chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: large redness area slightly swollen and patient was seen at ER at local hospital. She was told she's having cellulitis and being treated with Doxycycline and Ibuprofen. Two days later, she mentioned that the redness spread and was treated at the hospital with IV antibiotics.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: My arm swelled up and painful, then I developed rashes on my arms, legs, and stomach. and my right leg is painful.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: Below is statement from emergency room report :                                                                                                                                                                                        " Medical Decision Making 4 yo previously healthy fully vaccinated F who presents with 2 days of blisters and erythema, induration, and warmth to left upper extremity following vaccine administration. On exam, she has nearly circumferential erythema of the left upper extremity with area of induration and few blisters, 1 of which has been denuded, the entire area warm to touch.  Overall most consistent with cellulitis.  -Considered abscess but lack of fluctuance points against. -Considered sepsis/bacteremia but well appearance, lack of fever, normal perfusion and MS point against. -Considered compartment syndrome given near circumferential nature of cellulitis but compartments still soft, nvi. -Considered MRSA but no h/o such and no fhx recurrent boils. -Considered anaphylaxis but isolated rash to distinct area of arm with no other s/s points against. -Considered varicella or measles given recent vaccine administration but distribution and appearance are not consistent with either rash.  Labs were considered but not performed given low suspicion for sepsis/bacteremia and no GI sx to suggest electrolyte abnormality, so these were thought to not change clinical management.  Imaging (US soft tissue) was considered but not performed given low suspicion for abscess at this time.  Reassured family of low concern for reaction or allergy to vaccine contents given localized distribution, no signs of anaphylaxis.  Plan: - Given allergy to Keflex, will prescribe clindamycin for 5-day course per IDMP. First Dose given in ED. - Borders of erythema drawn with pen -May give Tylenol or ibuprofen for discomfort or fever -Strict return precautions discussed, including worsening erythema outside the borders of the outline, pain, induration, fever despite antibiotics. Family agreeable with plan, all questions answered"
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes simplex, Inflammation, Malaise, Mobility decreased
Clinical narrative: After 2 hours arm begin to show signs of redness.  Approximately 24 hours had outbreak of HSV2 .  Arm swollen from shoulder to elbow, inflamed and swore.  Difficulty in moving arm in any motion.  Also patient says she had sore throat and not very well.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain in extremity, Peripheral swelling
Clinical narrative: After 2 hours arm begin to show signs of redness.  Approximately 24 hours had outbreak of HSV2 .  Arm swollen from shoulder to elbow, inflamed and swore.  Difficulty in moving arm in any motion.  Also patient says she had sore throat and not very well.
Age: 11.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: pt was due for 3 vaccines today, Tdap/HPV and Men A. Pt came in for a WCC with Brother who was also due for vaccines. while I was preparing vaccines there was a mistake and Men A was ordered as Menveo instead of the MenQuadfi which confused me.  once it was fixed, I made sure Lot # was in for every vaccine, I grabbed both trays in which the vaccines were in and walked into room, I verified DOB and sat Pt down and proceeded to give the 2 vaccines ( MenA/Men B). my mistake was not verifying again with mom the vaccines each pt was getting. I was overwhelmed already that it flew over my head and made the mistake in not verifying first. it is my first time working in this location and I was stressed out in where everything is at that I forgot to verify that one important thing before giving vaccine. after I realized what had happened, I stopped what I was doing and told mom I was going to step out for a min. i informed my coworker on what had happened, and doctor was informed right away too. the doctor then told me to explain to mom that Men B giving early was not going to hurt Pt, in which I apologized and informed pt Mom. Mom was in a rush and wanted to wait on pt getting HPV and Tdap for another day, I apologized and assured pt mom again that giving Men B early was not a problem. Pt mom agreed in understanding and asked if it was ok to checkout now.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Cyanosis, Lethargy
Clinical narrative: 15min post vaccination very lethargic, cyanotic
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Irritability, Pyrexia, Somnolence
Clinical narrative: Fever (highest recorded temp was 102.7 F) lasting at least 72 hours, with irritability, loss of appetite, and sleepiness accompanying. Treating with Motrin and Tylenol.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Infantile vomiting, Underdose
Clinical narrative: While giving the oral Rotarix, baby began to spit up a little bit. We stopped administering and cleaned spit up and began again. Baby began spit up more than the first time. Medical assistant asked mom if she had fed baby before coming in and she stated no, We then stopped administering completely and notified provider about the adverse reaction. Provider went back into exam room to assess the patient. Pt was doing well and left clinic 15 min later.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 24 hours after the meningitis B vaccine, my son's arm at the injection site was very red, raised, and it spread to an area approximately 4" wide x 8" long, and he complained of discomfort and soreness. Then 36-38 hours after he complained of an excruciating headache. The vaccine was Tuesday afternoon, he missed school  yesterday and today. He is in bed. And says his head hurts worse when he sits up. Doctor suggested alternating advil and tylenol, which we are doing. And he is icing his head.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Loss of personal independence in daily activities
Clinical narrative: 24 hours after the meningitis B vaccine, my son's arm at the injection site was very red, raised, and it spread to an area approximately 4" wide x 8" long, and he complained of discomfort and soreness. Then 36-38 hours after he complained of an excruciating headache. The vaccine was Tuesday afternoon, he missed school  yesterday and today. He is in bed. And says his head hurts worse when he sits up. Doctor suggested alternating advil and tylenol, which we are doing. And he is icing his head.
Age: 60.0
Sex: F
Vaccine: YF
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Patient experienced hives on inner elbows and a prickly feeling. Was prescribed steroidal cream which helped a little bit
Age: 0.5
Sex: F
Vaccine: DTAPIPV, PNC15
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given Kinrix vaccine and should have been given Vaxelis vaccine. No adverse event reported by patient family.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Condition aggravated, Neck pain
Clinical narrative: Patient received HPV vaccine on 3/25/25. At that visit, she was also seen for chronic right neck and shoulder pain and a PT referral was sent for the patient. On 4/2/25, the patient was seen by PT and also sent in a message to the provider asking if the HPV vaccine could have anything to do with the increased pain that she was having. The provider said that it was unlikely and sent in a steroid for the patient and told her to continue with PT. Today, the physical therapist called me to ask if it could be related to the vaccine as the patient continues to have pain and decreased ROM. The nurse involved does not remember giving the vaccine but states she is always careful about site location.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Pyrexia, Rash, Respiratory tract congestion, Skin discolouration
Clinical narrative: Pt presents to clinic on 04/16/2025with rash on his back, the bumps on his back are purple open blisters, he has had a fever along with congestion. Mom wanted treatment, acyclovir 200 mg/5 mL suspension for 5 days. He returned to clinic on 05/02/2025 mom states his rash had gone away until 3 days ago it returned and is worse than before he also is running a fever again with congestion. cephalexin 250 mg/5 mL suspension 7days and acyclovir 200 mg/5 mL suspension for 5 days were prescribed at todays visit.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Febrile convulsion
Clinical narrative: 12moM here for evaluation after febrile seizure. History is consistent with simple febrile seizure. Reviewed the natural history of febrile seizure, including risk of recurrence of febrile seizure and risk of development of lifetime seizure disorder. Reviewed what to do if this happens again.  Source of the fever is possibly the vaccines given yesterday, specifically MMR is known to be associated with febrile seizure. Reviewed with mom that it is still recommended that he receive this risk as the benefit of immunity against measles outweighs the risks of a self-contained febrile seizure with no adverse long term effects. Will report this occurrence to VAERS.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: mmr vaccine was given to the correct pt., the correct vaccine/medication, the correct route, no allergies or side effects to pt. The error was the mmr vaccine was expired (lot # X008385, expired on 03/21/25)  & given on date of service given which was, 03/21/25.
Age: 0.75
Sex: M
Vaccine: MMR
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site urticaria, Rash macular
Clinical narrative: MMR vaccine administered IM in Right Thigh at 1018. Approximately 15 minutes later Mother of patient started noticing some redness and hives in face and at injection site.  When I assessed the patient, redness/blotchiness noted in face and redness and large induration noted in Right thigh where injection was given, approximately 5x6cm in size. Patient acting fine, no SOB, wheezing, vomiting, or hives in any other areas noted.  Oxygen saturation at 100% on room air, HR 126. At approximately 1045 Diphenhydramine 2.5mL was administered orally per Dr.'s verbal order. Patient tolerated well.  After 15 minutes of Diphenhydramine administration, facial redness and blotchiness resolved and redness and induration in thigh still present but decreasing in size. No other signs or symptoms noted.  Dr. assessed patient and discharged them with a referral to an Allergy.
Age: 0.75
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: MMR vaccine administered IM in Right Thigh at 1018. Approximately 15 minutes later Mother of patient started noticing some redness and hives in face and at injection site.  When I assessed the patient, redness/blotchiness noted in face and redness and large induration noted in Right thigh where injection was given, approximately 5x6cm in size. Patient acting fine, no SOB, wheezing, vomiting, or hives in any other areas noted.  Oxygen saturation at 100% on room air, HR 126. At approximately 1045 Diphenhydramine 2.5mL was administered orally per Dr.'s verbal order. Patient tolerated well.  After 15 minutes of Diphenhydramine administration, facial redness and blotchiness resolved and redness and induration in thigh still present but decreasing in size. No other signs or symptoms noted.  Dr. assessed patient and discharged them with a referral to an Allergy.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Malaise, Mobility decreased, Pain
Clinical narrative: Pt states has severe pain around waist area.  Pt states struggled to walk.  He felt "too sick to go to the doctor."  Pt stated he felt "almost paralyzed from waist down for 2 days."
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Cardiac function test normal, Chest pain, Computerised tomogram abdomen abnormal
Clinical narrative: Awoke at midnight April 13th with acute chest pain and trouble breathing, taken to Medical Center ED-  cardiac workup completed with no significant findings, discharged home. Went back to sleep for several hours, awoke around 9am with severe abdominal paina and vomiting. Went back to ER at Medical Center where CT scan was done for suspected cholecystitis - found severe acute pancreatitis with 90% necrosis of the pancreas. By Monday at midnight was in multi organ failure and on a ventilator.  Doctors repeatedly stressing they could not determine what caused - no history of alcohol abuse or evidence gallstone
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Intensive care, Laboratory test, Mechanical ventilation, Multiple organ dysfunction syndrome
Clinical narrative: Awoke at midnight April 13th with acute chest pain and trouble breathing, taken to Medical Center ED-  cardiac workup completed with no significant findings, discharged home. Went back to sleep for several hours, awoke around 9am with severe abdominal paina and vomiting. Went back to ER at Medical Center where CT scan was done for suspected cholecystitis - found severe acute pancreatitis with 90% necrosis of the pancreas. By Monday at midnight was in multi organ failure and on a ventilator.  Doctors repeatedly stressing they could not determine what caused - no history of alcohol abuse or evidence gallstone
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis acute, Pancreatitis necrotising, Sleep disorder, Vomiting
Clinical narrative: Awoke at midnight April 13th with acute chest pain and trouble breathing, taken to Medical Center ED-  cardiac workup completed with no significant findings, discharged home. Went back to sleep for several hours, awoke around 9am with severe abdominal paina and vomiting. Went back to ER at Medical Center where CT scan was done for suspected cholecystitis - found severe acute pancreatitis with 90% necrosis of the pancreas. By Monday at midnight was in multi organ failure and on a ventilator.  Doctors repeatedly stressing they could not determine what caused - no history of alcohol abuse or evidence gallstone
Age: 66.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Deep vein thrombosis, Dyspnoea, Pulmonary embolism, Thromboembolectomy
Clinical narrative: Patient informed after her last dose of Spikevax (10/21/2024) she experienced shortness of breath that began on 10/31/24 and resulted in her hospitalization on 11/01/24, during which she underwent a procedure to remove a saddle pulmonary embolism and received further treatment for DVT in one leg. She stated that the doctors at the hospital felt that the clot had originated in her leg.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects but patient had written in chart receiving Remicade IV every 8 weeks so should not have been administered. Luckily, she missed her last infusion and stated that it's been 3 months since last Remicade dose. Ideally, she would not have received until full 6 months after last dose. She was instructed to monitor for any adverse reaction or signs and symptoms of varicella infection. She wa also instructed to let her treating doctor that she received a live vaccine today.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Injection site cellulitis, Malaise, Respiratory tract congestion
Clinical narrative: Pt states that she started not feeling well the next morning. Pt reports waking up sweating along with having a headache and congestion. Pt went to ER after dealing with symptoms for 3 days. Pt dx with cellulitis at the site of the injection. Pt given abx (cephalexin). Pt aware to complete full dose of abx.
Age: 0.58
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE to report. Patient was inadvertently given a dose of Rotateq at the age of 7 months when he had not received it previously due to not starting it before 15 weeks of age.
Age: 30.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Proquad was given instead of MMR
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Blood glucose normal, Blood pressure decreased, Chills, Dizziness
Clinical narrative: Fainted for a few seconds, went pale, blood pressure dropped, dizzy, chills. As the says passed, she developed arm pain, redness and tender at couch on right arm and swollen around the shot area, neck pain ,headaches, low energy.  Parent took patient to ER for further evaluation.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Electrocardiogram normal, Headache, Human chorionic gonadotropin negative, Injection site pain, Injection site swelling
Clinical narrative: Fainted for a few seconds, went pale, blood pressure dropped, dizzy, chills. As the says passed, she developed arm pain, redness and tender at couch on right arm and swollen around the shot area, neck pain ,headaches, low energy.  Parent took patient to ER for further evaluation.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Neck pain, Pallor, Syncope
Clinical narrative: Fainted for a few seconds, went pale, blood pressure dropped, dizzy, chills. As the says passed, she developed arm pain, redness and tender at couch on right arm and swollen around the shot area, neck pain ,headaches, low energy.  Parent took patient to ER for further evaluation.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient was given MMRV instead of MMR. PT also received dose of Varicella on date of service.
Age: 82.0
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC reported; Nurse called and reported that a dose of PROQUAD was inadvertently administered to an adult patient no 4/16/2025. Caller stated no patient symptoms have been reported. No additional AE/no PQC reported.; This spontaneous report was received from a nurse and refers to an 82-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 16-APR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (valid lot number Y009108, expiration date: 06-NOV-2025) one dose with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported) prophylaxis (product administered to patient of inappropriate age).  No adverse event (AE) reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure 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: 27-APR-2025 This case was reported by patient's child via interactive digital media. Reporter's parent had gotten it after they had received the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR051995, reported by same reporter.; 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. US-GSK-US2025AMR051995:female case
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Autoimmune disorder, Blood pressure increased, Dysarthria, Dysstasia, Immunoglobulin therapy
Clinical narrative: Patient's representative called to notify me of ongoing issues post RSV vaccination.  Issues include thyroid dysfunction caused by an autoimmune response, trouble standing, increased blood pressures and slurred speech.  Patient diagnosised with myasthenia gravis and given immunoglobulin therapy which helped relieve symptoms.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Myasthenia gravis, Thyroid disorder
Clinical narrative: Patient's representative called to notify me of ongoing issues post RSV vaccination.  Issues include thyroid dysfunction caused by an autoimmune response, trouble standing, increased blood pressures and slurred speech.  Patient diagnosised with myasthenia gravis and given immunoglobulin therapy which helped relieve symptoms.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Asthenia, Back disorder, Balance disorder, Condition aggravated, Dyspnoea
Clinical narrative: Patient's representative called to notify me of ongoing issues post RSV vaccination.  Issues include thyroid dysfunction caused by an autoimmune response, trouble standing, increased blood pressures and slurred speech.  Patient diagnosised with myasthenia gravis and given immunoglobulin therapy which helped relieve symptoms.
Age: 75.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Fatigue, Mechanical ventilation, Muscular weakness, Weight decreased
Clinical narrative: Patient's representative called to notify me of ongoing issues post RSV vaccination.  Issues include thyroid dysfunction caused by an autoimmune response, trouble standing, increased blood pressures and slurred speech.  Patient diagnosised with myasthenia gravis and given immunoglobulin therapy which helped relieve symptoms.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: technician administered vaccine IM instead of SC. per manufacturer ref number 02289659 marco, no increased risk of adverse events and no need to repeat vaccine.
Age: 23.0
Sex: M
Vaccine: IPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: I was supposed to be receiving a Tuberculin PPD test intradermally in the left arm and instead received IPOL (inactivated poliovirus). The first day the spot location began to swell and the next day I noticed a head cold- fever, fatigue/malaise along with substantial amount of green mucous coming out of my nose and throat. The area where I was injected also started lightly throbbing over the next couple of days along with a red dot near the site of infection that became more faint over the next few days.
Age: 23.0
Sex: M
Vaccine: IPV
Symptoms: Mucosal discolouration, Nasopharyngitis, Pyrexia
Clinical narrative: I was supposed to be receiving a Tuberculin PPD test intradermally in the left arm and instead received IPOL (inactivated poliovirus). The first day the spot location began to swell and the next day I noticed a head cold- fever, fatigue/malaise along with substantial amount of green mucous coming out of my nose and throat. The area where I was injected also started lightly throbbing over the next couple of days along with a red dot near the site of infection that became more faint over the next few days.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Administered peds hep B dose to adult patient
Age: 36.0
Sex: M
Vaccine: IPV
Symptoms: Cold sweat, Dizziness
Clinical narrative: Patient became very dizzy and light headed after receiving vaccine. Broke out in a cold sweat.  Patient blood pressure was normal with first reading. Second reading would not register.  Patient's spouse, a nurse, stated patient had come straight from giving plasma and had not eaten.  Patient refused to speak with store management and refused offer for emt's.  Patient was given some candy to help with possible low blood sugar from giving plasma and water also due to giving plasma.  After about 15 to 20 minutes patient stated dizziness had subsided and blood pressure readings were back to normal again. Patient stated felt better and wanted to leave without any other intervention. Spouse took patient home. patient returned to store later in evening around 6:20 pm to advise he was feeling better after eating
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No actual sign of adverse event reported, however pt administered vaccine 5 months apart (not per guidelines).  Pharmacy requires adverse reporting to VAERS since administered outside of guidelines.
Age: 69.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: Patient complains of knott in arm / swelling at injection site and red dotting. Patient also complains of pain in the arm
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Within six weeks of the vaccination I developed scalp psoriasis. I never had it before.
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a men B vaccine without any indicated risk factors to support administration before 16 years of age
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Blood test, Electromyogram, Fall
Clinical narrative: -Moderna (1.29.2021)previously reported...series of external inflammatory reactions throughout body...for 4-6 weeks. Given at pharmacy. ---Pfizer (11.20.21)  by the listed pharmacy---was given an overdose by nurse.  Had internal areas of pain for 3/1/2 years not realizing that all of these years I was suffering because of the vaccine!  Both legs are much weaker (have trouble walking when first get up); I fell twice last year. have trouble with stairs now, elbow is very painful (trouble picking  up things); shoulder hurts and now my lower back.  Call me for more details...I tried to list it all here, but I was timed out....very frustrating!!!
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Incorrect dose administered, Inflammation, Magnetic resonance imaging, Muscular weakness
Clinical narrative: -Moderna (1.29.2021)previously reported...series of external inflammatory reactions throughout body...for 4-6 weeks. Given at pharmacy. ---Pfizer (11.20.21)  by the listed pharmacy---was given an overdose by nurse.  Had internal areas of pain for 3/1/2 years not realizing that all of these years I was suffering because of the vaccine!  Both legs are much weaker (have trouble walking when first get up); I fell twice last year. have trouble with stairs now, elbow is very painful (trouble picking  up things); shoulder hurts and now my lower back.  Call me for more details...I tried to list it all here, but I was timed out....very frustrating!!!
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Post vaccination syndrome
Clinical narrative: -Moderna (1.29.2021)previously reported...series of external inflammatory reactions throughout body...for 4-6 weeks. Given at pharmacy. ---Pfizer (11.20.21)  by the listed pharmacy---was given an overdose by nurse.  Had internal areas of pain for 3/1/2 years not realizing that all of these years I was suffering because of the vaccine!  Both legs are much weaker (have trouble walking when first get up); I fell twice last year. have trouble with stairs now, elbow is very painful (trouble picking  up things); shoulder hurts and now my lower back.  Call me for more details...I tried to list it all here, but I was timed out....very frustrating!!!
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: patient was administered ROTATEQ & VAXELIS during a temperature excursion.; No additional AE reported.; This spontaneous report was received from an office manager concerning to a patient of unknown age and gender.   The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 24-Apr-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), Oral solution (lot #2088619, expiration date: 09-Mar-2026) 1 dosage form (1 dose), administered by Oral route and with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS), Suspension for injection (lot #U7947AA, expiration date: 20-Oct-2026) 1 dosage form (1 dose; strength 0.5 mL) (route of administration not reported), both as Prophylaxis. However, the reporter stated that these doses underwent a temperature excursion at 0°C for 1 hour, no previous excursions had occurred, no additional events or details reported.; Reporter's Comments:
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; Nurse called to report that an expired dose of PROQUAD was administered to 1 patient. Caller stated the product expired 3/20/2025 and was administered 4/30/2025. Caller stated product was never involved in a temperature excursion. Caller stated no pa; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 30-APR-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot #X023401, expiration date: 20-Mar-2025 (expired product administered) (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (no details provided).  It was reported that product was never involved in a temperature excursion.  No adverse events reported.
Age: 14.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL, VARCEL, VARCEL, VARCEL, VARCEL
Symptoms: Autoimmune disorder, COVID-19, Extra dose administered, Pyrexia
Clinical narrative: Might have autoimmune disease; A HCP called to inquire how soon a patient (who is simultaneously being worked up for an unknown autoimmune disease) could or would develop a fever after receiving an injection of VARIVAX.  The HCP stated a patient was administered a dose of VARIVAX; the dose of VARIVAX should not have been administered on 04/30/2025, because the patient had  already received two prior doses of VARIVAX on 09/18/2005 and 04/06/2009; COVID; This spontaneous report was received from a physician and refers to a 34-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-SEP-2005, the patient was vaccinated with first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (dose, lot number and expiration date were not reported), 06-APR-2009, with the second dose (dose, lot number and expiration date were not reported) and on 30-APR-2025, with the third dose (valid lot number Y013346, expiration date: 02-AUG-2026) 0.5 mL, once, subcutaneously, all of them with sterile diluent (BAXTER STERILE DILUENT) (dose, lot number and expiration date were not reported) for vaccination due to an exposure to chickenpox approximately 7-8 days ago, but had two prior vaccinations in the past and the HCP who administered misread the chart and gave a third vaccine (prophylaxis).  On an unknown date, the patient was worked up for an unknown autoimmune disease), on 30-APR-2025, she developed a fever (pyrexia) of 101.5 degrees Fahrenheit about 2 hours after the vaccine, on a unknown date in April 2025 (reporter as about one month ago) the patient had COVID, so she did not think the fever was related to COVID and the facility was going to also test the patient for the flu. The person who administered the vaccine read the patient's medical record incorrectly and the dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) should not have been administered on 30-APR-2025, because the patient had already received two prior doses of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) on 18-SEP-2005 and 06-APR-2009 (extra dose administered). The patient did not report any other adverse issues or side effects from the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) administered on 30-APR-2025 and the healthcare provider (HCP) was not aware of the patient having experienced any adverse issues or side effects from the prior doses either. At the reporting time, the outcome of the events was not provided.   The causal relationship between the events Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and sterile diluent (BAXTER STERILE DILUENT) was not provided.   Upon internal review, the event autoimmune disease was determined to be medically significant.
Age: 14.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL, VARCEL, VARCEL, VARCEL, VARCEL
Symptoms: Body temperature increased, Exposure to communicable disease, Extra dose administered
Clinical narrative: Might have autoimmune disease; A HCP called to inquire how soon a patient (who is simultaneously being worked up for an unknown autoimmune disease) could or would develop a fever after receiving an injection of VARIVAX.  The HCP stated a patient was administered a dose of VARIVAX; the dose of VARIVAX should not have been administered on 04/30/2025, because the patient had  already received two prior doses of VARIVAX on 09/18/2005 and 04/06/2009; COVID; This spontaneous report was received from a physician and refers to a 34-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-SEP-2005, the patient was vaccinated with first dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (dose, lot number and expiration date were not reported), 06-APR-2009, with the second dose (dose, lot number and expiration date were not reported) and on 30-APR-2025, with the third dose (valid lot number Y013346, expiration date: 02-AUG-2026) 0.5 mL, once, subcutaneously, all of them with sterile diluent (BAXTER STERILE DILUENT) (dose, lot number and expiration date were not reported) for vaccination due to an exposure to chickenpox approximately 7-8 days ago, but had two prior vaccinations in the past and the HCP who administered misread the chart and gave a third vaccine (prophylaxis).  On an unknown date, the patient was worked up for an unknown autoimmune disease), on 30-APR-2025, she developed a fever (pyrexia) of 101.5 degrees Fahrenheit about 2 hours after the vaccine, on a unknown date in April 2025 (reporter as about one month ago) the patient had COVID, so she did not think the fever was related to COVID and the facility was going to also test the patient for the flu. The person who administered the vaccine read the patient's medical record incorrectly and the dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) should not have been administered on 30-APR-2025, because the patient had already received two prior doses of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) on 18-SEP-2005 and 06-APR-2009 (extra dose administered). The patient did not report any other adverse issues or side effects from the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) administered on 30-APR-2025 and the healthcare provider (HCP) was not aware of the patient having experienced any adverse issues or side effects from the prior doses either. At the reporting time, the outcome of the events was not provided.   The causal relationship between the events Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and sterile diluent (BAXTER STERILE DILUENT) was not provided.   Upon internal review, the event autoimmune disease was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix adjuvant only administered; Shingrix adjuvant only administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number MG5S9, expiry date 30-MAR-2027) for prophylaxis.   On 18-APR-2025, the patient received Shingrix. On 18-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 28-APR-2025 The clinical manager called today to report that the adjuvant portion of the Shingrix vaccine was administered to a patient on April 18, 2025 which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 21.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Cold sweat, Lip discolouration, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Within 5 minutes after vaccines, patient had syncope event with pale, clammy skin and gray lips.  She was still breathing but unresponsive for about 3 minutes.  It took about 45 minutes for recovery with monitoring by local EMS.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen and hot spreading down arm.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Feeling abnormal, Hyperhidrosis, Loss of consciousness, Tremor
Clinical narrative: Patient 20 years old got a Boostrix vaccine (Tdap) on left arm (intramuscular) today 5/3/25 around 10:10 am and a few minutes after the vaccine she lost conscious and started having slight tremors that lasted a few seconds. After her tremors she said she felt like sweating and felt    " weird" . She had to sit down for a few more minutes until a friend came to pick her up
Age: 5.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Oxygen saturation decreased, Unresponsive to stimuli, Vomiting
Clinical narrative: Vomiting, unresponsive, low oxygen saturation
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Patient was previously vaccinated with Arexvy October 06, 2023.  Patient is not experiencing any adverse events at this time, other than typical mild arm soreness at the injection site.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: PER PT WIFE WAS UNABLE TO WALK FOR A COUPLE OF DAYS
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: PER PATIENT WAS BARLEY ABLE TO WALK FOR A COUPLE OF DAYS
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Spoke to patient about getting second dose of vaccine (Boostrix) since initial was given 2/5/25. Patient only reported having sore arm.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Axillary pain, Injection site discolouration, Peripheral swelling, Thrombotic thrombocytopenic purpura
Clinical narrative: Arm swelling and pain under axilla and extending to elbow. TTP.  Pink patches distal to injection site.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Raised hard red lump at site of injection (right arm), about the size of half a deck of cards, warm to the touch, within 24 hours of getting the vaccine.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: patient had pain in left deltoid later the same day after injection that persisted for at least 4 weeks.  pain 8/10 and was unable to lift his arm.  first seen by PCP on 5/2/25 (about 4 weeks after injection).   pain is improving but still 2/10.  he declined imaging of area. no evidence of infection or DVT.  suspect intramuscular hematoma vs localized reaction to vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient had normal reaction on day 1, mild redness/warmth/swelling. By day 2, swelling border had increased , and by day 3 (Monday), border was between 2-3 inches. Patient went to the prescriber office and they decided to treat for possible cellulitis vs strong reaction to vaccine. Patient had possible reaction to doxycycline (mild rash) so was changed to cephalexin on 4/30/25.  Had noticed slight improvement on doxycycline
Age: 64.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Patient said that she had a very sore arm on her left side (side shingrix was given) and developed a rash on her upper body, her left arm and left arm pit. She noticed the rash on 4/21/25 and went to urgent care.  At urgent care, she was prescribed prednisone.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: Patient called reporting "flu like symptoms", redness at the injection site, and warmth at the injection site.  Patient reports taking TYLENOL to help with these symptoms, and she does feel better now (5/2/25)
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This error involves a 3rd dose of Twinrix that was administered 4 months early. First dose: 11/2/24 2nd dose: 12/7/24 3rd dose: 1/13/25 instead of May (This VAERS report)
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient had a widespread rash develop over his legs that was very itchy within a week of getting the vaccine.  He said that it mostly improved over the course of 2-3 weeks but has one itchy section by his ankle that his never improved until this day.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Acne, Furuncle, Pruritus
Clinical narrative: PATIENT SAID HIS RIGHT ARM ITCHES AND NOW HE HAS A PIMPLE/BOIL WHITE WHITE PUS THE SIZE OF  A BLACK PEPPER.  RECOMMENDED HIM TO GO TO A DOCTOR AND GET ANTIBIOTIC JUST IN CASE.  HE SAID HE DOES NOT WANT TO.  TOLD HIM TO USE NEOSPORIN JUST IN CASE.  HE SAID HE WILL GO TO THE DOCTOR IF IT GETS WORSE.  REPEATED TO HIM THAT HE SHOULD GO AS SOON AS POSSIBLE IF HE'S CONCERN.  REPORTING AS SOON AS HE INFORM US TODAY.
Age: 61.0
Sex: M
Vaccine: PNC21, RSV, TDAP, VARZOS
Symptoms: Erythema, Pain, Pharyngeal swelling, Swelling face
Clinical narrative: Patient received 4 vaccines and next day came to pharmacy complaining about throat swelling, redness on the administered arm and pain. His face was swollen and had redness on the right arm. Reecommended to urgent care to further treatment if needed. Patient did receive 3 more vaccines and those were give on left arm
Age: 40.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site hypoaesthesia
Clinical narrative: Shortly after receiving the vaccine, I experienced unusual and significant bleeding at the injection site. Within 24 hours, a large, dark bruise developed. On March 23, I began experiencing numbness in my vaccinated arm, which continued for 5 days. I have never experienced such symptoms with any prior vaccination.  What concerns me even more is that I later discovered, through the documentation I received, that the vaccine was administered by an intern. At no point was I informed or asked for consent to be treated by an intern. Furthermore, there was no supervising pharmacist or licensed medical professional visibly present during the injection. This means the intern performed the vaccination without my informed consent and without direct supervision, a clear violation of  Codes R. & Regs. where it specifies "A certified pharmacy intern may only administer immunizations under the immediate personal supervision of the certified pharmacist" and section (a)(5)(v) where it specifies that "a certified pharmacist shall not allow a certified pharmacy intern to administer immunizations unless the recipient is informed that the pharmacy intern will be administering the immunization and the recipient consents to administration of the immunization by the certified pharmacy intern"
Age: 40.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Shortly after receiving the vaccine, I experienced unusual and significant bleeding at the injection site. Within 24 hours, a large, dark bruise developed. On March 23, I began experiencing numbness in my vaccinated arm, which continued for 5 days. I have never experienced such symptoms with any prior vaccination.  What concerns me even more is that I later discovered, through the documentation I received, that the vaccine was administered by an intern. At no point was I informed or asked for consent to be treated by an intern. Furthermore, there was no supervising pharmacist or licensed medical professional visibly present during the injection. This means the intern performed the vaccination without my informed consent and without direct supervision, a clear violation of  Codes R. & Regs. where it specifies "A certified pharmacy intern may only administer immunizations under the immediate personal supervision of the certified pharmacist" and section (a)(5)(v) where it specifies that "a certified pharmacist shall not allow a certified pharmacy intern to administer immunizations unless the recipient is informed that the pharmacy intern will be administering the immunization and the recipient consents to administration of the immunization by the certified pharmacy intern"
Age: 40.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Hypoaesthesia, Injection site bruising, Injection site haemorrhage, Injection site hypoaesthesia
Clinical narrative: Shortly after receiving the vaccine, I experienced unusual and significant bleeding at the injection site. Within 24 hours, a large, dark bruise developed. On March 23, I began experiencing numbness in my vaccinated arm, which continued for 5 days. I have never experienced such symptoms with any prior vaccination.  What concerns me even more is that I later discovered, through the documentation I received, that the vaccine was administered by an intern. At no point was I informed or asked for consent to be treated by an intern. Furthermore, there was no supervising pharmacist or licensed medical professional visibly present during the injection. This means the intern performed the vaccination without my informed consent and without direct supervision, a clear violation of  Codes R. & Regs. where it specifies "A certified pharmacy intern may only administer immunizations under the immediate personal supervision of the certified pharmacist" and section (a)(5)(v) where it specifies that "a certified pharmacist shall not allow a certified pharmacy intern to administer immunizations unless the recipient is informed that the pharmacy intern will be administering the immunization and the recipient consents to administration of the immunization by the certified pharmacy intern"