father.  Vaccine administered around 605 pm.  Pt fainted and fell to the floor around 608pm. Pt woke back up, pale in face.  He was laid down and elevated his legs.  He laid for about 2-3 minutes and stated he felt ok.  I had him sit down on the bench outside the pharmacy for 15 minutes.  Provided water and some lifesaver candy.  Asked pt's parents if they wanted to call medic  but they stated they think it was ok and he was fine.  Pt had no physical injuries and was able to walk out of pharmacy.
Age: 83.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient had redness, inflammation, burning at the injection site. She did seek treatment at a walk-in clinic for treatment. She reported the vaccine reaction to the pharmacy today 8/30/24, She said the redness and swelling had dissipated but she was still experiencing a little burning. It was recommended by her provider at the walk in clinic that the patient report the reaction to the pharmacy so they could record it in VAERS.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Pain, Pain in extremity, Pyrexia
Clinical narrative: Within 12 hours of receiving the vaccine, patient began experiencing fever/chills, arm soreness/tenderness, and body aches. Patient applied an ice pack to the injection site and took Tylenol throughout the day, but did not find relief until 23 hours after injection. 47 hours after initial injection, patient discovered a rash around the injection site. Patient applied Benadryl cream to rash and found some improvement.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Within 12 hours of receiving the vaccine, patient began experiencing fever/chills, arm soreness/tenderness, and body aches. Patient applied an ice pack to the injection site and took Tylenol throughout the day, but did not find relief until 23 hours after injection. 47 hours after initial injection, patient discovered a rash around the injection site. Patient applied Benadryl cream to rash and found some improvement.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: INCREASE IN HEART RATE (UP TO 120); FEELING PALPITATION
Age: 40.0
Sex: F
Vaccine: COVID19, FLUR4
Symptoms: Dyspepsia, Dyspnoea, Feeling abnormal, Insomnia, Menstrual disorder
Clinical narrative: Triggered menstrual cycle onset within 24 hours of vaccination even though my period was not due and are always regular. Shortness of breath. Indigestion. Feeling poorly. Insomnia.
Sex: M
Vaccine: VARZOS
Symptoms: Encephalitis herpes, Eye haemorrhage, Herpes zoster oticus, Ill-defined disorder, Neurological symptom
Clinical narrative: Vertigo like symptoms; "the doctors did not know what was wrong with him"; he has had suicidal thoughts that "come and go"; Patient stated that "this vaccine has ruined my life and will cause me to die; he developed herpes zoster virus in his eyes; he developed herpes zoster virus in his brain; he developed herpes zoster virus in his ear; he has developed "dementia like symptoms"; he has bleeding in his one eye that still affects him.; This spontaneous report was received from a male consumer of unknown age reporting on himself.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    In 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route, lot#, and expiration date were not reported) for prophylaxis.         On an unknown date (reported as no specific dates were provided for when patient received vaccine or developed the side effects), the patient developed herpes zoster virus in his eyes (ophthalmic herpes zoster), brain (encephalitis herpes), and ear (herpes zoster oticus). Patient reported that he had developed "dementia like symptoms" (dementia) as well. Patient reported that he had bleeding in his one eye that still affects him (eye haemorrhage). Patient reported that he was hospitalized in 2019 for "vertigo like" symptoms (vertigo) and the doctors did not know what was wrong with him (ill-defined disorder). Patient also stated that he had had suicidal thoughts that "come and go" (suicidal ideation) since receiving zoster vaccine live (ZOSTAVAX). Patient stated that "this vaccine has ruined my life and will cause me to die." (ill-defined disorder).   At the time of reporting, the outcome of eye haemorrhage was reported as not recovered (reported as that still affects him).  The outcome of ophthalmic herpes zoster, encephalitis herpes, herpes zoster oticus, dementia, vertigo, ill-defined disorder, suicidal ideation and ill-defined disorder.  The reporter considered ill-defined disorder (reported as this vaccine has ruined my life and will cause me to die) to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporter considered the events ophthalmic herpes zoster, encephalitis herpes and herpes zoster oticus to be serious as Life threatening. The reporter considered the events ophthalmic herpes zoster, encephalitis herpes, herpes zoster oticus, suicidal ideation and dementia to be serious as medically significant.  Patient stated that this virus was life threatening to him.  No further information was provided by patient. Consent to contact HCP was not given.
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Suicidal ideation
Clinical narrative: Vertigo like symptoms; "the doctors did not know what was wrong with him"; he has had suicidal thoughts that "come and go"; Patient stated that "this vaccine has ruined my life and will cause me to die; he developed herpes zoster virus in his eyes; he developed herpes zoster virus in his brain; he developed herpes zoster virus in his ear; he has developed "dementia like symptoms"; he has bleeding in his one eye that still affects him.; This spontaneous report was received from a male consumer of unknown age reporting on himself.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    In 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, route, lot#, and expiration date were not reported) for prophylaxis.         On an unknown date (reported as no specific dates were provided for when patient received vaccine or developed the side effects), the patient developed herpes zoster virus in his eyes (ophthalmic herpes zoster), brain (encephalitis herpes), and ear (herpes zoster oticus). Patient reported that he had developed "dementia like symptoms" (dementia) as well. Patient reported that he had bleeding in his one eye that still affects him (eye haemorrhage). Patient reported that he was hospitalized in 2019 for "vertigo like" symptoms (vertigo) and the doctors did not know what was wrong with him (ill-defined disorder). Patient also stated that he had had suicidal thoughts that "come and go" (suicidal ideation) since receiving zoster vaccine live (ZOSTAVAX). Patient stated that "this vaccine has ruined my life and will cause me to die." (ill-defined disorder).   At the time of reporting, the outcome of eye haemorrhage was reported as not recovered (reported as that still affects him).  The outcome of ophthalmic herpes zoster, encephalitis herpes, herpes zoster oticus, dementia, vertigo, ill-defined disorder, suicidal ideation and ill-defined disorder.  The reporter considered ill-defined disorder (reported as this vaccine has ruined my life and will cause me to die) to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporter considered the events ophthalmic herpes zoster, encephalitis herpes and herpes zoster oticus to be serious as Life threatening. The reporter considered the events ophthalmic herpes zoster, encephalitis herpes, herpes zoster oticus, suicidal ideation and dementia to be serious as medically significant.  Patient stated that this virus was life threatening to him.  No further information was provided by patient. Consent to contact HCP was not given.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no symptoms reported; Patient received an extra dose of the vaccine in error. No symptoms reported.; This spontaneous report was received from a medical assistant concerning a 6-year-old unspecified gender patient. The patient's historical vaccinations included (measles virus (edmonston) live attenuated [chick embryo cells], mumps virus (jeryl lynn) live [chick embryo cells], rubella virus (wistar ra 27/3) live attenuated [wi-38 cells]) (M-M-R II) and varicella virus (oka/merck) live attenuated [mrc-5 cells] (VARIVAX) . Concurrent conditions or concomitant therapies were not reported.  On 08-AUG-2023 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) injection at a dose of 0.5 milliliter, lot number X011437 which has been verified to be valid, expiration date reported and validated as 18-JUL-2024 (strength, route of administration, and anatomical location were not provided). The medical assistant reported that their office uses a system, to document patient's health records, which stated that the patient was due for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live vaccination (PROQUAD), therefore, on 14-AUG-2024, the patient received an extra dose of the vaccine at a dose of 0.5 milliliter, lot number X025823 which has been verified to be valid, expiration date reported and validated as 29-APR-2025 (strength, route of administration, and anatomical location were not provided). After the patient was administered the extra dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live vaccination (PROQUAD) the medical assistant checked the patient's health records against their EMR system and confirmed that patient received an extra dose of the vaccine in error (extra dose administered). No symptoms reported.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Vestibular disorder
Clinical narrative: Bells Palsy; vestibular issues that caused her to be off balance and dizzy; This spontaneous case was reported by a non-health professional and describes the occurrence of BELL'S PALSY (Bells Palsy) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 05-Mar-2023, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant) and VESTIBULAR DISORDER (vestibular issues that caused her to be off balance and dizzy). At the time of the report, BELL'S PALSY (Bells Palsy) and VESTIBULAR DISORDER (vestibular issues that caused her to be off balance and dizzy) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant and treatment medication were reported.  Company comment:  This spontaneous case concerns a patient (unknown age and gender), with no medical history reported, who received a dose with Spikevax Covid-19 vaccine NOS and experienced the expected, serious (medically significant) AESI Bell´s palsy. Latency cannot be properly assessed since vaccination date was not provided. The report stated that the patient experienced Bell's palsy and vestibular issues, which caused imbalance and dizziness. The outcome of the event was unknown. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax Covid-19 vaccine NOS is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Body temperature decreased, Chills, Cough, Dyspnoea, Hypoaesthesia
Clinical narrative: First, sudden onset shortness of breath. Couldn't take deep breaths, got really hot, felt like I was trying to breathe in a hot humid room, wheezing, coughing. Lasted about 10 minutes. About a half hour later, chills. Teeth chattering, whole body shaking, fingers went a little numb/tingly, body temperature kept dropped 2 degrees (to 96). Lastly, got in bed under multiple blankets and heating pad, fever set in. Temp got to 100.7 before I started peeling off blankets. Sweat throughout the night. Felt mostly back to normal after 12 hours (7pm onset to 7am wake up)
Age: 34.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Paraesthesia, Pyrexia, Tremor, Wheezing
Clinical narrative: First, sudden onset shortness of breath. Couldn't take deep breaths, got really hot, felt like I was trying to breathe in a hot humid room, wheezing, coughing. Lasted about 10 minutes. About a half hour later, chills. Teeth chattering, whole body shaking, fingers went a little numb/tingly, body temperature kept dropped 2 degrees (to 96). Lastly, got in bed under multiple blankets and heating pad, fever set in. Temp got to 100.7 before I started peeling off blankets. Sweat throughout the night. Felt mostly back to normal after 12 hours (7pm onset to 7am wake up)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Carditis, Electrocardiogram normal, Pain, Tinnitus
Clinical narrative: It hurt really bad for days. Within a week my heart swelled up really badly and I could feel it sagging in my chest. I now also have a loud ringing in my ears that I never experienced before.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Decreased appetite, Injection site pain, Nausea
Clinical narrative: Employee did have soreness on Left injection site. Donor also had severe nausea and stomach pain to the point she could not eat or drink anything, Did not intake food for 2 days. Forcefully took water.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Headache, Injection site erythema
Clinical narrative: Redness and soreness at injection site, joint pain, fatigue, muscle pain, headache, stomach pain. Redness 6 cm X 5 cm at injection site. Heat at site, swelling at site. 08/30/2024 15:00
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Redness and soreness at injection site, joint pain, fatigue, muscle pain, headache, stomach pain. Redness 6 cm X 5 cm at injection site. Heat at site, swelling at site. 08/30/2024 15:00
Age: 64.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Chills and nausea resulting in vomiting
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED A SECOND SHOT 1 YEAR APART AT SEPARATE LOCATIONS.  FOUND LOOKING AT WEBSITE FOR IMMUNIZATIONS
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia
Clinical narrative: Increasing hoarseness  for about 1-2 minutes.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness
Clinical narrative: Patient started feeling dizzy, light headed and clammy about 15 to 30 minutes after receiving  vaccine
Age: 31.0
Sex: F
Vaccine: FLUR4, HEP, VARCEL
Symptoms: Syringe issue, Underdose
Clinical narrative: PATIENT DID NOT RECEIVE FULL DOSE OF  HEPLISAV-B VACCINE SECOND DOSE DUE TO ADMINISTRATION EVENT (MALFUNCTION OF SYRINGE)
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Condition aggravated, Fibromyalgia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: I noticed about 1-2hrs after vaccine booster administered. My nose started tingling. Then it slowly began to turn numb. The tingling spread to my upper lip, then to the tops of my cheaks. By the end of the day, most of the normal sensation returned. But it is 10:58am the next day (Aug 31st) and I still have very slight tingling in the bulb of my nose.  My nose has never tingled/gone numb from a vaccine before. I am  also experiencing a lot of joint pain/fibromyalgia flare up. But for me this happens after every covid vaccine so far. I'm not experiencing the debilitating headache I've gotten with all previous Pfizer covid boosters. So, that is different. The other vaccine was a flu vaccine. I don't know which one. I received covid booster in one arm and flu vaccine in the other. In response, I contacted my doctor by email. I haven't taken any other actions.
Age: 40.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Paraesthesia oral
Clinical narrative: I noticed about 1-2hrs after vaccine booster administered. My nose started tingling. Then it slowly began to turn numb. The tingling spread to my upper lip, then to the tops of my cheaks. By the end of the day, most of the normal sensation returned. But it is 10:58am the next day (Aug 31st) and I still have very slight tingling in the bulb of my nose.  My nose has never tingled/gone numb from a vaccine before. I am  also experiencing a lot of joint pain/fibromyalgia flare up. But for me this happens after every covid vaccine so far. I'm not experiencing the debilitating headache I've gotten with all previous Pfizer covid boosters. So, that is different. The other vaccine was a flu vaccine. I don't know which one. I received covid booster in one arm and flu vaccine in the other. In response, I contacted my doctor by email. I haven't taken any other actions.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Epistaxis, Fatigue, Night sweats, Syncope
Clinical narrative: Patient reported fatigue and sweating in the middle of the night. When she got up to use the bathroom, she fainted on the ground. She later woke up with nose bleeding and bruises on her nose. When she call me she felt " 80% better". She has not checked the record of her defibrillator, but will contact her cardiologist.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Asthenia, Autonomic nervous system imbalance, Cytokine increased, Dyspnoea
Clinical narrative: There was not an acute reaction to the vaccine, but within one week of the 2nd dose in the series symptoms of extreme fatigue, high heartrate, difficulty breathing/shortness of breath, heat intolerance, blood pooling, fainting occured. Within 3 months of the vaccine original symptoms persisted and new symptoms of gastrointestinal pain and nausea began and have persisted. All symptoms persist and are debilitating. Echocardiogram(1/22; 7/15/22 Possible dilated aortic root), Allergy testing/bloodwork (varying dates low vitamin D, low ferritin, high cytokines), Tilt Table Testing  (10/26/22; 9/6/23 confirmed diagnosis of Autonomic Dysfunction/POTS)
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram ambulatory abnormal, Electrocardiogram normal, Fatigue, Gastrointestinal pain
Clinical narrative: There was not an acute reaction to the vaccine, but within one week of the 2nd dose in the series symptoms of extreme fatigue, high heartrate, difficulty breathing/shortness of breath, heat intolerance, blood pooling, fainting occured. Within 3 months of the vaccine original symptoms persisted and new symptoms of gastrointestinal pain and nausea began and have persisted. All symptoms persist and are debilitating. Echocardiogram(1/22; 7/15/22 Possible dilated aortic root), Allergy testing/bloodwork (varying dates low vitamin D, low ferritin, high cytokines), Tilt Table Testing  (10/26/22; 9/6/23 confirmed diagnosis of Autonomic Dysfunction/POTS)
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Magnetic resonance imaging head normal, Nausea, Peripheral venous disease, Postural orthostatic tachycardia syndrome
Clinical narrative: There was not an acute reaction to the vaccine, but within one week of the 2nd dose in the series symptoms of extreme fatigue, high heartrate, difficulty breathing/shortness of breath, heat intolerance, blood pooling, fainting occured. Within 3 months of the vaccine original symptoms persisted and new symptoms of gastrointestinal pain and nausea began and have persisted. All symptoms persist and are debilitating. Echocardiogram(1/22; 7/15/22 Possible dilated aortic root), Allergy testing/bloodwork (varying dates low vitamin D, low ferritin, high cytokines), Tilt Table Testing  (10/26/22; 9/6/23 confirmed diagnosis of Autonomic Dysfunction/POTS)
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin decreased, Syncope, Temperature intolerance, Tilt table test positive, Vitamin D decreased
Clinical narrative: There was not an acute reaction to the vaccine, but within one week of the 2nd dose in the series symptoms of extreme fatigue, high heartrate, difficulty breathing/shortness of breath, heat intolerance, blood pooling, fainting occured. Within 3 months of the vaccine original symptoms persisted and new symptoms of gastrointestinal pain and nausea began and have persisted. All symptoms persist and are debilitating. Echocardiogram(1/22; 7/15/22 Possible dilated aortic root), Allergy testing/bloodwork (varying dates low vitamin D, low ferritin, high cytokines), Tilt Table Testing  (10/26/22; 9/6/23 confirmed diagnosis of Autonomic Dysfunction/POTS)
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient experienced redness and swelling on his left arm for a few days. Took ibuprofen and antihistamine to help with the redness and swelling. Adverse events went away after a few days.  Patient states they feel fine and no other issues.
Age: 7.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult Phizer covid vaccine (ndc 00069-2432-10) administered to seven year old.
Age: 7.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Fatigue, Incorrect dose administered, Pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Adult Phizer covid vaccine (ndc 00069-2432-10) administered to seven year old.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Pyrexia, Rash, Rash vesicular
Clinical narrative: 2 weeks after vaccination chicken pox like rash all over body with low grade fever and dry cough
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Approximately 6 hours after the shot, I developed a headache, nausea and substantial fatigue, as I expected was possible. However, I woke at 3:00 a.m. with chills, severe joint pain all over my body, and severe headache. Tylenol did little to reliev the episode. Chills ans shivering lasted on and off for about 3 hours. The headache subsided some also around 6:00 a.m., but it never completely stopped. By  2:30 P.m. on 08/31, the headache worsened, tinnitus started, and severe pain in all of my joints now has persisted for about 90 minutes in spite of taking Tylenol at 3:00 p.m.  No fever, but mild vertigo and nausea are present.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Vertigo
Clinical narrative: Approximately 6 hours after the shot, I developed a headache, nausea and substantial fatigue, as I expected was possible. However, I woke at 3:00 a.m. with chills, severe joint pain all over my body, and severe headache. Tylenol did little to reliev the episode. Chills ans shivering lasted on and off for about 3 hours. The headache subsided some also around 6:00 a.m., but it never completely stopped. By  2:30 P.m. on 08/31, the headache worsened, tinnitus started, and severe pain in all of my joints now has persisted for about 90 minutes in spite of taking Tylenol at 3:00 p.m.  No fever, but mild vertigo and nausea are present.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pruritus
Clinical narrative: Patient came 08/31, left arm was swollen from elbow up and red. She said arm was itchy and had some pain; She says symptoms started Wednesday 08/28. Vaccine was administered 08/24 for Prevnar 20, She stated reaction is getting better and arm was more swollen yesterday; She was already advised to take Ibuprofen. I advised she may be sensitive to Prevnar vaccine or possible allergy and to take Benadryl and see physician.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Condition aggravated, Heart rate increased
Clinical narrative: Raised blood pressure, heart rate spikes at night.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Pharmacy prepared an MMR vaccine for the patient but mom notified us now today 8-31-24 that the vaccine should've been for meningitis B. School notified mom that the forms she reported to the school for patient's vaccination history was incomplete, as he received MMR per the immunization consent form, instead of meningitis B. Pharmacy team's records indicate records of giving MMR and no mentioning of meningitis B. Not sure if this was a communication error, but regardless patient received a vaccine they didn't request. He had been previously vaccinated in 2013 and 2017 per vaccine registry.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness, swelling, pain at or near injection site  tx: antihistamine, topical steroid, ibuprofen
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Fall, Feeling abnormal
Clinical narrative: Patient said she did not feel the best after receiving her flucelvax vaccine and said she wanted to sit in the vaccination chair until her grandfather came in for his vaccine.  I told her that was fine she could sit as long as she wanted.  After a few minutes (maybe) mom suggested that she move to a different chair so her grandfather could get in for his vaccines.  I was assisting another patient at the register and heard the patient fall.  I paged for an MIC and told the mother I would call 911 but the daughter (patient) was already up and demanded I did not.  Mother was made aware that it was her decision to make and she opted for me not to call 911 and after about 10 minutes said she was driving her daughter to the walk in to make sure she was ok.
Age: 77.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Neurological symptom
Clinical narrative: patient reported neurological illness that the prescriber says was caused by receiving shingrix and arexvy
Age: 15.0
Sex: M
Vaccine: FLUC4
Symptoms: Syncope
Clinical narrative: Patient fainted approximately 15 to 20 minutes after receiving the 2024-2024 Flucelvax immunization.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Pain
Clinical narrative: High fever, intense body aches (joint and muscular), extreme chills/sweats
Age: 41.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Pyrexia
Clinical narrative: High fever, intense body aches (joint and muscular), extreme chills/sweats
Age: 19.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Patient  reported tightness in chest and trouble breathing about 15 minutes after administration of vaccinations. The patient appeared sweaty, but had normal pulse and appeared to have normal breathing however the patient reported trouble breathing. Patient then reported dizziness and after instructing patient to move to the floor one dose of epinephrine 0.3mg was administered into left thigh and 911 was called, Ems arrived to transport patient to hospital.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Extreme back pain at #7 to 8. Restless, entire body aches, fever, sweating. Felt like shingles again.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: Extreme back pain at #7 to 8. Restless, entire body aches, fever, sweating. Felt like shingles again.
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Patient received two vaccines on 04/13/24, one in each arm. Patient reports feeling pain at the injection site of the right arm, the day of the vaccinations. The pain progressively worsened over the following days/weeks, patient further reports stiffness and limited range of motion in the affected arm that persist through today.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Asthma, Condition aggravated, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of the injection site and then asthma exacerbation.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, Redness, Erythema, pain at injection site
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: PT HAS SAID THAT ON HER RIGHT ELBOW SHE HAS DVELOPED BRUISING. HER INJECTION SITE IS CLEAR. NO REDNESS OR SWELLING THERE. PT HAD HIT HER ELBOW WEEK AND HALF AGO BUT DIDN'T NOTICE ANY BRUISING THAT TIME
Age: 78.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Brain fog, Fatigue, Pyrexia
Clinical narrative: (Covid Comirnaty 24-25 version; shingrix dose 1); PT STATES THAT AFTER GETTING SHINGRIX AND UPDATED COVID ON 8/28/24, SHE STATES THE NEXT DAY SHE FELT FEVERISH, EXTREMELY TIRED (TOOK NAPS THROUGHOUT THE DAY FOR SEVERAL HOURS, AND FELT "BRAIN FOG", INABILITY TO COMPREHEND READING, AND INABILITY TO FIND HER WORDS (TRYING TO THINK OF THE WORD SHINGLES AND IT WAS COMING OUT SKITTLES, WORRIED ABOUT DRIVING DUE TO SAFETY. SHE DID NOT SEEK MEDICAL CARE, IS RELATIVELY HEALTHY, DENIES ANY S/S OF STROKE (FACIAL DROOPING, WEAKNESS OF LIMBS). SHE STATES SHE IS FEELING 97%  BACK TO NORMAL NOW. I ADVISED HER TO SEEK MEDICAL ATTENTION IF SXS GET WORSE OR DONT GET BETTER; ADVISED HER TO FOLLOW UP WITH PCP ASAP REGARDLESS OF FEELING BETTER.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: the next morning pt went to the hospital and was diagnosed with a-fib and was sent home on eliquis
Age: 12.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Fall, Laboratory test normal, Muscle tightness, Syncope, Unresponsive to stimuli
Clinical narrative: Patient had received vaccines at approximately 11:54 AM and had fainted and fallen on floor at approximately 11:56 AM. Patient was unresponsive to name for about 3-5 seconds with eyes partially open and muscles tensing then became alert and responsive.  Patient was responsive to questions for remainder of event. Blood pressure was 105/ 60 and pulse was 124 at about 11: 57 AM. Blood pressure was 104/ 59 and pulse was 104 at about 12:05 PM. EMS arrived at about 12:11 PM and assessed patient. Patient was able to walk a few steps to stretcher and EMS departed from pharmacy at about 12:18 PM. Pharmacist followed up with parent at about 3:50 PM. Mother stated that ER staff said patient would be discharged from the ER later that day and stated that lab tests and assessments ordered by ER staff showed no indication of a new health issue or anything else being wrong.
Age: 18.0
Sex: F
Vaccine: HEP, RV1, UNK
Symptoms: Crying, Emotional distress
Clinical narrative: My daughter received her 2 month shots on 8/28/2024, that evening she proceeded to scream non stop for hours upon hours despite efforts from multiple family members to attempt to help her; her demeanor and way she normally holds herself has changed. She is upset and crying more, even with no real cause.  Today is 8/31/2024, she is still having issues with being uncausably upset
Age: 41.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Asthenia, Cardiac monitoring, Dizziness, Gait disturbance, Heart rate decreased
Clinical narrative: RPH ADMINISTERED COMIRNATY IN LEFT ARM AND THEN FLUBLOK IN PT'S RIGHT ARM. PT WAS OKAY AFTER COVID SHOT AND THEN ACTED LIKE THE FLU SHOT HURT. THE PT IMMEDIATELY STARTED LEANING FORWARD IN HIS CHAIR, CLOSING HIS EYS AND RUBBING HIS FACE. THE COLOR IN PT'S FACE DRAINED. RPH REQUESTED HELP. OUR TEAM GAVE PT COLD WATER BOTTLE, OFFERED SNACKS TO INCREASE BLOOD SUGAR (PT DECLINED), BROUGHT A FAN, MOVED THE PT TO FRESHER AIR. PT APPEARED WEAK AND HIS MUSCLES WERE LIMP. PT LAYED ON THE GROUND WITH HELP FROM OTHER RPH. PT'S COLOR RETURNED SLIGHTLY; PT SAID HE FELT A BIT BETTER. PT SAT UP AND AFTER A SHORT TIME GOT BACK IN A CHAIR. PHARMACY STAFF STAYED WITH PT THE WHOLE TIME. PT STOOD UP AND TRIED TO WALK TO THE BATHROOM; HIS DIZZINESS RETURNED AND PT STARTED TO GO DOWN TO THE GROUND. PHARMACY TEAM AND A BYSTANDER HELPED PT GET TO THE GROUND. RPH PUT PT IN RECOVERY POSITION. RPH INSTRUCTED TECHNICIAN TO CALL 911 AND STORE MANAGEMENT. RPH MONITORED PT UNTIL EMT'S ARRIVED AND TOOK OVER. EMTS ASSESSED PT. HIS HEART RATE WAS LOW AND IN THE 40'S. AND HIS COLOR WAS POOR. EMTS TRANSPORTED PT TO EMERGENCY ROOM.
Age: 41.0
Sex: M
Vaccine: COVID19, FLUR4
Symptoms: Hypotonia, Immediate post-injection reaction, Injection site pain, Pallor, Posture abnormal
Clinical narrative: RPH ADMINISTERED COMIRNATY IN LEFT ARM AND THEN FLUBLOK IN PT'S RIGHT ARM. PT WAS OKAY AFTER COVID SHOT AND THEN ACTED LIKE THE FLU SHOT HURT. THE PT IMMEDIATELY STARTED LEANING FORWARD IN HIS CHAIR, CLOSING HIS EYS AND RUBBING HIS FACE. THE COLOR IN PT'S FACE DRAINED. RPH REQUESTED HELP. OUR TEAM GAVE PT COLD WATER BOTTLE, OFFERED SNACKS TO INCREASE BLOOD SUGAR (PT DECLINED), BROUGHT A FAN, MOVED THE PT TO FRESHER AIR. PT APPEARED WEAK AND HIS MUSCLES WERE LIMP. PT LAYED ON THE GROUND WITH HELP FROM OTHER RPH. PT'S COLOR RETURNED SLIGHTLY; PT SAID HE FELT A BIT BETTER. PT SAT UP AND AFTER A SHORT TIME GOT BACK IN A CHAIR. PHARMACY STAFF STAYED WITH PT THE WHOLE TIME. PT STOOD UP AND TRIED TO WALK TO THE BATHROOM; HIS DIZZINESS RETURNED AND PT STARTED TO GO DOWN TO THE GROUND. PHARMACY TEAM AND A BYSTANDER HELPED PT GET TO THE GROUND. RPH PUT PT IN RECOVERY POSITION. RPH INSTRUCTED TECHNICIAN TO CALL 911 AND STORE MANAGEMENT. RPH MONITORED PT UNTIL EMT'S ARRIVED AND TOOK OVER. EMTS ASSESSED PT. HIS HEART RATE WAS LOW AND IN THE 40'S. AND HIS COLOR WAS POOR. EMTS TRANSPORTED PT TO EMERGENCY ROOM.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Vaccination site rash
Clinical narrative: pt reports getting rash around the arm of vaccination site
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Feeling hot, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Patient experienced syncope and shaking that lasted about 3 seconds. Post-syncope, patient was dizzy, nauseous, flushed, warm, and sweating. This lasted for about 10-15 minutes until EMT staff arrived to take the patient to the hospital for observation/treatment.
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Syncope, Tremor
Clinical narrative: Patient experienced syncope and shaking that lasted about 3 seconds. Post-syncope, patient was dizzy, nauseous, flushed, warm, and sweating. This lasted for about 10-15 minutes until EMT staff arrived to take the patient to the hospital for observation/treatment.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Delivery, Exposure during pregnancy, Psoriasis, Skin lesion
Clinical narrative: I developed psoriasis on my shins and elbows and scalp around six to eight months after receiving the second dose. The only reason I had to put oct 04 2022 for the date of symptoms developed is because that corresponds with the date of a lab where they finally tested the tissue via biopsy. My son was born and is normal and is healthy. His birth weight was approximately 8lbs, 9oz.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling, Urticaria
Clinical narrative: Rash, swelling at site of injection and hives on arm and mostly on left side of body.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: no adverse event until the last:  full body rash, itching, very uncomfortable, no diabetic reaction