chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Rash macular
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reports later in day after Capvaxive immunization, felt flu like body/joint aches as well as develpoed splotchy rash down arm of vaccine. Day after vaccine was the worst then started to improve somewwhat day after that. Still achy and splotch rash although improved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Additional Details: Patient stated that she experienced the usual achiness and mild fever. She did not feel like doing anything and all symptoms only lasted for 1 day
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Pt reported infection at injection site, described having a large pustule with green fluid that burst, pain and redness and fluid leakage. Pt did see doctor in-person during a follow up in which no antibiotics were prescribed at the time, per patient the doctor believes it is healing on its own.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Asthenia, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Systemic: Fever-Medium, Systemic: Sore Throat/Loss of voice-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium
Age: 64.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Aphasia, Ear discomfort, Headache, Memory impairment, Skin discolouration
Clinical narrative: About 10 later my tongue started swelling up and i was talking funny. I then noticed a piece of skin on it that turned grey and it came right off. And i was looking in the mirror at my tongue and it was about as round as my little finger and it was deep.  And they told me to gargle with that water and peroxide after a couple of days it started to go away.  I stopped doing it for a couple of days and then it started coming back. So i did it again and made sure i did it right and it went away. I found that my short term memory was really bad and i couldn't remember what in front of me. I even forgot my doctor where he was located and what he looked liked. I looked at his card and knew it was my doctor but couldn't remember anything else, I had to go to the store and had them look up his address and gave me directions to the doctor and i went down there but it was a Saturday and it wasn't open. I did sleep for more than 3 days and told me he couldn't given me anything because of the medications I am on. But i told him i need something now i haven't slept, something is wrong. He did end up getting me a prescription for Quietin or something like that and i had to take 2. I tried to take one but i hated how it made me feel. Then all around my eyes went black and they stay black now and it looks someone punched me in both eyes.  The top of my head was bothering me and it wasnt like a headache but it hurt. And thats when i had to go get some aspirin.  My tendons in my fingers began to hurt and they felt tight and they would sting when i would try and move my fingers. I have trouble in conversation to find the words i need to speak. My right ear feels like its infected.
Age: 64.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Skin exfoliation, Sleep disorder, Swollen tongue, Tendon pain
Clinical narrative: About 10 later my tongue started swelling up and i was talking funny. I then noticed a piece of skin on it that turned grey and it came right off. And i was looking in the mirror at my tongue and it was about as round as my little finger and it was deep.  And they told me to gargle with that water and peroxide after a couple of days it started to go away.  I stopped doing it for a couple of days and then it started coming back. So i did it again and made sure i did it right and it went away. I found that my short term memory was really bad and i couldn't remember what in front of me. I even forgot my doctor where he was located and what he looked liked. I looked at his card and knew it was my doctor but couldn't remember anything else, I had to go to the store and had them look up his address and gave me directions to the doctor and i went down there but it was a Saturday and it wasn't open. I did sleep for more than 3 days and told me he couldn't given me anything because of the medications I am on. But i told him i need something now i haven't slept, something is wrong. He did end up getting me a prescription for Quietin or something like that and i had to take 2. I tried to take one but i hated how it made me feel. Then all around my eyes went black and they stay black now and it looks someone punched me in both eyes.  The top of my head was bothering me and it wasnt like a headache but it hurt. And thats when i had to go get some aspirin.  My tendons in my fingers began to hurt and they felt tight and they would sting when i would try and move my fingers. I have trouble in conversation to find the words i need to speak. My right ear feels like its infected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: I woke up and showered the morning after vaccine.  My arm was understandably sore as expected.  When I got out of shower and put deodorant on, I recognized that my whole arm pit, extending down and toward left breast, felt like a bruise, and it was overly sore to apply deodorant.    I think it's lymph node involvement?   I took some naproxen and also drinking lots of water to try to flush my system.  Today, 2 days after injection,  I'm still sore but not as bad.   i'm not sure if this is considered "recovered"- being less sore.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MENB, MNQ
Symptoms: Injection site bruising, Injection site induration, Irritability, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: PT RECEIVED MCV AND MBB PRIOR TO RECOMMENDED AGE IN THE LEFT DELTOID IN ERROR. PT ALSO RECEIVED DTAP AND HEP A IN LEFT THIGH VASTUS LATERALUS APPROPRIATE FOR AGE ON 05/13/2025. NO SYMPTOMS AT TIME OF VISIT. PHONE CALL F/U THE NEXT DAY UNABLE TO REACH BY PHONE.  PT'S MOTHER CALLS TODAY 06/09/25 TO REPORTS BRUISING AND HARD KNOT TYPE SWOLLEN AREA TO RIGHT THIGH THAT DEVELOPED 2-3 DAYS POST VACCINATION. RAN FEVER 1 DAY AFTER VACCINATION. REPORTS CHILD HAS BEEN FUSSIER SINCE VACCINATIONS AND THE KNOT HAS GOTTEN SMALLER BUT IS STILL ABLE TO BE FELT.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Diarrhoea, Feeling abnormal, Headache, Nausea, Pain in extremity
Clinical narrative: patient stated he had leg pain then head pain and then felt fuzzy he turned white in color felt nausea and had diarrhea within 10 minutes of vaccines
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pallor
Clinical narrative: patient stated he had leg pain then head pain and then felt fuzzy he turned white in color felt nausea and had diarrhea within 10 minutes of vaccines
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Client provided vaccine history showing last MMR injection in 04/25 and no recent live virus immuniz.  Client stated on Part B form, no vaccines received in past 4 wks.  After client left and I was charting, I saw a varicella vaccine had been given 05/22/25,  becoming invalid since I administered MMR.   Client had no reactions to any vaccines including MMR received.  Varicella vaccine is considered invalid since another live vaccine (MMR on 06/05/25) was given prior to 28 days from varicella vaccine (05/22/25).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Per patient, an hour after she left the pharmacy her right arm developed red rash & it became sore that got bigger over the weekend. I informed the patient to take an antihistamine & apply Benadryl cream and she informed me now rash is getting better.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Malaise
Clinical narrative: MALAISE, ELEVATED BLOOD PRESSURE
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported her left arm ( injection site) started swelling, warm to touch and painful  two days after the shot. Patient uses ice pack, ibuprofen and/or tylenol, benadyl  after counseled to the pharmacist
Age: 11.0
Sex: M
Vaccine: PNC20
Symptoms: Unevaluable event
Clinical narrative: none
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Condition aggravated, Eczema, Erythema, Pyrexia, Rhinorrhoea
Clinical narrative: Had fever to 103 about 4.5 hours after receiving vaccine and runny nose,  and then facial redness and swelling that lasted 4 hours and then had flare up of eczema for 1 day.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Swelling face
Clinical narrative: Had fever to 103 about 4.5 hours after receiving vaccine and runny nose,  and then facial redness and swelling that lasted 4 hours and then had flare up of eczema for 1 day.
Vaccine: PNC13
Symptoms: Antibody test abnormal, Illness
Clinical narrative: repeated illnesses; This is a spontaneous report received from a Nurse from medical information team.  A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "repeated illnesses".  Additional information: Pediatric patient received 4 doses of PCV13. Had visit with immunologist after repeated illnesses and received report pneumococcal titers were low. Patients insurance will not cover PCV23. Given this specific situation, is there any data that supports patient use of PCV20.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: prescribed Paxlovid; prescribed Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "prescribed Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: During an inbound call the patient, (name withheld), stated, "I was prescribed Paxlovid and in the past when I've taken it, I've never paid anything." Later, she said, "the only medication that I do out of Pfizer is just this COVID medication, Paxlovid and the other Pfizer thing is, when I get vaccinated I I only do the Pfizer vaccine, that's it." Towards the end of the call she states, "It's very frustrating cause I feel sick right now and I really don't want to be going through this but it's terrible."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019548 (BioNTech SE), 2024SA035670 (SANOFI).  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since Oct2023) at 600 mg (600 mg, once) and second regimen since Oct2023 (ongoing)) at 300 mg (300 mg, every other week), all subcutaneous for eczema, urticaria. The patient's relevant medical history was not reported. Concomitant medication(s) included: XOLAIR (ongoing). The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". The action taken for dupilumab was dosage not changed.  Additional information: This case involves a patient who developing fever about 2.5 days after covid injection and dupixent for urticaria with no reported adverse event while being treated with dupilumab (Dupixent) with the use of medical device prefilled syringe and covid-19 vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant nedications included OMALIZUMAB (XOLAIR). In October 2023, the patient started treatment with initial loading dose of dupilum ab solution for injection 600 mg once subcutaneous followed by maintenance dose of 300 mg every other week subcutaneous (with an unknown batch number and expiration date) for Eczema and Urticaria(product use in unapproved indication) (latency: same day). Information regarding batch number and expiration date were requested. On an unknown date, patient stared treatment with covid-19 vaccine injection (with an unknown strength, dose, route, frequency, batch number and expiration date) for Prophylactic vaccination On an unknown date the patient developed a non-serious event "developing fever about 2.5 days after covid injection" (pyrexia) (unknown latency). It was reported "patient reported current xolair and dupixent therapy, patient reports xolair therapy was being slowly weaned off and will continue with dupixent therapy, dupixent therapy started beginning of oct-2023 with samples from md office, unknown xolair therapy start date or estimated end date, currently taking xolair every 6 weeks, unknown xolair dose, no new or worsening eczema symptoms reported by patient, patient reported feeling more energy and "younger", unknown if prescribing md was same for both medications, unknown if md (Doctor of medicine) aware. patient reported received covid injection afte: start of dupixent therapy, palient reported developing fever about 2.5 days after covid injection, unknown date, patient reports no missed doses, md aware, md recommends a slower wean off of xolair." DUPILUMAB (DUPIXENT) was continued for dupilumab and Not applicable for covid-19 vaccine. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown   Batch/lot number is not provided, and it cannot be obtained.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Biopsy skin abnormal, Eczema, Pruritus, Rash, Skin burning sensation
Clinical narrative: itching; Chronic burning eczema rash all over body; Chronic burning eczema rash all over body; Initial information received on 01-Jun-2025 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves a 43-year-old male patient who had chronic burning eczema rash all over body and itching after receiving Diphtheria-2/Tetanus/5 AC pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Prednisone; and Tacrolimus for Rash and Pruritus.  On 12-Jul-2022, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis Vaccine Suspension for injection (lot number, strength and expiry date-unknown) via subdermal route in unknown administration site for Tetanus.  Information on the batch number was requested corresponding to the one at time of event occurrence.  On 01-Se-2024 the patient developed chronic burning eczema rash all over body (skin burning sensation), chronic burning eczema rash all over body (eczema) 2 years 1 month 20 days).  On an unknown date the patient developed itching (pruritus) (unknown latency).  Relevant laboratory test results included: Biopsy skin - On an unknown date:  [Lab test (biopsy) on skin condition came back positive for chronic excema]  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.  Seriousness Criteria- Skin burning sensation and eczema was leading to disability.; Sender's Comments: Sanofi company comment dated 04-JUN-2025: This case involves a 43-year-old male patient who had chronic burning eczema rash all over body and itching after receiving Diphtheria-2/Tetanus/5 AC pertussis Vaccine [Adacel]. Further information regarding regarding allergic history, medical history, and tolerance,  laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered of expired ACT-HIB with no reported Adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 3 years and 6 months old female patient who administered expired  HIB (PRP/T) vaccine [ACT-HIB] 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 3-component, tetanus vaccine toxoid (Infanrix) and pneumococcal vaccine conj 13 V (CRM 197) (Prevnar 13) both for prophylactic vaccination (Immunisation).  On 16-Mar-2023, the patient received a dose of 0.5 ml of expired suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot UJ614AB and expiry date 12-Mar-2023) (strength : standard and frequency: once) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (Latency: same day).  Reportedly, Nurse reported that patients were administered expired two years ago.   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.
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administering ACTHIB that was not reconstituted with the packaged diluent and instead used sterile water with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] that was not reconstituted with the packaged diluent and instead used sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (unknown strength) with lot UK169AB and expiry date 20-Feb-2026 via unknown route in unknown administration site for Immunization that was not reconstituted with the packaged diluent and instead used sterile water 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: 35.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: 35-year-old patient was supposed to receive ADACEL but instead was administered DAPTACEL in error with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 35 years old female patient who was supposed to receive diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] but instead was administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] in error 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 hepatitis B vaccine (HEP B VAX) for Immunisation.  On 04-Jun-2025, 35 years old patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (lot 3CA25C1, expiry date Apr-2026, frequency: once and strength: standard) via intramuscular route in unknown administration site in error and was supposed to receive diphtheria-15/tetanus/5 AC pertussis vaccine (formulation Suspension for injection) with no reported adverse event (wrong product administered) (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: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue
Clinical narrative: Donor felt dizzy and tired 3 hours after vaccine
Age: 52.0
Sex: F
Vaccine: HEPAB, PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT EXPERIENCED RED, WARM, PAINFUL, SWOLLEN LEFT ARM ABOVE THE ELBOW STARTING 2 DAYS AFTER INJECTION. SHE HAS BEEN EXPERIENCING THE SYMPTOMS 5 DAYS LATER AND WENT TO HER PHYSICIAN. THE PRESCRIBER TOLD HER TO TAKE DOXYCYCLINE 100MG FOR 10 DAYS.
Age: 18.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: syncope episode, brief LOC. last 1-2 mins, nausea.   improved with laying supine with legs elevated.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Swelling
Clinical narrative: PT HAD REDNESS AND SWELLING POST VACCINATION.  SHE HAS TAKEN BENADRYL TO MINIMIZE DISCOMFORT.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Leg amputation, Thrombosis
Clinical narrative: Blood clots, loss of right limb, above knee amputation.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Dizziness, Ear pain, Nausea, Pyrexia
Clinical narrative: Patient reports nausea, arthralgia, fever, otalgia, chest congestion, intermittent dizziness, postnasal drip, vomiting (once) since receiving chikungunya vaccination. She took her emgality injection at the time of symptom onset and is unsure if this exacerbated symptoms. She is also unsure if she has a viral illness as she was recently on vacation, although no known sick contacts. No vaccination site reaction. Treated with supportive measures, zofran, flonase, adequate hydration. Motrin/tylenol as needed.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Respiratory tract congestion, Upper-airway cough syndrome, Vomiting
Clinical narrative: Patient reports nausea, arthralgia, fever, otalgia, chest congestion, intermittent dizziness, postnasal drip, vomiting (once) since receiving chikungunya vaccination. She took her emgality injection at the time of symptom onset and is unsure if this exacerbated symptoms. She is also unsure if she has a viral illness as she was recently on vacation, although no known sick contacts. No vaccination site reaction. Treated with supportive measures, zofran, flonase, adequate hydration. Motrin/tylenol as needed.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Crying
Clinical narrative: crying inconsolably for several hours, no fever
Age: 64.0
Sex: M
Vaccine: MMR, PNC21, TDAP, VARZOS
Symptoms: Arthropod bite, Product preparation issue, Rash erythematous, Rash pruritic
Clinical narrative: MMR II vaccine was incorrectly reconstituted with a syringe of Moderna Spikevax covid vaccine. Patient returned to pharmacy 2 days later with itchy red rash. He had gone to the ER and was prescribed prednisone with a diagnosis of severe reaction to flea bites. It is unknown if this rash was related to vaccinations, but reporting just in case.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: I received the Prevnar 20 vaccine on April 30, 2025. The following day my arm began to be red and itchy around the injection site. The redness area and itchiness increased for 5 days, then began to subside. It was at its largest on May 5, and measured approximately 5 inches in length and 3 inches in width on that day and itched a lot. The reaction slowly subsided over the following week and was completely gone by two weeks.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Blood glucose increased, Type 1 diabetes mellitus
Clinical narrative: Type 1 diabetes diagnosis after ER visit found blood sugar over 500 roughly 20 hours after receiving first dose.  Hashimotos diagnosis 1 month after
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Pain in extremity, Streptococcus test
Clinical narrative: Rt. arm soveness croupy cough
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: PATIENT COMPLAINED OF A VERY SORE ARM. SHE FELT THAT THE VACCINE ADMINISTRATION HIT A BONE. SHE COULDN'T LIFT HER ARM AND WAS IN PAIN SO WENT TO URGENT CARE. THEY THOUGHT IT HIT A NERVE. SHE WENT TO EMERGENCY AND THEY COULDN'T HELP HER. TOLD HER TO REST. IN 2 WEEKS SHE FELT BETTER.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site indentation, Myalgia, Vitiligo
Clinical narrative: I?ve been getting Covid shots since they started.  My 2nd and 3rd shots gave me Covid arm in my left arm.  I switched to right arm and was fine until now.  I noticed the last week in May that I now have an indentation and vitiligo where I have been given the shot on my right arm.  I also have the feeling of pain (joint and muscle) in same arm.
Vaccine: MMR, MMR
Symptoms: Device issue, No adverse event
Clinical narrative: No adverse event; HCP reported PQC for 3 Sterile Diluent PFS that all occurred during one vaccination visit:    Event #1: HCP reports after she diluted MMR II with sterile Diluent PFS.  Upon withdrawing the MMR II vaccine back into the PFS- the Barrel of the Sterile D; Syringe issue; Complication of device removal; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 20-MAY-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) 0.5 ml (lot #X028353, who had been verified to be a valid lot number, expiration date: 11-DEC-2025) administered by Intramuscular route as prophylaxis; sterile diluent (lot #1973244, who had been verified to be a valid lot number, expiration date: 01-MAR-2026). It was reported that the health care professional was administering Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) and the needle and leurlock separated from the barrel of the prefilled syringe (PFS). The needle and leurlock remained in the patient and the PFS separated from the leurlock (Poor quality device used, Syringe issue, Complication of device removal).  In addition some information about syringe was reported as: health care professional reported after she diluted Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) with sterile Diluent PFS. Upon withdrawing the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) vaccine back into the PFS- the Barrel of the Sterile Diluent separated from the Needle and Leurlock- The Needle and Leurlock remained in the stopper of the vial and the barrel of the PFS was separate. The caller states all components were intact (Not broken) but were just separated.   Also, after Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) (not related to #1 or #2 report) was administered. HCP went to engage the safety cap on the needle and the needle and leurlock "Flew across the room". HCP states no injuries from this incident. HCP confirmed there were no broken components- The leurlock and needle separated from the barrel of the PFS.   No additional adverse events.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: ipol  was administered after temperature excursion with maximum/lowest temperature reached: 28.6 fahrenheit duration 1 hour and 13 minutes with no reported adverse event; Initial information received on 06-Jun-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 received IPV (VERO) [IPOL] after temperature excursion with maximum/lowest temperature reached: 28.6 Fahrenheit duration 1 hour and 13 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown  dose of suspect IPV (VERO), Suspension for injection, lot W1C751M, expiry date:18-nov-2025,strength not reported via unknown route in unknown administration site for Prophylactic vaccination (immunization) post excursion where maximum/lowest temperature reached: 28.6 Fahrenheit duration 1 hour and 13 minutes with no reported adverse event (poor quality product administered) (unknown latency).  Reportedly, human error was not involved; Reason: Unknown. The extended stability data doesn't cover the excursion and product has been administered post excursion.  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: 32.0
Vaccine: TDAP
Symptoms: Off label use
Clinical narrative: Intentional Off Label Prescription by HCP: Adacel is prescribed with off label diagnosis code S31.31XA Laceration without foreignbody of scrotum and testes, initial encounter with no reported adverse event; Initial information received on 03-Jun-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 32 years old and unknown gender patient for whom diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] intentional off label prescription by hcp with off label diagnosis code s31.31xa laceration without foreign body of scrotum and testes, initial encounter with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose (0.5ml) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine; Suspension for injection in pre-filled syringe (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for Laceration without foreign body of scrotum and testes, initial encounter (Scrotal injury) and (Testicular injury); intentional off label prescription by hcp with off label diagnosis code s31.31xa laceration without foreign body of scrotum and testes, initial encounter with no reported adverse event (off label use). (latency: same day)  Information on the batch number cannot be requested corresponding to the one at time of event occurrence.  Action taken was not applicable.
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No symptoms reported.; Nurse called and reported that 1 dose of GARDASIL 9 was inadvertently administered to a 68 year old patient when the patient actually should have received PCV 20. Caller stated this patient had never had any previous HPV vaccinations. Caller stated n; This spontaneous report was received from a nurse and refers to a 68-year-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. The patient had never had any previous human papillomavirus (HPV) vaccinations.  On 16-MAY-2025, the patient was inadvertently vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) suspension for injection at a dose of 1 dosage form (1 dose) (route of administration, anatomical location, lot # and expiration date were not reported) instead of pneumococcal vaccine conj 20v (crm197); the vaccine should have been administered for prophylaxis (Wrong product administered). No patient symptoms had been reported (No adverse event).  Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC reported; HCP reported that a husband and wife both received the VARIVAX and PROQUAD vaccines concomitantly; HCP reported that both patients are adults; This spontaneous report was received from a medical assistant and refers to an adult female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 20-May-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), lot #Y015108, expiration date: 06-Sep-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On 20-May-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y003883, expiration date: 05-Aug-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age, overdose). No additional adverse event reported (no adverse event).
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC reported; HCP reported that a husband and wife both received the VARIVAX and PROQUAD vaccines concomitantly; HCP reported that both patients are adults; This spontaneous report was received from a medical assistant and refers to an adult male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 20-May-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), lot #Y015108, expiration date: 06-Sep-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.  On 20-May-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y003883, expiration date: 05-Aug-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (product administered to patient of inappropriate age, overdose). No additional adverse event reported (no adverse event).
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC; administration of GARDASIL-9 to a patient under 9 years old; This spontaneous report was received from a nurse and refers to a 6-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 04-JUN-2025, the patient was administered a dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) lot # Y015599 established as valid, expiration date 10-FEB-2027 (dose, route of administration, anatomical location, indication were not provided) (Product administered to patient of inappropriate age). No adverse events were reported.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Underdose, Wrong product administered
Clinical narrative: A FBE called on behalf of an HCP to report an AE for VAQTA in which a 0.5mL pediatric dose administered to an adult patient on an unknown date who should have instead received a 1mL dose. The FBE stated the patient did not experience any other advers; the patient did not experienced any other adverse issues or side effects; This spontaneous report was received from a nurse and refers to a 20-year-old female patient. 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 a dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis; but the patient was administered 0.5 mL (which is the pediatric dose) instead of 1 mL (incorrect dose administered). The patient did not experience any other adverse issue or side effect from the dose administered.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Additional AE/ No PQC; Caller states third dose administered was verified to be VAQTA and was noticed to be expired after  administered to patient.; This spontaneous report was received from a medical assistant and refers to a(n) 9-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Historical drugs included Hepatitis A vaccine (unknown brand name) (lot # NB759), and Hepatitis A vaccine (unknown brand name) (lot # 77DFK). These vaccines were administered at inappropriate schedule, reported as: patient received two hepatitis A vaccines (unknown brand name) at another facility 5 months apart instead of 6 months as recommended. Concomitant therapies were not reported.   On 06-Jun-2025, the patient with the third dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot #Y006121, expiration date: 17-May-2025, 0.5 mL administered by intramuscular route for the treatment of vaccination (expired vaccine used). No additional adverse event reported (no adverse event).
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/No PQC.; HCP calling to report expired administration of RECOMBIVAX HB on 06/02/2025. The product was expired on 05/21/2025 with no TEs. No symptoms reported on behalf of patient. Supported outcome delivered verbally per memo. Received consent to contact. No; This spontaneous report was received from a physician and refers to a 10-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-JUN-2025, the patient was vaccinated with an expired vaccine of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (valid lot number W025817, expiration date: 21-MAY-2025) for prophylaxis (dose, dose number, frequency, anatomical location and route of administration were not provided) (expired product administration), no temperature excursion were reported. No symptoms reported on behalf of patient.   No additional adverse event (AE) reported.
Vaccine: COVID19, FLUN3
Symptoms: Death
Clinical narrative: Patient is deceased; A solicited report has been received from a other health professional in Patient Support Program. The report concerns a male elderly patient born in 1936 (age 88 years).  No medical history was reported.   No concomitant products were reported.   The patient started treatment with Dapagliflozin (dapagliflozin) (batch number(s) Unknown), on an unknown date for product used for unknown indication.      It is unknown if any action was taken with Covid-19 Vaccine (covid-19 vaccine) and Fluenz (influenza vaccine live reassort 3v).   The patient died (preferred term: Death) on 22-FEB-2025.   The patient died on 22-FEB-2025. It is not known whether an autopsy was performed. The cause of death was unknown.   The event was considered serious (Medically Significant and Death).  The reporter did not assess causality for patient is deceased.The reporter did not consider that there was a reasonable possibility of a causal relationship between Dapagliflozin and the following event(s): patient is deceased.  The company physician did not consider that there was a reasonable possibility of a causal relationship between Dapagliflozin and the following event(s): patient is deceased.  The company physician considered that there was a reasonable possibility of a causal relationship between Covid-19 Vaccine and the following event(s): patient is deceased.  The company physician considered that there was a reasonable possibility of a causal relationship between Fluenz and the following event(s): patient is deceased.  Significant  correction on 30-Apr-2025 : coding for the suspect drug influenza has been updated  narrative amended,; Sender's Comments: This is a case report of an 88-year-old male patient with reported fatal outcome (Preferred term: Death) in association with covid 19. Cause of death was further not specified. Advanced age could be possibly confounding. Due to limited information on cause of death, circumstances leading to fatal outcome, indication, autopsy details, medical history, concurrent diseases, concomitant medications, etiological and diagnostic workup, other risk factors; the evaluation did not find evidence to exclude a causal relationship between fatal outcome and suspect; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: Lymphadenopathy worsened; swelling in his neck; swelling in his right arm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of lymphadenopathy in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 92NN2, expiry date 30-MAR-2027) for prophylaxis.   On 28-MAY-2025, the patient received the 1st dose of Shingrix (right arm). On 01-JUN-2025, 4 days after receiving Shingrix, the patient experienced lymphadenopathy (Verbatim: Lymphadenopathy worsened), neck swelling (Verbatim: swelling in his neck) and swelling arm (Verbatim: swelling in his right arm). The patient was treated with clindamycin. The outcome of the lymphadenopathy, neck swelling and swelling arm were resolving.   The reporter considered the lymphadenopathy, neck swelling and swelling arm to be related to Shingrix.     The company considered the lymphadenopathy, neck swelling and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2025 The reporter stated that the patient who received Shingrix and noticed swelling in his right arm and neck on 1st June upon awakening and went to the ER (emergency room). Emergency room attributed to Shingrix. Lymphadenopathy was reported as worsened, and it was not serious. Given 5 day course clindamycin to the patient in emergency room, on 3rd June (on the day of reporting) patient was seen by PCP (primary care physician). Patient reported symptoms were improving. No other products were received by the patient.
Vaccine: RSV
Symptoms: Rash macular
Clinical narrative: Blotchy rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blotchy rash in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced blotchy rash (Verbatim: Blotchy rash). The outcome of the blotchy rash was not reported.   It was unknown if the reporter considered the blotchy rash to be related to Arexvy.     It was unknown if the company considered the blotchy rash to be related to Arexvy.   Additional Information: GSK receipt date: 03-JUN-2025 The patient reported that glad I received it relief, that I was protected, and had minimum symptoms. Mainly, blotchy rash.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient had covid twice; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had covid twice) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient had covid twice). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient had covid twice) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication information was not provided.  It was reported that the first-time patient had Covid was 3 years ago. The patient was going to die literally even though being tough. The patient was prescribed Paxlovid. The reporter swore to God, that the next day, the reporter did not have Covid. It was like a miracle for the reporter. In the second time of developing Covid when the patient had Paxlovid, it did not work at all. He thought they might have changed the formulation, as it was made somewhere else, or might be he did not take it soon enough. However, he did not know the answer to this. Patient did not have the Pfizer vaccine.  Patient waited until day 6 of having Covid, and just thought he had a cold. Patient was more symptomatic with covid that second time. A nurse practitioner prescribed Paxlovid. Patient took the Paxlovid every day and just got sicker and sicker. Patient thought COVID just had to run its course.  Patient stated it was disappointing when he got the vaccine and still got Covid for 2-3 times. Everyone in his family had it for 2-3 times.   This case was linked to US-MODERNATX, INC.-MOD-2025-787143, US-MODERNATX, INC.-MOD-2025-787169, US-MODERNATX, INC.-MOD-2025-787170 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2025: Live follow up received that contains non-significant information, reference number added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787143:same reporter different patient (Caller's family members) US-MODERNATX, INC.-MOD-2025-787170:same reporter different patient (Caller's oldest brother) US-MODERNATX, INC.-MOD-2025-787169:same reporter different patient (Caller's wife)