chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired vaccine (Vaqta Hep A) on 05/16/2025 that expired on 05/11/2025. no signs or symptoms after the administration.  patient was observed for 15 minutes with no signs or symptoms. patient was advised to call the office if they experience any symptoms. patient verbalized understanding.
Age: 35.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Underdose
Clinical narrative: The incorrect dose (Engerix-B, 10 mcg / 0.5ml) was prepared and administered rather than the adult dose 20 mcg/1mL Engerix-B
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Pustule, Rash, Urticaria
Clinical narrative: PATIENT DEVELOPED RASH ON STOMACH AND WELTS WITH PUS
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: pt felt woozy and lightheaded and faint
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Nausea, Vomiting
Clinical narrative: Patient received PCV20 vaccine and then about 5 minutes after receiving vaccine patient began to feel nauseous and vomited multiple times. After vomiting patient felt better and waited the 15 minutes in clinic and all symptoms resolved. Patient went home.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: pt felt  woozy, dizzy and lightheaded
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: THE WIFE CALLED ME TODAY TO REPORT THAT OVER THE PAST 4 WEEKS THE PATIENT HAS DEVELOPED A SWOLLEN AREA AROUND SITE OF INJECTION AND A BURNING FEELING THAT HAS NOT GONE AWAY.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Bladder disorder, Mobility decreased
Clinical narrative: Vaccine received 5/9/25 at noon.  At 2 am 5/10/25 I was unable to move my legs and had no control over my bladder.  By 10:30 am feeling had returned.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Brain fog, Cholecystectomy, Cholecystitis
Clinical narrative: Nausea, vomiting, pain at injection site. Vision issues, blurry, cloudy vision, neurological issues, brain fog, balance issues, vertigo ,  iBS, stress, anxiety, food intolerance,  chronic  gall bladder inflammation, gall bladder removal 2025, liver cysts,
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Food intolerance, Hepatic cyst, Injection site pain, Irritable bowel syndrome, Nausea
Clinical narrative: Nausea, vomiting, pain at injection site. Vision issues, blurry, cloudy vision, neurological issues, brain fog, balance issues, vertigo ,  iBS, stress, anxiety, food intolerance,  chronic  gall bladder inflammation, gall bladder removal 2025, liver cysts,
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Stress, Vertigo, Vision blurred, Visual impairment
Clinical narrative: Nausea, vomiting, pain at injection site. Vision issues, blurry, cloudy vision, neurological issues, brain fog, balance issues, vertigo ,  iBS, stress, anxiety, food intolerance,  chronic  gall bladder inflammation, gall bladder removal 2025, liver cysts,
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, pain at injection site. Vision issues, blurry, cloudy vision, neurological issues, brain fog, balance issues, vertigo ,  iBS, stress, anxiety, food intolerance,  chronic  gall bladder inflammation, gall bladder removal 2025, liver cysts,
Age: 51.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Patient states that she got redness that looks like a rash and a little bit of warmth in the injection site of right arm. She just started having symptoms yesterday.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema
Clinical narrative: Severe eczema flare up that persists 18 months after vaccination. Patient had previous diagnosis of ectopic dermatitis or numular eczema.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: Date: May 16, 2025    1. Incident Summary  On May 16, 2025, at approximately 10:00AM, I administered a Hepatitis B (Heplisav-B) vaccination to patient at Pharmacy. Prior to administration, I conducted a full profile review and a Drug Utilization Review (DUR), confirming no contraindications, no active prescription on file, and no DUR rejections. The prescription record for the first dose was marked ?deactivated,? leading me to believe patient had not yet received her initial vaccination. Even the patient did not say anything and asked my tech so Hep B vaccine. My tech told me she needs Hep B vaccine.     2. Discovery of Prior Dose  Hours after administration, the Pharmacy Manager notified me by a phone call to the pharmacy that patient had, in fact, received her first Hep B dose on May 15, 2025. Neither the patient nor my pharmacy technician informed me of that prior administration, likely due to the prescription?s deactivated status in our system. As a result, patient inadvertently received her second dose 29 days after her first, instead of at the manufacturer-recommended interval of 28 days.    3. Actions Taken & Procedural Compliance  I performed all standard checks: patient identity, vaccination history, and DUR, with no system alerts or overrides required. I adhered strictly to the ACIP guidelines for Hepatitis B administration based on the information available. I documented the administration of the May 16 dose in patient?s profile immediately after the procedure.  4. Immediate Risks & Regulatory Implications  This event constitutes a misfill and deviation from the recommended dosing schedule, which may:  Compromise vaccine efficacy and patient safety. Expose the pharmacy to regulatory scrutiny and potential licensure risk under Board of Pharmacy standards. Violate internal quality assurance protocols regarding prescription activation/deactivation procedures.   5. Required Investigation & Corrective Measures  To protect patient health and the integrity of our pharmacy operations, I request an immediate, in-depth investigation into:  Who administered the first Heplisav-B dose on May 15, 2025, and under what prescription or documentation. Why the original prescription was deactivated in the system without clinical notation or DUR alert. Whether system settings or staff workflows inadvertently allowed the deactivation to override critical vaccination history.   I fulfilled my professional duty by relying on the system records available at the time. I expect a prompt response outlining the investigation?s findings and the measures that will be implemented to safeguard both our patients and our license compliance.    Thank you for addressing this matter with the urgency it requires.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia
Clinical narrative: When she woke up on 3/4/25 in the morning, she noticed that both her hands were tingling.  She received the first HPV shop on 3/3/25 in the left deltoid. At the same time she had recently finished treatment with metronidazole for bacterial vaginosis.  This was reported to VAERS on 5/16/2025 and patient was told not to take HPV vaccines in future due to component / contra indications regarding yeast as mentioned in the package insert.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HEPA, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received an adult dose (20mL) of Hepatitis B instead of the pediatric dose of (10mL). Provider followed up with mom. No side effects were detected by parent.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fungal infection, Infection parasitic
Clinical narrative: Hairloss missing teeth systemic disorder Blau syndrome harmful bloom algae KL gene mutation many different gene mutations
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Blau syndrome, Environmental exposure, Gene mutation, Tooth loss
Clinical narrative: Hairloss missing teeth systemic disorder Blau syndrome harmful bloom algae KL gene mutation many different gene mutations
Sex: F
Vaccine: UNK
Symptoms: Antibody test abnormal
Clinical narrative: Antibody test abnormal; This spontaneous report was received from a Physician and refers to an Elderly female patient in her 70's. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (manufacturer unknown) (lot #, expiration date, strength, route of administration, anatomical location not provided) as "routinely pneumonia" (pneumonia immunization).   On an unknown date, the patient had low antibody results with the vaccine (Antibody test abnormal), as the test showed "low" for 20 of serotypes and "low-normal" for serotypes 34, 43 and 57. At the reporting time, the outcome of Antibody test abnormal was unknown. It was stated that was unclear if there were any other adverse effects.   The causal relationship between the event of Antibody test abnormal and Pneumococcal 21-valent Conjugate Vaccine (manufacturer unknown) was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02794485-02794481 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ZHRHRYA5|25042025160011|8489 , Central date : 2025-04-25 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2280124 , MNSC case number : 02794485 , MNSC interaction number : 02794481 , Integration log UniqueID : 500UW00000ZHRHRYA5|25042025160011|8489 , Service cloud CaseID : 500UW00000ZHRHRYA5
Age: 20.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No symptomatic Adverse Events were reported.; received his first dose of RECOMBIVAX HB at 20 years old (2 years ago, exact date unknown). The patient did not receive their second dose until yesterday (04/30/2025); This spontaneous report was received from a healthcare professional (HCP, also reported as "physician assistant") concerning an approximately 22-year-old male patient.   His medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. The patient was previously unvaccinated as a child.  On unspecified date in approximately 2023 (reported as "2 years ago"), at 20-year-old, he was vaccinated with the 1st dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), 1 dosage form (anatomical location, route of administration, lot # and expiration date were not reported). The patient did not receive his 2nd vaccination until 30-Apr-2025 (also reported as "yesterday"), when he was vaccinated with Hepatitis B Vaccine (Recombinant) injection pre-filled syringe (batch/lot number X023303 has been verified to be a valid batch lot number for Hepatitis B Vaccine [Recombinant], expiration date reported and upon internal validation established as 17-May-2026), dose number 2, 1 mL administered by a health professional (anatomical location and route of administration were not provided) (inappropriate schedule of product administration). Both doses were administered as prophylaxis.  No symptomatic adverse events were reported (no adverse event). No additional information reported.   Lot # is being requested and will be submitted if received.
Vaccine: HEPA, HEPA
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AEs; Caller reported a Patient received her 1st dose of VAQTA on 5/21/2024 and 2nd dose on 11/14/2024.  The 2nd dose was administered 1 week too early.  The Lot and expiration information under product tab is for the 2nd dose as that is the dose involved; This spontaneous report was received from a nurse 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 21-May-2024, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis (Lot No., expiration date, exact quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On 14-Nov-2024, the patient was vaccinated with the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) 0.5 mL, strength reported as 25/0.5, administered intramuscular on the left thigh as prophylaxis (Lot No. Y007472 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated], expiration date reported and upon internal validation established as 19-Oct-2025) (vaccination scheme frequency was not provided). It was stated that the second dose was administered 1 week too early (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event).
Age: 12.0
Sex: M
Vaccine: MEN, MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: MENQUADFI was reconstituted with an MMR Varicella vaccine's diluent and was given to a patient with  no AE; Initial information received on 13-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who received meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was reconstituted with measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine diluent with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) and HPV vaccine both for Immunisation.  On 13-May-2025, the patient received 0.5 ml of dose 1 of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength- standard, expiry date- 30-APR-2028 and lot U8375AA) once via intramuscular route in the left deltoid for Immunization was reconstituted with measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine not produced by Sanofi Pasteur (formulation, strength, expiry date and lot number not reported) diluent with no reported adverse event (product preparation error) (latency- same day).   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: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: 11-year-old patient received an expired ADACEL, with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old male patient who received an expired diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi); and hpv vaccine vlp rl1 4v (yeast) (gardasil) for Immunisation.  On 13-May-2025, the patient received an expired 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (Strength- standard and frequency- once) lot 2CA56C1 and expiry date- 12-MAY-2025 via intramuscular route in the left deltoid for Immunisation with no reported adverse event (expired product administered) (latency- same day).  Action taken- 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: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event; patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who had experienced an event was not given the full dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] vaccine, as some of the medication spilled down the arm of the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox), (Menquadfi); and HPV vaccine VLP rL1 4v (yeast) (Gardasil).  On 14-May-2025, the patient received a less than 0.5 ml dose once (1x) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine suspension for injection (batch number: 3CA17C1, expiry date: 28-Feb-2026)  via intramuscular route in the left deltoid for prophylactic vaccination.  On 14-MAY-2025 the patient was not given the full dose, as some of the medication spilled down the arm of the patient with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency: 1 day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  Action taken:  not applicable.  It was not reported if the patient received a corrective treatment for both the events   At time of reporting, the outcome was Unknown for both the events.  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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Computerised tomogram abnormal, Hypoaesthesia, Magnetic resonance imaging head abnormal, Transient ischaemic attack
Clinical narrative: Pt received the covid vaccine on 4/17/2025.  She had some vertigo starting on 4/18.  On 4/24 She went to the Emergency Department on 4/24 with numbness in left arm, up through her face near her eye.  Her blood pressure was fluctuated very widely.  She was diagnosed with a TIA, and possibly 2 earlier mini stokes found on Catscan and MRI.  On 5/8 she had a follow up with neurology, but we did not received a further update.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Pt received the covid vaccine on 4/17/2025.  She had some vertigo starting on 4/18.  On 4/24 She went to the Emergency Department on 4/24 with numbness in left arm, up through her face near her eye.  Her blood pressure was fluctuated very widely.  She was diagnosed with a TIA, and possibly 2 earlier mini stokes found on Catscan and MRI.  On 5/8 she had a follow up with neurology, but we did not received a further update.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Eye pruritus, Lip swelling
Clinical narrative: Swollen Lips/eyes itchiness
Age: 72.0
Sex: F
Vaccine: CHIK
Symptoms: Arthralgia, Headache, Malaise, Pyrexia
Clinical narrative: fever up to 104 x 2 days; joint aches; headaches; malaise
Age: 78.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient called pharmacy reporting that her arm was red and swelling. Eventually, patient went to the ER where she was provided with an Rx sent to my pharmacy for cephalexin 500 mg (1 QID for 7 days). It appears patient was being treated for cellulitis.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Febrile convulsion, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Febrile seizure on 5/16/25 at 9:30.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Febrile convulsion
Clinical narrative: Complex Febrile Seizure
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular
Clinical narrative: About 9 hours after vaccination my heart beat became very erratic. It bounced from 120s to 50s and back within a couple minutes, and did so for 5 hours (7 pm - midnight). When I realized why it was happening, likely vaccine reaction, I decided to wait and see what happened. I had just received thorough heart tests in March with good results. But if it had gone on for much longer I would have gone to ER. Told my family doctor, Dr, at appointment this week. Plan to talk with cardiologist at next appointment. Concerned about future vaccinations, especially another Moderna COVID.  It took the next day  and a half to recover from extreme fatigue caused by erratic heart beat.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Cellulitis, Local reaction, Skin warm, Swelling
Clinical narrative: Mild swelling and warmth started the night after getting vaccines. Seen two days later, local reaction vs. cellulitis. Started on cephelexin and cetirizine.
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Decreased appetite, Pain
Clinical narrative: PT REPORTED SIDE EFFECTS 2 WEEKS AFTER RECEIVING THE VACCINES; LOSS OF APETITE & BODY ACHES
Age: 68.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site paraesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient contacted us to evaluate her for left upper extremity pain and paresthesias that started less than 24 hours after she received dtap in her left deltoid region. Symptoms started the day after the shot and initially involved her entire arm from site to her fingers and interrupted her sleep, not relieved with Tylenol. She states it does not feel like the CRPS symptoms she tends to get in her right hand. Does not feel like neuropathy she gets in her right foot.  After 24 hours she reports it improved somewhat and only now involves her forearm and hand on the left. She has waited 4 days to see if it got better and it is not improving now. She is concerned it is related to the dtap injection as it started shortly after receiving it.  She had pain to touch in the left arm and forearm, pain with movement of the extremity. She was able to move through a rom but painful. Temperature difference is present with the left upper extremity cooler than the right upper extremity. Strength is hindered by pain. Prescribed Prednisone 20mg qd x 5 days, Tylenol.
Age: 68.0
Sex: F
Vaccine: DTAP
Symptoms: Peripheral coldness, Sleep disorder, Tenderness
Clinical narrative: Patient contacted us to evaluate her for left upper extremity pain and paresthesias that started less than 24 hours after she received dtap in her left deltoid region. Symptoms started the day after the shot and initially involved her entire arm from site to her fingers and interrupted her sleep, not relieved with Tylenol. She states it does not feel like the CRPS symptoms she tends to get in her right hand. Does not feel like neuropathy she gets in her right foot.  After 24 hours she reports it improved somewhat and only now involves her forearm and hand on the left. She has waited 4 days to see if it got better and it is not improving now. She is concerned it is related to the dtap injection as it started shortly after receiving it.  She had pain to touch in the left arm and forearm, pain with movement of the extremity. She was able to move through a rom but painful. Temperature difference is present with the left upper extremity cooler than the right upper extremity. Strength is hindered by pain. Prescribed Prednisone 20mg qd x 5 days, Tylenol.
Age: 19.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Dysarthria, Hypotonia, Unresponsive to stimuli
Clinical narrative: About 1 to 2 minutes after vaccine administration, pt reported feeling dizzy. As we spoke to him further, pt slumped over and started slurring his words. Then he stopped responding altogether and passed out. I heard hard breathing from him and pt became very pale. I administered an Epipen 0.3mg to patient and within 30 seconds or so, pt became responsive and woke up again. Pt immediately questioned what was going on and said he remembered nothing after feeling like he was going to pass out. Paramedics were called and by the time paramedics came, pt was fully responsive. Pt had started shivering from Epipen use. Pt was taken to hospital and I spoke to pt's father today and he states pt is back to normal and no further adverse effects were noted.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Peripheral swelling
Clinical narrative: Less than 24 hours after vaccine -  fatigue  vomiting, severe joint pain, fever, headache, muscle aches, swelling in legs and feet.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Less than 24 hours after vaccine -  fatigue  vomiting, severe joint pain, fever, headache, muscle aches, swelling in legs and feet.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia
Clinical narrative: Patient was describing shoulder joint pain around 24 hours after receiving dose 1. She stated that the pain has not subsided in seven days. The patient has not used any over the counter medications to help with the pain. The patient also stated that it didn't seem like the vaccine was given too high based on the bandage placement.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Temperature 99.4, stream fatigue, throughout body, muscle aches, shivering at bedtime.
Age: 77.0
Sex: F
Vaccine: PNC21
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient called 5.17.25 and stated that they got the Capvaxive vaccine 5.10.25 and by 5.13.25 the patient said her arm started swelling and itching - patient states it is still swollen and itching as of today - patient has only tried rubbing alcohol on the spot, but will try some itching cream, benadryl, and a cold compress. I told patient that if it got worse, spread, or did not resolve to go visit PCP for follow-up
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient called the pharmacy on 5/16/25 worried that her arm was infected. She complained of warmth at the injection site, a hard lump, and pink color. I asked if she had tried ice or Tylenol and she had not. She stated that she had never had a reaction before. I suggested she call her primary care if it got worse and asked her to call us and follow up if anything changed. I did not hear back from her.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness at injection site even after 25 days
Age: 50.0
Sex: M
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Cough, Headache, Oropharyngeal discomfort, Pain, Pyrexia
Clinical narrative: Fevers up to 103, chills, systemic body aches, headache, tickle/burn down throat/ some coughing.  These come and go, with me feeling fairly normal part of the day, then fever spikes, seeming to be getting worse every day.   With it going up to 103° today, this is quite concerning
Age: 50.0
Sex: M
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Throat irritation
Clinical narrative: Fevers up to 103, chills, systemic body aches, headache, tickle/burn down throat/ some coughing.  These come and go, with me feeling fairly normal part of the day, then fever spikes, seeming to be getting worse every day.   With it going up to 103° today, this is quite concerning
Age: 66.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Red, hot painful rash began shortly after shot and has continued for 3 days, increasing in severity.  Rash on right bicep, approx fist size.
Age: 0.42
Sex: F
Vaccine: DTAP, PNC20, RV5
Symptoms: Diarrhoea, Infant irritability, Pyrexia
Clinical narrative: Fever 5/15 starting 7pm that resolved by 5/16 9am. Mild diarrhea during fever. Fussy 5/17 after 7pm.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac pacemaker insertion, Condition aggravated
Clinical narrative: Approximately 3-5 days after my second Pfizer COVID-19 vaccine my Atrial Fibrilation became uncontrollable with medication.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Acoustic stimulation tests normal, Anxiety, Blood test normal, Computerised tomogram head normal, Laboratory test normal
Clinical narrative: On 3/31/25, five days after vaccine. Had vertigo and ringing in Left ear which then caused anxiety. Went to nearest emergency room who did blood tests, cardiac enzymes, CT brain and monitored. Tests and labs negative, normal and was discharged home. Follow up with Primary care  and two ENT since vertigo/ Left ear ringing continued.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Magnetic resonance imaging normal, Myocardial necrosis marker normal, Tinnitus, Vertigo
Clinical narrative: On 3/31/25, five days after vaccine. Had vertigo and ringing in Left ear which then caused anxiety. Went to nearest emergency room who did blood tests, cardiac enzymes, CT brain and monitored. Tests and labs negative, normal and was discharged home. Follow up with Primary care  and two ENT since vertigo/ Left ear ringing continued.
Age: 45.0
Sex: F
Vaccine: COVID19, HEPAB, HPV9
Symptoms: Expired product administered
Clinical narrative: patient received expired comirnaty vaccine (expired 4/19/25) given 5/15/25
Age: 54.0
Sex: M
Vaccine: COVID19, FLU3, UNK
Symptoms: C-reactive protein, Computerised tomogram, Differential white blood cell count, Full blood count, Magnetic resonance imaging head
Clinical narrative: Lost use of left foot.  Cannot move it side to side or up and down.  Diagnosed as Foot Drop'.  Needs a cane or walker to safely walk. Had 3 days of steroid infusions on 5/8, 5/9 & 5/10.  On 5/14 had a steroid injection and is taking 6 days of oral steroids. He will be seen by a neurologist next week and will start physical therapy soon.  He currently is doing his own stretching exercises to keep his foot from curling permenantly.  #17 Shingles (Shingrix - Glaxosmit). (this was not shown on the drop down list.
Age: 54.0
Sex: M
Vaccine: COVID19, FLU3, UNK
Symptoms: Metabolic function test, Peroneal nerve palsy, Red blood cell sedimentation rate, Walking aid user
Clinical narrative: Lost use of left foot.  Cannot move it side to side or up and down.  Diagnosed as Foot Drop'.  Needs a cane or walker to safely walk. Had 3 days of steroid infusions on 5/8, 5/9 & 5/10.  On 5/14 had a steroid injection and is taking 6 days of oral steroids. He will be seen by a neurologist next week and will start physical therapy soon.  He currently is doing his own stretching exercises to keep his foot from curling permenantly.  #17 Shingles (Shingrix - Glaxosmit). (this was not shown on the drop down list.
Age: 64.0
Sex: M
Vaccine: DTAP
Symptoms: Blood test normal, Dizziness, Hypoacusis, Irritability, Pain
Clinical narrative: Dizziness, sleepiness, aches/pains, throwing up, followed by Vertigo. Eyesight issues, hearing issues.  Saw Dr on 5/2/25, conducted exam and bloodwork.  Outcome: fussiness, eyesight, hearing and irritability persist.
Age: 64.0
Sex: M
Vaccine: DTAP
Symptoms: Somnolence, Vertigo, Visual impairment, Vomiting
Clinical narrative: Dizziness, sleepiness, aches/pains, throwing up, followed by Vertigo. Eyesight issues, hearing issues.  Saw Dr on 5/2/25, conducted exam and bloodwork.  Outcome: fussiness, eyesight, hearing and irritability persist.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient developed a severe rash later in the day and went to the emergency room
Age: 65.0
Sex: M
Vaccine: PNC21
Symptoms: Dyspnoea, Mobility decreased
Clinical narrative: Pt received the vaccine and had trouble breathing and going up stairs.
Age: 69.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: After vaccination, patient has experienced tingling  from his upper arm at the vaccination site down to his wrist
Age: 48.0
Sex: M
Vaccine: HEPAB, PNC20, TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Patient stated he experienced right shoulder pain for a week, then after that, stiffness in the arm and decreased range of motion. He states that if he tries to stretch further out, he experiences some pain
Age: 19.0
Sex: F
Vaccine: MNP
Symptoms: Dermal filler reaction, Lip swelling, Pain, Swelling
Clinical narrative: Localized swelling and pain, then patient developed granuloma-like swelling in one area of her lip where she had filler previously the following Sunday AM.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Computerised tomogram, Head discomfort, Headache, Hypoaesthesia oral
Clinical narrative: Hours after receivig the third does of tthe COVID-19 vaccine to the present, I've had persistent daily headaches with no relief. I wake up in pain and go to sleep in pain. The pain is centered around and above my eye sockets and presents itself as this contact pressure at a migraine level. During intense episodes, the pain radiates into my nose and the roof of my mouth, causing numbness in the upper palate. I've seen many physicians and specialists over the years- my primary care doctor on a consistent basis, ear nose and throat specialist where I got a CAT scan and a biopsy; MRI of my brain from Dr., neurologist; dentist and root canal specialist, eye specialist.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Oral pain, Pain, Periorbital pain, Rhinalgia
Clinical narrative: Hours after receivig the third does of tthe COVID-19 vaccine to the present, I've had persistent daily headaches with no relief. I wake up in pain and go to sleep in pain. The pain is centered around and above my eye sockets and presents itself as this contact pressure at a migraine level. During intense episodes, the pain radiates into my nose and the roof of my mouth, causing numbness in the upper palate. I've seen many physicians and specialists over the years- my primary care doctor on a consistent basis, ear nose and throat specialist where I got a CAT scan and a biopsy; MRI of my brain from Dr., neurologist; dentist and root canal specialist, eye specialist.
Vaccine: DTAP, HIBV, PNC20, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported. No additional AE; administration of PEDVAX HIB after expiration date. HCP reports the PEDVAX HIB had an expiry date of 05/10/2025 and the expired vaccine was inadvertently administered to a patient on 05/13/2025; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 13-MAY-2025, the patient was inadvertently vaccinated with an expired dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), administered as prophylaxis (lot number W028534 has been verified to be valid for Haemophilus b Conjugate Vaccine [Meningococcal Protein Conjugate] [LIQUID PEDVAX HIB], expiration date 10-MAY-2025; dose, formulation, vaccination scheme frequency, anatomical site of injection and route of administration were not provided). The healthcare professional (HCP) reported that there was no temperature excursion (TE) for the administered vaccine, and that post expiry memo supported potency of the dose. No symptoms and no additional adverse event were reported for the patient. No further details.
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Caller reported AE on behalf of a patient who was administered a third dose of GARDASIL 9 before the recommended interval. Patient was administered dose 1 on 10/25/2024, dose 2 on 12/6/2024, and dose 3 on 2/7/2025. No symptoms reported. No additional; no adverse event; This spontaneous report was received from a medical assistant and refers 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 25-Oct-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection as prophylaxis (dose, lot #, expiration date, anatomical location , and route of administration were not reported). On 06-Dec-2024, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection, as prophylaxis (dose, lot #, expiration date, anatomical location, and route of administration were not reported). On 07-Feb-2025, the was vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9), Recombinant Suspension for injection (lot #Y014510, expiration date: was reported as 20-Sep-2025, but upon validation it was found to be 01-Nov-2026) 0.5 mL (0.5ml/dose). Per reporter, the patient received this last dose before the recommended interval (Inappropriate schedule of vaccine administered). No symptoms reported.  Lot # is being requested and will be submitted if received.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The first dose had been given on February 7, 2025, and the second dose had been given on May 9, 2025, six months earlier; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a 54-year-old male patient who received HAV (Havrix adult) (batch number 2345b, expiry date 02-FEB-2026) for prophylaxis.   Concurrent medical conditions included fatty liver, hypertension and sleep disorder. Concomitant products included Hepatitis a vaccine inact (Havrix) and amitriptyline.   On 09-MAY-2025, the patient received Havrix adult (left deltoid). On 09-MAY-2025, an unknown time after receiving Havrix adult, the patient experienced drug dose administration interval too short (Verbatim: The first dose had been given on February 7, 2025, and the second dose had been given on May 9, 2025, six months earlier). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK Receipt Date: 09-MAY-2025 The first dose had been given on 7th February 2025, and the second dose had been given on 9th May 2025, six months earlier, which led to Drug dose administration interval too short. No symptoms had been recorded.
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix is mixed with a plain diluent; Shingrix is mixed with a plain diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix is mixed with a plain diluent) and inappropriate dose of vaccine administered (Verbatim: Shingrix is mixed with a plain diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 08-May-2025 Physician asked that Shingrix was mixed with a plain diluent and not the one it comes with, what should they do. When the Medical Information Specialist tried to clarify if that was a hypothetical question or a real scenario, visitor ended the chat, so the Adverse Event report was being send as a preventive measure, only for awareness, since it might be a potential administration of Shingrix after reconstitution with an unapproved diluent. Reporter did not clarified what type of Healthcare Provider they were, and they declined consent to record their contact details into the system. Shingrix reconstituted with plain diluent instead of the supplied liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient was only given the liquid; patient was only given the liquid; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 59MC4, expiry date 10-MAR-2027) for prophylaxis.   On 13-MAY-2025, the patient received the 1st dose of Shingrix. On 13-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was only given the liquid) and inappropriate dose of vaccine administered (Verbatim: patient was only given the liquid). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 13-MAY-2025 The healthcare professional stated that on the day of reporting another staff member prepared the dose to be administered to a male patient, and the staff member did not know it was two vials, so the patient was only given the liquid. She confirms this was intended to be the first dose of the series, and this occurred this morning, 13 May 2025. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles after finishing series; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles after finishing series). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-MAY-2025 On 13th May 2025, a pharmacist called to inform that the patient had completed the Shingrix series back in 2017.  He had developed shingles one year later. This case was considered as suspected vaccination failure as details regarding 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  laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix."
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 15 months old female patient received a dose of Boostrix; A 15 months old female patient received a dose of Boostrix; A 15 months old female patient received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 235DZ, expiry date 10-JAN-2027) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received Boostrix and DTaP vaccine. On an unknown date, an unknown time after receiving Boostrix and not applicable after receiving DTaP vaccine, the patient experienced wrong vaccine administered (Verbatim: A 15 months old female patient received a dose of Boostrix), accidental underdose (Verbatim: A 15 months old female patient received a dose of Boostrix) and inappropriate age at vaccine administration (Verbatim: A 15 months old female patient received a dose of Boostrix). The outcome of the wrong vaccine administered, accidental underdose and inappropriate age at vaccine administration 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: 14-MAY-2025 A Medical Assistant called to report that a 15 months old patient received by mistake Boostrix instead of the DTaP vaccine, which led to inappropriate age at vaccine administration, wrong vaccine administered and accidental underdose. It was the 4th dose for the patient because the patient has already 3 previous doses of DTaP. The reporter asked if they had any information regarding this situation. The reporter consented to follow up.