chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Myalgia, Pain, Swelling
Clinical narrative: Started having swelling, pain, muscular pain when pulling up pants, started once she got home.  Mom also endorsed redness as well at the site.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Comirnaty vaccine on 6/14/2025 and noticed injection site redness starting the next day. On 6/17/25 the patient returned to the pharmacy to show the reaction. The injection site was red, swollen, and warm to the touch. The patient was seen at her PCP office on 6/17/25 for suspected cellulitis.  The prescriber advised the patient to watch the injection site for another 1-2 days and take an antibiotic only if the reaction worsens or does not improve.
Age: 84.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Malaise
Clinical narrative: full body malaise - pt did /does not have enough time to discuss further
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: THIRD DOSE OF SHINGLES VACCINE
Sex: F
Vaccine: PNC21
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: FBE calling to report AE for CAPVAXIVE on behalf HCP who is also the patient. Patient reports experiencing injection site pain immediately after receiving CAPVAXIVE. Patient reports the pain did not subside for a couple of days and still feels linger; This spontaneous report was received from a Consumer and refers to a Elderly female patient over 65 years of age. The patient's concurrent conditions/medical history included arthritis rheumatoid. Concomitant therapies, drug reactions or allergies were not provided.    On an unspecified date in April 2025 (reported as "sometime in April"), the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), administered Intramuscularly (strength, lot #, expiration date, dose number, anatomical location not provided) as vaccination.   The patient reported that immediately after receiving the vaccine, she experienced injection site pain, and the pain did not subside for a couple of days. On an unspecified date in 2025, the patient recovered from the event, but she stated that still felt lingering pain to this day.   The causal relationship between vaccination site pain and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP called to report T/E for VARIVAX on dates 5/30/2025 and 6/10/202. VARIVAX was administered on 6/11/2025.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported.  On 11-Jun-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) (VARIVAX) injection, administered as prophylaxis (Lot No. Z003882 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 03-Feb-2027)(strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (MERCK STERILE DILUENT) (indication, Lot No., and expiration date were not provided); after a temperature excursion of 8.0 degree Fahrenheit (F) during a time frame of 15 minutes that occurred (on 30-May-2025 and 10-Jun-2025) (reported as 10-Jun-202, conflicting information). Previous temperature excursion reported of 9.0 degree Fahrenheit (F) during a time frame of 15 minutes. No additional information or adverse events or PQC were provided (no adverse event).
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP called to report T/E for VARIVAX on dates 5/30/2025 and 6/10/2025. VARIVAX was administered on 6/09/2025.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported.  On 09-Jun-2025, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka-merck) (VARIVAX) injection, administered as prophylaxis (Lot No. Z003882 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 03-Feb-2027)(strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (MERCK STERILE DILUENT) (indication, Lot No., and expiration date were not provided); after a temperature excursion of 8.0 degree Fahrenheit (F) during a time frame of 15 minutes that occurred (on 30-May-2025 and 10-Jun-2025). Previous temperature excursion reported of 9.0 degree Fahrenheit (F) during a time frame of 15 minutes. No additional information or adverse events or PQC were provided (no adverse event).
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion on punctured mdv of ipol temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered with a vaccine that had temperature excursion on punctured MDV of IPV (VERO) [IPOL] temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (lot number, strength and expiry date-unknown) for prophylactic vaccination (Immunisation) was exposed to temperature of 8.5 degrees Celsius and were out of range for a total of 14 minutes with no reported adverse event (product storage error).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly- Human error was involved (refrigerator being unplugged by mistake). Previous excursion on 24-apr-2025 max of 8.44 degrees Celsius for 13 minutes, due to the refrigerator door being left open.  Action taken was not applicable.  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.  Additional information was received on 13-Jun-2025 from other healthcare professional: case was updated to valid from non-valid; text amended accordingly.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pre-assessed as a medication error/an inappropriate use due to prescription of inappropriate vaccine and receiving unindicated extra dose of MENQUADFI with no reported adverse event; Initial information received on 13-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 year old female patient who received unindicated extra dose of Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Mar-2019, the patient received an unknown dose (dose 1) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection and On 12-Jul-2024 she also received an unknown dose (dose 2) of vaccine both with (lot number and expiry date-unknown) via unknown route in unknown administration site. On 13-Jun-2025 she received an extra dosed 0.5ml (dose 3) standard strength of vaccine (lot-U8194AA) (expiry date-unknown) via intramuscular route in left deltoid for Immunization with no reported adverse event (extra dose administered).  Reportedly- Nurse stated that the patient should have received MenB (Bexsero) but the provider mistakenly ordered Menquadfi instead.  Action taken was not applicable.   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: 44.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave the patient their 3rd dose sooner than 6 months from 1st but was given at least 8 weeks from 2nd dose
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired displayed no symptoms.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: None at time of initial check in with pt.  Pt is to return and get ordered vaccine as provider states the vaccine that was administered on 6/17 is a booster and can be followed up with the originally ordered vaccine.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was supposed to receive Hep B Vaccine but received Hep A vaccine instead. No adverse reactions were noted by the pt or healthcare provider.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Laboratory test normal, Postictal state
Clinical narrative: On 8/17/2022, I had a tonic clonic seizure around 6am. I was sleeping in bed, and the event woke my husband up. I do not remember the immediate moments thereafter as I was postictal. I was taken via ambulance to the nearest hospital where I stayed overnight. I had numerous tests including lab work, CT scan, and EEG. After discharge I then had a sleep-deprived EEG and had to see a neurologist. I was started on an increasing taper dose of Lamictal that I still take BID. I continue to follow up with the Neurologist yearly. The cause of the seizure has never been determined.
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20, RV1
Symptoms: No adverse event
Clinical narrative: No adverse events/treatment or outcome
Age: 0.33
Sex: F
Vaccine: HEP, HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: third dose was given as an early dose; 2nd dose administered on 16 Jan 2015; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Concomitant products included Hepatitis b vaccine.   On 06-MAR-2015, the patient received the 3rd dose of Engerix B. On 16-JAN-2015, the patient received the 2nd dose of Hepatitis B vaccine. On 16-JAN-2015, not applicable after receiving Engerix B and an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose administered on 16 Jan 2015). On 06-MAR-2015, the patient experienced drug dose administration interval too short (Verbatim: third dose was given as an early dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JUN-2025 Physician explained that a 10 year old patient received by accident an expired forth dose of a Hepatitis B vaccine (lot number W025817, expiration date 21st May 2025, brand name not provided by the caller, but they mentioned that it was non-GSK product) on 2nd June 2025 since they noticed that their third dose was given as an early dose. First dose of Hepatitis B was given on 5th November 2014, second dose on 16th January 2015 and third dose on 6th March 2015 which led to Drug dose administration interval too short. Physician did not know what the brand name or lot number for any of the 3 prior doses was. Adverse Event report sent as a preventive measure as a potential early third dose of Engerix-B, and potential interchangeability, since the fourth dose was not a GlaxoSmithKline vaccine. Caller decided to end the call when they noticed that the fourth dose was not from GlaxoSmithKline so Medical Information did not have time to ask for consent to follow up with Safety Team. The patient received 2nd dose of Hepatitis B later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, MMR, PNC20, VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccine Influenza Flulaval 0.5 ML was given with expiration date 6/11/25 on 6/12/25 at 4:00pm.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Limb injury
Clinical narrative: Shoulder injury. Injection into rotator cuff.   Sling, ice, rest, antiinflammatory.  Possible MRI and orthopedic referral.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event was reported; A HCP transferred from a MVCC CRT agent called to inquire about GARDASIL 9 and whether or not the series should be restarted for a 45-year-old patient who received an initial dose sometime in 2021 and a second dose yesterday, 06/08/2025. The HCP stat; This spontaneous report was received from a pharmacist and refers to a 45-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 2021, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), dose number 1, (indication, expiration date, and lot # were not reported). On 08-Jun-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (lot #Y020531, expiration date: 05-Aug-2027), dose number 2, 0.5 mL for an unknown indication (Inappropriate schedule of vaccine administered). No additional adverse event was reported.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arteriogram carotid, Computerised tomogram head normal, Deafness neurosensory, Scan with contrast normal, Sudden hearing loss
Clinical narrative: Sudden Sensorineural Hearing Loss occurring on 12/21/2024
Age: 11.0
Sex: M
Vaccine: MNQ, UNK
Symptoms: Fatigue, Loss of consciousness, Pallor, Thirst, Vomiting
Clinical narrative: 06/17/2025 1600  was given TD and meningitis vaccines.1605 he started walking around in circles then he said he was tired then he started screaming for water I open door to get help ask for water he turns pale as a ghost and passes out in chair. I get him up grab some cold water from sink on paper towel to put around his neck and dab is face. They bring in water Dr comes in shoves a lollipop in his mouth he spits it out says I'm going to throw up. I grab a trashcan he vomits. They bring in gingerale he drinks it says still feels tired. I ask if they have any snacks or something else they bring some peanuts. His color starts coming back and his eyes look better. He said I felt like I died. Vitals were checked after 15 minutes of color return and we were able to leave.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient given Bexsero.  Patient should have received Menveo.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Passed away
Age: 1.67
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Immunization was given and noticed to be expired after given. No reactions to vaccine.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: none
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event happened to patient. We are documenting the incorrect vaccine given at the visit.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Chest pain, Dysarthria, Dyspnoea, Fatigue, Hemiparesis
Clinical narrative: Pt was well while at the HD. However, upon returning home pt's son reported that patient's speech was slurred and she was tired and went done for a nap. Upon waking at 1:30pm pt was weak and pts right side was more weak than the left. Pt complained of chest paind and shortness of breath. EMS was called and pt was taken to hospital and was later transferred to a second hospital.
Age: 37.0
Sex: M
Vaccine: YF
Symptoms: Dermatitis allergic, Gastrointestinal disorder, Rash
Clinical narrative: Gastrointestinal issues and allergic rashes on hands. Doctors have no idea what to do for it so there have been no treatments and the adverse events are ongoing.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Facial pain, Fatigue, Malaise, Pain
Clinical narrative: patient received immunization on 6/17/25 at approximately 4:48pm.  the patient presented to the pharmacy today (6/18/25) at approximately 9am and said that she has been experiencing throbbing on the right side of the face since the immunization yesterday.  she said the throbbing lasts for up to a minute, then stops for a few minutes, and then starts again.  she said the frequency has been constant since her immunization yesterday.  the only other symptoms she is experiencing is fatigue and general malaise per patient.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional adverse event was reported; HCP called to report an AE for PROQUAD.  Caller reported that an 18 month old female patient was inadvertently administered PROQUAD and VARIVAX concomitantly today, 6/9/2025.  Caller reported that patient was behind on here 12 and 15 month vaccines a; stated that they believed it was MMRII because the vials are similar.; This spontaneous report was received from a nurse and refers to a 18-month-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 09-Jun-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z005153, expiration date: 25-Aug-2026) 0.5 mL for an unknown indication. On 09-Jun-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #Y020586, expiration date: 17-Dec-2026) 0.5 mL for an unknown indication. On 09-Jun-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). On 09-Jun-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). It was reported that the patient was inadvertently administered Proquad and Varivax xonxomitantly (Accidental overdose). Caller reported that patient was behind on here 12 and 15 month vaccines and stated that they believed it was MMRII because the vials are similar (Look alike packaging). No additional adverse event was reported.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Dermatomyositis, Muscular weakness, Rash
Clinical narrative: Sudden onset of MDA5 Dermatomyositis. Skin rash, muscle weakness, joint pain.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives on the armpit, behind both legs, and now behind right ear
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Pt present to clinic asking for a Hepatitis B vaccine due to blood work not showing immunity, Pt states that she does not have any allergies or any side effects in the past to any vaccines, Prior to administering the vaccine Pt asked if the vaccine was an adult dosage and I did informed the patient that it was an adult dosage, I did gave a Pt a copy of the vaccine record indicating that it was an adult dosage and Pt left
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Type III immune complex mediated reaction
Clinical narrative: Child with Arthus Reaction: Erythematous and indurated area on left thigh
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Discomfort
Clinical narrative: Symptoms started around 9:30am on 6/16/2025. Started as slight shaky and weak feeling throughout the body, progressed to full body aches and fever with chills as well, as if body could not decide if it was hot or cold. By 11:00am symptoms were in full effect and I experienced labored breathing with fever reaching 100 degrees Fahrenheit. Before noon, joint pain in knees, arms, legs, back, and feet started, putting me in more pain and discomfort. I was struggling to focus on work and had trouble writing and typing on computer due to extreme weakness. Headaches made it difficult to concentrate on work and leg pain made it difficult to sit in chair for too long. Symptoms lessened by evening, was still experiencing leg pain and whole body aches with headaches. Took Aleve to help lessen aches, leg pain worsened during the night when I would lay down to sleep. Pain became unbearable during this time, making sleep impossible. It has now been over 48 hours since symptoms started on 6/16 and only slight leg and knee pains persist today, 6/18. Fever and chills are gone as well as whole body weakness and aches.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Feeling of body temperature change, Headache, Impaired work ability, Influenza virus test negative
Clinical narrative: Symptoms started around 9:30am on 6/16/2025. Started as slight shaky and weak feeling throughout the body, progressed to full body aches and fever with chills as well, as if body could not decide if it was hot or cold. By 11:00am symptoms were in full effect and I experienced labored breathing with fever reaching 100 degrees Fahrenheit. Before noon, joint pain in knees, arms, legs, back, and feet started, putting me in more pain and discomfort. I was struggling to focus on work and had trouble writing and typing on computer due to extreme weakness. Headaches made it difficult to concentrate on work and leg pain made it difficult to sit in chair for too long. Symptoms lessened by evening, was still experiencing leg pain and whole body aches with headaches. Took Aleve to help lessen aches, leg pain worsened during the night when I would lay down to sleep. Pain became unbearable during this time, making sleep impossible. It has now been over 48 hours since symptoms started on 6/16 and only slight leg and knee pains persist today, 6/18. Fever and chills are gone as well as whole body weakness and aches.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: Symptoms started around 9:30am on 6/16/2025. Started as slight shaky and weak feeling throughout the body, progressed to full body aches and fever with chills as well, as if body could not decide if it was hot or cold. By 11:00am symptoms were in full effect and I experienced labored breathing with fever reaching 100 degrees Fahrenheit. Before noon, joint pain in knees, arms, legs, back, and feet started, putting me in more pain and discomfort. I was struggling to focus on work and had trouble writing and typing on computer due to extreme weakness. Headaches made it difficult to concentrate on work and leg pain made it difficult to sit in chair for too long. Symptoms lessened by evening, was still experiencing leg pain and whole body aches with headaches. Took Aleve to help lessen aches, leg pain worsened during the night when I would lay down to sleep. Pain became unbearable during this time, making sleep impossible. It has now been over 48 hours since symptoms started on 6/16 and only slight leg and knee pains persist today, 6/18. Fever and chills are gone as well as whole body weakness and aches.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Tremor
Clinical narrative: Symptoms started around 9:30am on 6/16/2025. Started as slight shaky and weak feeling throughout the body, progressed to full body aches and fever with chills as well, as if body could not decide if it was hot or cold. By 11:00am symptoms were in full effect and I experienced labored breathing with fever reaching 100 degrees Fahrenheit. Before noon, joint pain in knees, arms, legs, back, and feet started, putting me in more pain and discomfort. I was struggling to focus on work and had trouble writing and typing on computer due to extreme weakness. Headaches made it difficult to concentrate on work and leg pain made it difficult to sit in chair for too long. Symptoms lessened by evening, was still experiencing leg pain and whole body aches with headaches. Took Aleve to help lessen aches, leg pain worsened during the night when I would lay down to sleep. Pain became unbearable during this time, making sleep impossible. It has now been over 48 hours since symptoms started on 6/16 and only slight leg and knee pains persist today, 6/18. Fever and chills are gone as well as whole body weakness and aches.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: PT RECEIVED THE TDAP VACCINE AND LATER DEVELOPED SWELLING/ITCHING, REDNESS, AND PAIN THAT GREW OVER NIGHT INTO THE NEXT MORNING. PARENTS/GUARDIANS DID NOT GIVE HER ANY ANTI-HISTAMINE OR TREATMENT.
Age: 52.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warmth, redness around injection sites given in left arm. Both were given in left arm; redness spread away from injection site and urgent care MD treating as potential skin infection as precaution.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: PT REPORTED SWELLING, REDNESS, PAIN, WARM TO TOUCH 12-24 HOURS AFTER VACCINATION
Age: 18.0
Sex: F
Vaccine: HEP, MENB
Symptoms: Arthralgia, Injected limb mobility decreased, Joint swelling, Muscular weakness, Musculoskeletal pain
Clinical narrative: Right deltoid shoulder pain, decreased ROM, shooting pain in right shoulder blade with movement, right arm weakness, right arm achiness, intermittent tingling down right arm and hand. Swelling of right shoulder and shoulder blade. Tenderness to palpation. Treatment originally included NSAIDs, ice, warmth, and gentle stretching without improvement. Patient returning to care for revaluation on 06/19/2025.
Age: 18.0
Sex: F
Vaccine: HEP, MENB
Symptoms: Pain, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Right deltoid shoulder pain, decreased ROM, shooting pain in right shoulder blade with movement, right arm weakness, right arm achiness, intermittent tingling down right arm and hand. Swelling of right shoulder and shoulder blade. Tenderness to palpation. Treatment originally included NSAIDs, ice, warmth, and gentle stretching without improvement. Patient returning to care for revaluation on 06/19/2025.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine given. The patient should have received Menveo not Bexsero. The patient was 11 years of age at the time of the vaccine administration. Per Health Department age range for Bexsero is 16-23
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Pruritus, Urticaria
Clinical narrative: diffuse urticarial rash, resolved with benadryl with residual itching
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Brain fog, Decreased appetite
Clinical narrative: PATIENT REPORTED ONSET OF BRAIN FOGGINESS, LOSS OF APPETITE, LOSS OF ENERGY TO DO ANYTHING SINCE RECEIVING HIS MODERNA VACCINE ON 06/13/2025. ACCORDING TO HIM SYMPTOMS STARTED SOON AFTER THE VACCINE.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Loss of consciousness, Nausea, Somnolence
Clinical narrative: Patient was administered 2 vaccines. Approximately 5 minutes later patient reported nausea and dizziness. Patient passed out on the exam table a couple of minutes later. The provider was asked to come to the room for examination. Patient came to shortly thereafter. She reported feeling groggy. Patient was kept in office for 45 minutes and vitals were monitored.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain, Pain in extremity, Urticaria, Yellow skin
Clinical narrative: Pt's L arm started to get a hive type reaction on day one after vaccination : red large welt that grew to cover her whole upper L arm x 5 days. Pt reports that her arm was painful to lift up.  It stayed red and welted even after taking Benadryl a few times and then just started to turn yellow and go away. Was completely resolved after day 5.
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B virus test positive
Clinical narrative: Patient received vaccine on 06/03/2025 and was tested for Hep B at blood donor center and he was tested positive.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no signs or symptoms
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: We offer Heb to our employees and on her first day she consented to get the Hep B, I gave it to her the same day, Today she showed me her arm and it is swollen and itchy, no fever or anything. No treatment sought.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse.   I gave patient Tdap that expired on 6/13/25 on 6/18/25.  We did document into database.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Medical assistant grabbed vaccine from unit and prepped vaccine administered vaccine in left deltoid of patients arm and when MA was documenting this was when they then realized this was expired, MA went to manager of site and Vaccine coordinator of company and also called CDC.
Age: 11.0
Sex: M
Vaccine: HIBV, HPV9, TDAP
Symptoms: Wrong product administered
Clinical narrative: Gave Patient HIB instead of Meningococcal Conjug
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had redness, swelling, pain at the injection site. patient is being treated with antibiotics from her physician, in case it is an infection from the vaccine.  vaccine was given on 5/22/2025 and started receiving antibiotics on 6/12/25 from her physician and is starting a second round of antibiotics on 6/18/25 to make sure the infection is gone.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Erythema, Tenderness
Clinical narrative: Donor developed a 3"x4" Reddened area that was tender to the touch several hours after receiving the vaccine
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Body temperature increased, Chest X-ray, Pain in extremity
Clinical narrative: He had his pneumococcal 23 vaccine Thursday, June 12.  He had the vaccine in his left arm.  He woke up the following day complaining of left arm pain, though mom thought this was just because of his recent vaccine.  The pain has persisted in his left shoulder today.  Mom has tried Tylenol by mouth and topical lidocaine patches with some improvement of his pain.  Mom took child to Emergency Department. He also complains of persistent left testicular and right hip pain, which he had been seen in the ED the day prior for.  Mother reports he is also being evaluated for possible rheumatoid arthritis.  She states she brought him back to the ER tonight because he took a nap this evening  (06/14/25) which is highly unusual for the patient.  She had been checking his temperature throughout the day today and noticed at 7 PM that he had a rectal temperature of 105.1.  She did not provide any antipyretics and came went to the ER.  Mother states that his doctors and specialists are all in another area as she did not feel satisfied with the care he was receiving in this area in the past.  Patient denies any cough, shortness of breath, chest pain, abdominal pain, sore throat, congestion or runny nose.  There has been no nausea vomiting diarrhea or constipation.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Somnolence, Testicular pain, Ultrasound testes, Urine analysis, X-ray limb
Clinical narrative: He had his pneumococcal 23 vaccine Thursday, June 12.  He had the vaccine in his left arm.  He woke up the following day complaining of left arm pain, though mom thought this was just because of his recent vaccine.  The pain has persisted in his left shoulder today.  Mom has tried Tylenol by mouth and topical lidocaine patches with some improvement of his pain.  Mom took child to Emergency Department. He also complains of persistent left testicular and right hip pain, which he had been seen in the ED the day prior for.  Mother reports he is also being evaluated for possible rheumatoid arthritis.  She states she brought him back to the ER tonight because he took a nap this evening  (06/14/25) which is highly unusual for the patient.  She had been checking his temperature throughout the day today and noticed at 7 PM that he had a rectal temperature of 105.1.  She did not provide any antipyretics and came went to the ER.  Mother states that his doctors and specialists are all in another area as she did not feel satisfied with the care he was receiving in this area in the past.  Patient denies any cough, shortness of breath, chest pain, abdominal pain, sore throat, congestion or runny nose.  There has been no nausea vomiting diarrhea or constipation.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: THE PATIENT PRESENTED TO THE PHARMACY, AND SHOWED US HER ARM, WHICH WAS RED AT INJECTION AREA, ITCHY, AND WARM. WE RECOMMENDED PATIENT TAKE BENADRYL, AND MONITOR FOR IT TO WORSEN AND CALL DR IF IT DOES.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site induration, Injection site pain, Nausea, Pain
Clinical narrative: Later on the same day as the vaccine, patient developed tactile fever, chills, nausea and immunization site pain. She felt better the following day other than some arm pain at the immunization site. She presented to the office the next day, two days after the vaccine, with complaint of increased pain in her arm near the injection site and pain with arm movement. Area was indurated but not warm or erythematous.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Skin warm
Clinical narrative: Later on the same day as the vaccine, patient developed tactile fever, chills, nausea and immunization site pain. She felt better the following day other than some arm pain at the immunization site. She presented to the office the next day, two days after the vaccine, with complaint of increased pain in her arm near the injection site and pain with arm movement. Area was indurated but not warm or erythematous.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Influenza
Clinical narrative: Consumer reported that she showed no immunity towards Varicella after the titer and VARIVAX vaccination series.; Consumer reported getting the Flu after receiving her second dose of the VARIVAX vaccine; she received her second dose of the VARIVAX vaccine on 06/18/2024 and completed a Varicella titer for nursing school; This spontaneous report was received from 31-year-old female referring to herself. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.    On 18-Jun-2024, the patient was vaccinated with the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), reconstituted with sterile diluent (MERCK STERILE DILUENT) (formulation, strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age) (conflicting information: patient also reported completing the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) vaccination series when she was younger but did not elaborate further).    On an unknown date, the patient got the flu after receiving her second dose of the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) vaccine. On an unknown date, the patient completed a Varicella titer for nursing school, it showed no immunity towards Varicella after the titer and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) vaccination series.    At the reporting time, the outcome of events flu and Varicella titer showed no immunity was not provided. Action taken with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was not applicable.    The causal relationship between the events and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) with reconstituted sterile diluent (MERCK STERILE DILUENT) was not provided.  Lot# is being requested and will be submitted if received.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Dizziness, Fall, Head injury, Headache
Clinical narrative: Per mother patient fell and hit her head on the wall. Noted patient had bump on forehead on the left side. C/O dizziness and headache. Ice pack applied to patient forehead. Vital: BP: 145/94, pulse: 97, O2 98%, BG: 110mg/dl. Patient alert and oriented X4. Patient received HPV, Tdap and MCV vaccines. Stated she didn't had any breakfast. Rechecked vitals after 5 mins  BP:127/85. MD assessed patient and advice sent patent out to ER for further evaluation for headache and dizziness. Call 9-1-1 patient sent to ER approx at 11:21am. Family will follow the ambulance.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: Per mother patient fell and hit her head on the wall. Noted patient had bump on forehead on the left side. C/O dizziness and headache. Ice pack applied to patient forehead. Vital: BP: 145/94, pulse: 97, O2 98%, BG: 110mg/dl. Patient alert and oriented X4. Patient received HPV, Tdap and MCV vaccines. Stated she didn't had any breakfast. Rechecked vitals after 5 mins  BP:127/85. MD assessed patient and advice sent patent out to ER for further evaluation for headache and dizziness. Call 9-1-1 patient sent to ER approx at 11:21am. Family will follow the ambulance.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reports severe pain starting two days after vaccination in the arm of vaccination. She "just dealt with it". It has since subsided to an ache, but she still experiences the pain a month and a half later. I advised her to be seen so she can be evaluated for SIRVA.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Brain fog, Fatigue
Clinical narrative: Pt developed brain fog and generalized fatigue about 8hrs after the administration of shingrix vaccine.
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Incorrect product storage; This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-Jun-2025, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2096661, expiration date: 07-Mar-2026) administered by Oral route.   On 17-Jun-2025, the patient experienced Incorrect product storage (35.4F for 0 hours 48 minutes 0 seconds. There was no previous temperature excursion. No adverse event was reported.; Reporter's Comments: Keywords : BP
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; HCP called and reported inadvertent administration of PROQUAD to a 6-month-old patient. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a Nurse Practitioner and refers to a(n) 6-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-Jun-2025, the patient was inadvertently vaccinated with the dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event).
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No adverse event; HCP called and reported inadvertent administration of PROQUAD to a 6-month-old patient. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a Nurse Practitioner and refers to a(n) 6-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-Jun-2025, the patient was inadvertently vaccinated with the dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event).
Vaccine: DTPPVHBHPB, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; report inadvertent administration of ROTATEQ and VAXELIS after a temperature excursion; This spontaneous report was received from a nurse practitioner and refers to a 5-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 07-MAY-2025, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# not reported) underwent a temperature excursion (1.4 degree Celsius, 18 minutes). There was no previous temperature excursions.  On 21-MAY-2025, the patient was inadvertently vaccinated with improperly stored diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis b [recombinant] vaccine (VAXELIS) suspension for injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution administered by oral route (dose, lot # and expiration date were not reported) for prophylaxis (Product storage error). No additional adverse event was reported (No adverse event).  Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on torso and arms; This non-serious case was reported by a consumer and described the occurrence of rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-JUN-2025, the patient received the 1st dose of Shingrix. On 08-JUN-2025, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash on torso and arms). The outcome of the rash was not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2025 The patient had rash on torso and arms. It was reported that online review stated that rash is a rare situation with this vaccine, was not rare for the patient.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Rash erythematous, Vaccination failure
Clinical narrative: had shingles in June 2025/ red rash in a line on left side of abdomen; Suspected vaccination failure; in late February 2025 she was diagnosed with shingles/ a red rash on left back torso; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10-JAN-2019, the patient received the 2nd dose of Shingrix (left arm). On 06-NOV-2018, the patient received the 1st dose of Shingrix (left arm). In FEB-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: in late February 2025 she was diagnosed with shingles/ a red rash on left back torso). In JUN-2025, the patient experienced shingles (Verbatim: had shingles in June 2025/ red rash in a line on left side of abdomen). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-JUN-2025 The patient self-reported this case for herself. The patient had other conditions and used other products. The patient reported that she received Shingrix dose 1 and dose 2 both in left arm. She stated in late February 2025 she was diagnosed with shingles. She had a red rash on left back torso. She was given an antiviral for 10 days. At the time of reporting, she was out of town and stated she had red rash in a line on left side of abdomen. She would refer to HCP (health care professional) when she gets back home. This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).