chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Blindness, Immediate post-injection reaction, Seizure
Clinical narrative: This nurse provided HPV vaccine to R deltoid.  While needle was still in arm patient reports he can't see and began to convulse and slide out of chair.  This nurse took needle out of arm and placed it on side table and  assisted patient by supporting his head and lowering him to the ground.  This lasted approximately 20 seconds.  Mother was present in the room and hollered for assistance.  RN came to room as patient was coming to.  RN went to retrieve pulse oximeter.  This nurse assisted patient to room next door to lay down and turned the fan on.  Checked vital signs:  BP:127/79, P:80, O2: 97%, and R: 22.  Patient was able to sit up and drink some water.  Patient continued to lay on bed and sip water for 15 minutes.  Father arrived and all questions were answered.  Encouraged parents to follow up with PCP and mother voices she is taking patient to ER.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Staff member administered MenQuadFi dose # 2 too early per database and vaccine guidelines. No treatment needed or significant outcome for patient.
Vaccine: RAB
Symptoms: Hallucination
Clinical narrative: Donor states having hallucinations after leaving center from receiving rabies vaccine. Vaccine was given at 1345, waited 20 minutes for any reaction. Donor then left center, as he walked to a close by store to buy groceries, he felt hallucinations as if someone was following him.
Age: 11.0
Sex: F
Vaccine: HEP, HPV9, IPV, MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: On 06/20/2025 an 11 year old child in clinic for vaccinations, syncopal episode occurred resulting in patient taken to ER (Emergency Room) by Emergency Medical Services (EMS).   Patient very nervous, shaking, and anxious about receiving vaccines. Patient received the following vaccines, Hep B, Polio, Varicella, HPV, meningococcal, and Tdap. A few minutes after receiving the vaccines, patient slumped in the chair, became pale in color, and  patient was laid down. Patient started to respond to name and oriented x 3. Parent explained child hasn?t eaten any food  since breakfast earlier today.   1:36 PM HR70, SAT 98% BP 98/60- 911 called, glucagon given. 1:40 PM HR 96, SAT 98%, BP 101/70 Patient responding to verbal commands, oriented x3, alert.  1:44 PM HR 109, SAT 97%, BP 92/60 Patient complained of nausea, no vomiting.  1:47 PM EMS arrival to site 1:49 PM HR 109, SAT 97%, BP 102/70, BS 102. Patient accompanied by her mother was taken to ER by EMS.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Feeling hot
Clinical narrative: Patient started feeling lightheaded and hot about 5 minutes after the vaccination. It could have been related to her being nervous about getting the vaccine. Patient was fanned to cool down and offered cold water to drink. She did not start feeling better within 5 minutes and she requested we contact 911. Her blood pressure was taken and it was 126/74 with a pulse of 79. Patient was then taken by paramedics within 15 minutes after vaccine was given.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event, Wrong patient received product
Clinical narrative: Vaccine for a sibling sitting on the counter next to the patient's vaccine. Two nurses vaccinating patient. Nurse #2 gave the sibling's vaccine to the patient, instead of Gardasil. Patient received 2 doses of pediatric Havrix on the same day. No signs/symptoms of any problems occurred.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Dizziness, Fatigue, Swelling
Clinical narrative: They kept keep pushing into getting the vaccine, i went in with abdominal pain. They told me i needed right away, And i am feeling very tired and i am very upset. I am getting lightheaded, I am having some type of swelling.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Micturition urgency, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: After second dose of shingrix, patient reported that she was having burning and urging sensation to go to the bathroom and ended up wetting herself. Also, she came down with a cold and was congested. Biggest compliant was about the bladder issues and unable to hold in her urine.  Patient was advised to see a doctor / urgent care. She did not report back to the pharmacy if she did so.
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Body temperature increased, Chills, Headache, Influenza like illness, Malaise
Clinical narrative: About 4 hours after I started feeling unwell. Quickly I began shivering slightly.   Temp was 98.4 then shivering starting to involve whole body to point of pain and couldn't hold anything in hands. Temp then went from 99.4 to 102.8 in half hour.  I took motrin and hot shower to try and stop shaking. Then used an electric blanket.  Felt flu like for about 24 hours with headache.  .
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Erythema, Malaise, Mobility decreased, Pain in extremity
Clinical narrative: Initially injection hurt a lot going in Right arm.  Then later in the day I began to feel very dizzy, felt overall horrible, log grade fever, arm soreness getting progressively worse, couldn't sleep due to pain, second day better, arm very sore.  Limited use.  Later second day, same reaction, dizziness, arm redness and rash spreading down my arm.  Feverish, and overall unwell feeling.  The next five days no other symptoms except redness and rash getting larger.  Finally called my PCP, she ordered cream and antibiotic just in case since I was out of town.  Used cream and within three days, if was finally gone.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Rash, Sleep disorder
Clinical narrative: Initially injection hurt a lot going in Right arm.  Then later in the day I began to feel very dizzy, felt overall horrible, log grade fever, arm soreness getting progressively worse, couldn't sleep due to pain, second day better, arm very sore.  Limited use.  Later second day, same reaction, dizziness, arm redness and rash spreading down my arm.  Feverish, and overall unwell feeling.  The next five days no other symptoms except redness and rash getting larger.  Finally called my PCP, she ordered cream and antibiotic just in case since I was out of town.  Used cream and within three days, if was finally gone.
Age: 63.0
Sex: F
Vaccine: CHIK
Symptoms: Erythema, Skin warm
Clinical narrative: Left shoulder with erythema and warmth. MD prescribed cephalexin (10 day course) and cetirizine.
Age: 8.0
Sex: M
Vaccine: MNQ, RAB
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: First simultaneous itching at both vaccine injection sites then Hives at both upper arm injection sites that included the back shoulders; immediately gave 5ml of children's Benadryl repeated in 5 minutes with a second dose of 5 ml per child's weight of 59 #. No respiratory involvement. EMS called and assessed Pt. Normal Vital signs. SpO2 94%. No progression of hives. Itching resolved. EMS agreed with treatment plan and discharged Pt. to mother's choice to see PMD. Continued to observe Pt. an hour before discharge to PMD.
Age: 1.67
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 20 month old that received Kinrix; Incorrect vaccine/the patient needed the Dtap/IPV immunization; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-month-old patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   Co-suspect products included DTPa-IPV (DTPa-IPV) for prophylaxis.   On an unknown date, the patient received Kinrix and DTPa-IPV. On an unknown date, an unknown time after receiving Kinrix and not applicable after receiving DTPa-IPV, the patient experienced inappropriate age at vaccine administration (Verbatim: 20 month old that received Kinrix) and wrong vaccine administered (Verbatim: Incorrect vaccine/the patient needed the Dtap/IPV immunization). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 11-JUN-2025 The nurse reported that they had a 20-month-old patient that received Kinrix which led to inappropriate age at vaccine administration, and he/she was asked to follow-up if there is any concern or anything that need to be done. When asked what vaccine was supposed to receive, the nurse answered that the patient needed the Dtap/IPV immunization for the patient's age which led to wrong vaccine administered.
Age: 67.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Tremor
Clinical narrative: Per RN, pt had  Bexsero 3rd dose, left office, returned and about 3 hrs later to ambulatory suite and had severe shills and shaking for approximately 45 mins.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix possible powder administration with another diluent than the one provided; Shingrix possible powder administration with another diluent than the one provided; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a elderly male patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2027) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Shingrix possible powder administration with another diluent than the one provided) and inappropriate preparation of medication (Verbatim: Shingrix possible powder administration with another diluent than the one provided). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable.   Additional Information: GSK Receipt Date: 13-JUN-2025 and 14-JUN-2025 Practice manager wanted to know how to proceed after finding a Shingrix box 2 with an odd number of vials only including the diluent, so she was supposing that the powder was administered to a patient using another diluent (saline water) than the one provided which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. Also, mentioned that she still needed to find out who was the patient that received it. Recommendation was given about contacting the medical information team again if she finds out the patient involved and date of administration.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-month-old male patient who received HAV (Havrix) (batch number BR2GD, expiry date 16-MAY-2025) for prophylaxis.   On 13-JUN-2025, the patient received the 1st dose of Havrix. On 13-JUN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was 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: 13-JUN-2025 The healthcare professional called in to report that they accidentally administered two doses of expired Havrix to two patients which led to, expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-month-old male patient who received HAV (Havrix) (batch number BR2GD, expiry date 16-MAY-2025) for prophylaxis.   On 13-JUN-2025, the patient received Havrix. On 13-JUN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was 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: 13-JUN-2025 A healthcare professional called in to report that they accidentally administered 2 doses of expired Havrix to 2 patients, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2025074252, reported by the same reporter for a different patient.; Sender's Comments:  US-GSK-US2025074252:same reporter /different patient
Vaccine: HIBV
Symptoms: Intercepted product preparation error, Product preparation error
Clinical narrative: Hiberix - Incorrect vaccine preparation/used the diluent of Priorix for the Hiberix vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of intercepted product preparation error in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient did not receive Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced intercepted product preparation error (Verbatim: Hiberix - Incorrect vaccine preparation/used the diluent of Priorix for the Hiberix vaccine). The outcome of the intercepted product preparation error was not applicable.   Additional Information: GSK receipt date: 13-JUN-2025 A nurse mentioned they used the diluent of Priorix for the Hiberix vaccine, and the reporter confirmed that the dose was not administered, which led to intercepted product preparation error. The reporter asked if the diluents were the same or if they were different. No further details were provided by the reporter.
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site reaction, Rash erythematous
Clinical narrative: red rash at site of injection/likely celulitis; red rash at site of injection/likely celulitis; This is a spontaneous report received from a Physician.  A 67-year-old female patient (not pregnant) received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 12Jun2025 as dose number unknown, single (Lot number: LP4947) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Hypersensitivity"; Bactrim, reaction(s): "Hypersensitivity"; Tetracycline, reaction(s): "Hypersensitivity". The following information was reported: VACCINATION SITE CELLULITIS (non-serious), VACCINATION SITE RASH (non-serious) all with onset 13Jun2025, outcome "unknown" and all described as "red rash at site of injection/likely celulitis". Therapeutic measures were taken as a result of vaccination site cellulitis, vaccination site rash.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. The patient taking any other medications within 2 weeks of the event starting. Treatment received for the adverse event included antibiotic.  Causality for "red rash at site of injection/likely celulitis" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Diarrhoea, Nausea, Pain, Vomiting
Clinical narrative: Severe vomiting; diarrhoea; Nausea; Chills; Body ache; This is a spontaneous report received from a Consumer or other non HCP.  A 30-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Jun2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025), described as "Body ache"; CHILLS (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025); NAUSEA (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025); VOMITING (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025), described as "Severe vomiting"; DIARRHOEA (hospitalization) with onset 06Jun2025 at 10:00, outcome "recovered" (10Jun2025). The patient was hospitalized for vomiting, diarrhoea, nausea, chills, pain (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of vomiting, diarrhoea, nausea, chills, pain. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Vaccine: PNC20
Symptoms: Parotitis
Clinical narrative: parotitis/My parotid gland on the left-hand side is swollen; This is a spontaneous report received from a Pharmacist.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 19Jun2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAROTITIS (non-serious) with onset 20Jun2025, outcome "unknown", described as "parotitis/My parotid gland on the left-hand side is swollen".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Neurodermatitis
Clinical narrative: prurigo nodularis developed after the covid vaccine; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA153013 (Sanofi).  A 62-year-old female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since 12Dec2022 (Lot number: 4F595A, Expiration Date: 30Nov2026) at 300 mg (300 mg qow), subcutaneous for dermatitis atopic. The patient's relevant medical history included: "atopic dermatitis" (ongoing). Concomitant medication(s) included: CALCIPOTRIENE; SULFACETAMIDE SODIUM AND SULFUR [SULFACETAMIDE SODIUM;SULFUR]; NALTREXONE HCL. The following information was reported: NEURODERMATITIS (non-serious), outcome "unknown", described as "prurigo nodularis developed after the covid vaccine". The action taken for dupilumab was unknown.  Additional information: It was reported patient said that when she was taking dupixent she formed abscesses more than once and the medication was not working. Patient had been started on nemluvio therapy. patient stated prurigo nodularis developed after the covid vaccine. no other details were provided'. An unknown (nemluvio therapy) corrective treatment was received for abscess and not reported for neurodermatitis."  Batch/lot number is not provided, and it cannot be obtained.  BNT162B2 OMICRON (KP.2) is under agreement with BIONTECH SE.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: PENTACEL was administered without the ActHib portion with no reported adverse event; Initial information received on 20-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who received diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without the ACT-HIB portion 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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20); and Rotavirus vaccine live oral 1v (Rotarix) as both for Immunisation.  On 16-Jun-2025, the patient received 0.5 ml of diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with strength- standard (expiry date- 30-SEP-2025 and lot K1098A) once via unknown route in unknown administration site for Immunization, without the ACT-HIB portion with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Caller inquiring if the DTaP-IPV portion would be valid and then if the Act-Hib portion could be administered separately.  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: 12.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: medical assistants accidentally administered daptacel to a 12-year-old patient with no reported adverse event; Initial information received on 20-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient who was accidentally administered with Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] by medical assistant  to a 12-year-old 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 HPV vaccine and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) both for Immunisation.  On 20-Jun-2025, the patient received 0.5mL of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot 3CA55C1, expiry date 31-Aug-2026, strength standard and frequency once) via intramuscular route in the left deltoid for Immunisation and was accidentally administered to a 12-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Reportedly, they wanted to know if they need to revaccinate and what they should look out for.  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: 33.0
Sex: M
Vaccine: TD, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to receive adacel, but they received tenivac with no reported adverse event; Initial information received on 20-Jun-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 33 years old male who was supposed to receive diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], but they received diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On 20-JUN-2025 the patient was supposed to receive diphtheria-2/tetanus/5 AC pertussis vaccine, but they received 0.5 of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO preservative adult Suspension for injection of standard strength, frequency once with lot U7927AA and expiry date 13-Oct-2025 via intramuscular route in the left deltoid for Immunization with no reported adverse event (wrong product administered) (latency same day).  Reportedly, The pharmacist explains that the patient's wife is giving birth soon, which is why he needs pertussis coverage. When he was vaccinated, he was expecting pertussis coverage. However, he was erroneously given tenivac; he did not receive adacel.  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: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness and swelling that has progressively gotten worse since the 21st of June...area is warm, red and swollen at an area of 3.5 " x 2.75"
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle spasms
Clinical narrative: Lower leg cramping for 2 days.
Age: 25.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Fall, Hypoacusis, Peripheral coldness, Thirst, Tunnel vision
Clinical narrative: After giving pt the 2 vaccines, we asked the pt to stay for 15 minutes for observations. A few minutes later, heard mom calling out pt's name. Stepped out to see pt (sitting on chair) slowly falling to her left side. Mom was able to catch pt before she hit her head on the floor. So pt never hit her head. Pt was pale, and her hands were cold to the touch. Pt did not have any breathing issues, or anything other extreme symptoms. We asked pt and mom if they needed us to call 911, but they said  not needed. Per mom, while talking to pt, pt asked for water, and then her eyes become unfocused and she started to fall sideway, while sitting.  Per pt, she said she was feeling anxious/emotional prior to getting vaccines, as she always feel anxious prior to getting any vaccines. Pt stated that she felt thirsty, had tunnel vision, and muffled hearing. Upon being pulled up from the floor, pt said she felt like she was asleep, and that she was waking from her sleep.  She knew she was at the pharmacy, and felt embarrassed for what had happened. She kept saying sorry. Upon feeling more alert after a couple of minutes, pt asked for water, and we went and got pt a bottle of cold water. Again, pt refused 911 call. We asked pt and mom to remain in pharmacy area for at least 30 minutes to make sure everything is ok. we checked on pt multiple time and pt was feeling much better, more alert, and had colors back, and hands not as clammy. After 30 minutes, pt and mom left the pharmacy on their own, since pt said she felt better.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Mental status changes
Clinical narrative: Change in condition related to altered mental status and abnormal vital signs. On 6/22/2025 @ 1749, resident noted with BP 136/86, Pulse 102, Temperature 98.6, Oxygen saturation 73% on Room Air, BS 124 mg/dl. Resident noted to have eyes rolling to back of head, unable to hold arms up during assessment, only responded to pain stimulation (Sternal rub), Resident transferred to Hospital for further evaluation.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient got severe hives and itching
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received a 2nd dose of Prevnar 20 on accident. First dose was 4/24/2024 in a different state.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Vomiting projectile
Clinical narrative: Projectile vomited for the first time in her life  about 5-6 hours after vaccine
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Hives around the vaccine site.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: patient presented to the pharmacy 6/18/2025 at 4PM with large raised bump, raised and hot to touch, approximately softball size. reported it at coming on next day after vaccination 6/17/2025 and itchy. Reported taking benadryl and applying ice.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Asthenia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: 103.9 temp x 3 days, fever, chills, nausea, severe muscle aches, shooting pain in right arm to finger tips on day 2, weakness, fatigue, severe arm pain at injection site for 2 days. On day 6, deep red welts and edema appeared on arm,  spreading, itching.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Nausea, Oedema peripheral, Pain, Pruritus, Pyrexia
Clinical narrative: 103.9 temp x 3 days, fever, chills, nausea, severe muscle aches, shooting pain in right arm to finger tips on day 2, weakness, fatigue, severe arm pain at injection site for 2 days. On day 6, deep red welts and edema appeared on arm,  spreading, itching.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Urticaria
Clinical narrative: 103.9 temp x 3 days, fever, chills, nausea, severe muscle aches, shooting pain in right arm to finger tips on day 2, weakness, fatigue, severe arm pain at injection site for 2 days. On day 6, deep red welts and edema appeared on arm,  spreading, itching.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient previously received the Boostrix on 8/17/24, so this is a duplicated vaccine.  The vaccine on 8/17/24 was not reported to FL shots, so the pharmacist was unaware that it was previously given last year.
Age: 0.33
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Presyncope
Clinical narrative: Patient felt dizzy and nearly fainted after receiving the vaccine. Pt's father and Health Professional moved pt from immunization area to another chair. When pt was asked how he felt, pt responded feeling lightheaded, dizzy, about to faint. Pharmacy offered to call 911, but pt's father declined. After sitting on chair for approximately 10 minutes and drinking water, pt reported dizziness was gone, responded no other side effects, he able to walk normally. Pt's father stated afterwards he was likely too nervous getting vaccine.
Sex: M
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event; Paramedic calling to report inadvertent administration of PROQUAD to a 6 month old male. HCP reports that patient was supposed to receive the MMR II vaccine due to outbreak of measles in the area but was accidentally given the PROQUAD instead. PROQUA; Paramedic calling to report inadvertent administration of PROQUAD to a 6 month old male. HCP reports that patient was supposed to receive the MMR II vaccine due to outbreak; This spontaneous report was received from a consumer or other non health professional and refers to a 6-month-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-Jun-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL in Left Thigh (indication, expiration date, and lot # were not reported). On 17-Jun-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient was supposed to received the MMR II vaccine, but was accidentally given the PROQUAD instead (Inappropriate schedule of vaccine administered and wrong vaccine administered). No additional adverse event was reported.
Sex: M
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional adverse event; Paramedic calling to report inadvertent administration of PROQUAD to a 6 month old male. HCP reports that patient was supposed to receive the MMR II vaccine due to outbreak of measles in the area but was accidentally given the PROQUAD instead. PROQUA; Paramedic calling to report inadvertent administration of PROQUAD to a 6 month old male. HCP reports that patient was supposed to receive the MMR II vaccine due to outbreak; This spontaneous report was received from a consumer or other non health professional and refers to a 6-month-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 17-Jun-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 0.5 mL in Left Thigh (indication, expiration date, and lot # were not reported). On 17-Jun-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient was supposed to received the MMR II vaccine, but was accidentally given the PROQUAD instead (Inappropriate schedule of vaccine administered and wrong vaccine administered). No additional adverse event was reported.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Patient previously received a TDAP vaccination on 4/11/2025 and then again on 6/18/2025  Patient was 34 weeks pregnant on 6/18/2025.  She was 28 weeks pregnant on 4/11/2025
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Caller reported AE on behalf of a patient who is currently pregnant (third trimester) and was inadvertently administered GARDASIL 9 instead of TDAP vaccine on 05/29/2025. Caller reported that patient was not administered TDAP. No symptoms reported. N; No symptoms reported.; Caller reported AE on behalf of a patient who is currently pregnant (third trimester) and was inadvertently administered GARDASIL 9 instead of TDAP vaccine on 05/29/2025. Caller reported that patient was not administered TDAP. No symptoms reported. N; This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age.   The patient's medical history, obstetric history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On an unspecified date, the patient became pregnant. On 29-May-2025, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection (lot #Y015179, expiration date: 28-Jan-2027), 0.5mL/dose, as prophylaxis (route of administration were not provided), instead of instead of Diphtheria vaccine toxoid; Pertussis vaccine acellular; Tetanus vaccine toxoid (TDAP) vaccine when she was in her third trimester (Vaccine exposure during pregnancy) (Wrong vaccine administered). However, no symptoms, additional adverse events (AE), nor details were reported.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; nurse calling to report administration of expired MMR-II to a patient on 16-JUN-2025.; This spontaneous report has been received from a nurse referring to a 2-year-old male patient. The patient's concurrent conditions, pertinent medical history, previous drug reactions/allergies, and concomitant therapies were not provided.  On 16-JUN-2025, the patient was vaccinated with Measles and Mumps Virus Vaccine, Live (M-M-R II) with valid lot # X022986 and expiration date 11-JUN-2025 (+) sterile diluent (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) as prophylaxis (Expired product administered). There was confirmed no temperature excursion (TE), nor additional adverse event (AE).
Sex: M
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: solid tumor cancer; This serious case was reported by a consumer via interactive digital media and described the occurrence of malignant solid tumor in a 80-year-old male 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 malignant solid tumor (Verbatim: solid tumor cancer) (serious criteria GSK medically significant). The outcome of the malignant solid tumor was not reported.   It was unknown if the reporter considered the malignant solid tumor to be related to Shingrix.     The company considered the malignant solid tumor to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a consumer via interactive digital media. The reporter reported the information on booster Shingrix series after 7 years for 80 years old male with solid tumor cancers and taking immunosuppressive drugs.; Sender's Comments: Neoplasm malignant is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: TWO MONTHS LATER I got SHINGLES; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: TWO MONTHS LATER I got SHINGLES) (serious criteria hospitalization). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2025 This case was reported by a patient via interactive digital media. Reporter reported that did not fall for it. He/she did, regrettably, at the urging of his/her brother.  Two months later he/she got shingles. Horribly, horrible, indescribable pain.  Hospitalized for 5 days.  Of course physician said just imagine how much worse it would have been if you had not taken the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Alopecia, Anaemia, Antiphospholipid syndrome, Brain fog
Clinical narrative: - whole body swelling, edema and inflammation (to huge proportions) - major hair loss in clumps - nausea & vomiting - dizziness - pounding headache - blurry eyes - confusing (brain fog) & memory issues - depression - racing heart and agitation - SMy medical odyssey: Medications, Therapies and Supplements I have tried:  - Ivermectin  - Hydroxychloroquine - Ketotifen (for Mast Cell Activation Syndrome - MCAS) - Many supplements (more than 30) - Many anti-histamines - Xifaxan (for Small Intestinal Bacterial Overgrowth (SIBO) - Triple Anti-Coagulation Therapy - Physicians Elemental Diet Powder - Maraviroc anti-viral - Cyclosporine - Ultraviolet blood irradiation and ozone therapy - Muscle and spinal manipulations - Glutathione - Red Light Therapy - Plasmapheresis - Pyridostigmine - Valacyclovir - Phosphatidylserine - Eliquis - Terzepatide - Vitamin B12 shots  My current diagnoses: -Antiphospholipid syndrome (an autoimmune disease) -High risk for blood clots and thrombotic events -SIBO -MCAS -Ehlers-Danlos syndrome -Postural Orthostatic Tachycardia syndrome (POTS) -Hypothalamic dysfunction -Anemia -Headaches -Cytokine Release syndrome  I am still very sick and disabled, nearly 4 years later!
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Cytokine release syndrome, Depression, Dizziness, Ehlers-Danlos syndrome
Clinical narrative: - whole body swelling, edema and inflammation (to huge proportions) - major hair loss in clumps - nausea & vomiting - dizziness - pounding headache - blurry eyes - confusing (brain fog) & memory issues - depression - racing heart and agitation - SMy medical odyssey: Medications, Therapies and Supplements I have tried:  - Ivermectin  - Hydroxychloroquine - Ketotifen (for Mast Cell Activation Syndrome - MCAS) - Many supplements (more than 30) - Many anti-histamines - Xifaxan (for Small Intestinal Bacterial Overgrowth (SIBO) - Triple Anti-Coagulation Therapy - Physicians Elemental Diet Powder - Maraviroc anti-viral - Cyclosporine - Ultraviolet blood irradiation and ozone therapy - Muscle and spinal manipulations - Glutathione - Red Light Therapy - Plasmapheresis - Pyridostigmine - Valacyclovir - Phosphatidylserine - Eliquis - Terzepatide - Vitamin B12 shots  My current diagnoses: -Antiphospholipid syndrome (an autoimmune disease) -High risk for blood clots and thrombotic events -SIBO -MCAS -Ehlers-Danlos syndrome -Postural Orthostatic Tachycardia syndrome (POTS) -Hypothalamic dysfunction -Anemia -Headaches -Cytokine Release syndrome  I am still very sick and disabled, nearly 4 years later!
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal microorganism overgrowth, Generalised oedema, Headache, Hypothalamo-pituitary disorder, Inflammation
Clinical narrative: - whole body swelling, edema and inflammation (to huge proportions) - major hair loss in clumps - nausea & vomiting - dizziness - pounding headache - blurry eyes - confusing (brain fog) & memory issues - depression - racing heart and agitation - SMy medical odyssey: Medications, Therapies and Supplements I have tried:  - Ivermectin  - Hydroxychloroquine - Ketotifen (for Mast Cell Activation Syndrome - MCAS) - Many supplements (more than 30) - Many anti-histamines - Xifaxan (for Small Intestinal Bacterial Overgrowth (SIBO) - Triple Anti-Coagulation Therapy - Physicians Elemental Diet Powder - Maraviroc anti-viral - Cyclosporine - Ultraviolet blood irradiation and ozone therapy - Muscle and spinal manipulations - Glutathione - Red Light Therapy - Plasmapheresis - Pyridostigmine - Valacyclovir - Phosphatidylserine - Eliquis - Terzepatide - Vitamin B12 shots  My current diagnoses: -Antiphospholipid syndrome (an autoimmune disease) -High risk for blood clots and thrombotic events -SIBO -MCAS -Ehlers-Danlos syndrome -Postural Orthostatic Tachycardia syndrome (POTS) -Hypothalamic dysfunction -Anemia -Headaches -Cytokine Release syndrome  I am still very sick and disabled, nearly 4 years later!
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Manipulation, Mast cell activation syndrome, Memory impairment
Clinical narrative: - whole body swelling, edema and inflammation (to huge proportions) - major hair loss in clumps - nausea & vomiting - dizziness - pounding headache - blurry eyes - confusing (brain fog) & memory issues - depression - racing heart and agitation - SMy medical odyssey: Medications, Therapies and Supplements I have tried:  - Ivermectin  - Hydroxychloroquine - Ketotifen (for Mast Cell Activation Syndrome - MCAS) - Many supplements (more than 30) - Many anti-histamines - Xifaxan (for Small Intestinal Bacterial Overgrowth (SIBO) - Triple Anti-Coagulation Therapy - Physicians Elemental Diet Powder - Maraviroc anti-viral - Cyclosporine - Ultraviolet blood irradiation and ozone therapy - Muscle and spinal manipulations - Glutathione - Red Light Therapy - Plasmapheresis - Pyridostigmine - Valacyclovir - Phosphatidylserine - Eliquis - Terzepatide - Vitamin B12 shots  My current diagnoses: -Antiphospholipid syndrome (an autoimmune disease) -High risk for blood clots and thrombotic events -SIBO -MCAS -Ehlers-Danlos syndrome -Postural Orthostatic Tachycardia syndrome (POTS) -Hypothalamic dysfunction -Anemia -Headaches -Cytokine Release syndrome  I am still very sick and disabled, nearly 4 years later!
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Plasmapheresis, Postural orthostatic tachycardia syndrome, Spinal manipulation
Clinical narrative: - whole body swelling, edema and inflammation (to huge proportions) - major hair loss in clumps - nausea & vomiting - dizziness - pounding headache - blurry eyes - confusing (brain fog) & memory issues - depression - racing heart and agitation - SMy medical odyssey: Medications, Therapies and Supplements I have tried:  - Ivermectin  - Hydroxychloroquine - Ketotifen (for Mast Cell Activation Syndrome - MCAS) - Many supplements (more than 30) - Many anti-histamines - Xifaxan (for Small Intestinal Bacterial Overgrowth (SIBO) - Triple Anti-Coagulation Therapy - Physicians Elemental Diet Powder - Maraviroc anti-viral - Cyclosporine - Ultraviolet blood irradiation and ozone therapy - Muscle and spinal manipulations - Glutathione - Red Light Therapy - Plasmapheresis - Pyridostigmine - Valacyclovir - Phosphatidylserine - Eliquis - Terzepatide - Vitamin B12 shots  My current diagnoses: -Antiphospholipid syndrome (an autoimmune disease) -High risk for blood clots and thrombotic events -SIBO -MCAS -Ehlers-Danlos syndrome -Postural Orthostatic Tachycardia syndrome (POTS) -Hypothalamic dysfunction -Anemia -Headaches -Cytokine Release syndrome  I am still very sick and disabled, nearly 4 years later!
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Vomiting
Clinical narrative: - whole body swelling, edema and inflammation (to huge proportions) - major hair loss in clumps - nausea & vomiting - dizziness - pounding headache - blurry eyes - confusing (brain fog) & memory issues - depression - racing heart and agitation - SMy medical odyssey: Medications, Therapies and Supplements I have tried:  - Ivermectin  - Hydroxychloroquine - Ketotifen (for Mast Cell Activation Syndrome - MCAS) - Many supplements (more than 30) - Many anti-histamines - Xifaxan (for Small Intestinal Bacterial Overgrowth (SIBO) - Triple Anti-Coagulation Therapy - Physicians Elemental Diet Powder - Maraviroc anti-viral - Cyclosporine - Ultraviolet blood irradiation and ozone therapy - Muscle and spinal manipulations - Glutathione - Red Light Therapy - Plasmapheresis - Pyridostigmine - Valacyclovir - Phosphatidylserine - Eliquis - Terzepatide - Vitamin B12 shots  My current diagnoses: -Antiphospholipid syndrome (an autoimmune disease) -High risk for blood clots and thrombotic events -SIBO -MCAS -Ehlers-Danlos syndrome -Postural Orthostatic Tachycardia syndrome (POTS) -Hypothalamic dysfunction -Anemia -Headaches -Cytokine Release syndrome  I am still very sick and disabled, nearly 4 years later!
Age: 58.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Amnesia, Feeling cold, Hyperhidrosis, Malaise, Memory impairment
Clinical narrative: Beginning about 24 hours later, had short-term memory issues for about 3 days.  It was like I was half asleep.  I forgot immediate things that I was focused on and discovered them a short time later.  Was traveling for work and left a bag in a  rental car that I later had to retrieve.  Then upon going through airport security on the way home, I put my wallet through the xray and left security without getting the wallet.  I had to go back to security to get it too.   On the night of the 21st, I woke up in a cold, full body sweat.  The forgetfulness and malaise went away after about a week.