chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: PYREXIA (non-serious), outcome "recovered", described as "fever". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: arm swelling and rash; arm swelling and rash; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in 2020 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), RASH (non-serious), outcome "recovered" and all described as "arm swelling and rash".  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.  Additional Information: The patient developed a reaction after receiving the PCV13 pneumococcal vaccine in 2020. The reaction included arm swelling and rash that lasted for a few weeks. Their provider was recommending that he receive Prevnar20 but the patient was concerned about the risks as he does not want to experience another bad reaction.
Vaccine: FLUX
Symptoms: Lung disorder
Clinical narrative: Patient had a severe reaction, which has continued since patient received flu vaccine, It has attached patient lungs; This spontaneous case, initially received on 22-May-2025, with additional information received on 26-May-2025 (being process together), was reported by a non-health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On 29-Jan-2025, the patient received INN Flu Vaccine Seasonal for Indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 388494.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 29-Jan-2025, the Patient had a severe reaction, which has continued since patient received flu vaccine, It has attached patient lungs (outcome: Not Reported).  Patient had a severe reaction, which has continued since patient received flu vaccine on 29-Jan-2025. Lot 388494.  It has attached patient lungs. It happened within few hours after shot. Patient still have trouble which was never there before. 2 weeks before receiving shot patient had a complete check up with patient's cardiologist. All was fine.  INN Flu Vaccine Seasonal action taken: Not Applicable  Reporter's assessment: The reporter did not provide the seriousness and causality assessment of event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Considered related due to plausible temporal relationship (same day within few hours after suspect).
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site discolouration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Injection site reaction: warmth, discoloration, mild itchiness, no pain, no noticeable swelling. Symptoms improving.
Age: 15.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: 15/ Female, received ProQuad MMR V and Varicella Vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Confusional state, Dizziness, Pallor
Clinical narrative: Dizziness. Confusion. Lips turning white. Unconsciousness.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal X-ray, Chest pain, Computerised tomogram abdomen, Computerised tomogram thorax, Dyspnoea
Clinical narrative: After the Covid vaccine was administered I went home and attempted to work out  I was never told not to I got shortness of breath and chest pain. I rested and developed shortness of breath through the years. Last year I was working out and I heard a pop in my left abdomen and can bo longer work out as I get shortness of breath. I attempted to go to a jacuzzi to see if I got relief but the pressure makes me feel like something is going to pop.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Exercise tolerance decreased, Gastrointestinal sounds abnormal, Tachycardia
Clinical narrative: After the Covid vaccine was administered I went home and attempted to work out  I was never told not to I got shortness of breath and chest pain. I rested and developed shortness of breath through the years. Last year I was working out and I heard a pop in my left abdomen and can bo longer work out as I get shortness of breath. I attempted to go to a jacuzzi to see if I got relief but the pressure makes me feel like something is going to pop.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Autoantibody test, Chest X-ray normal, Condition aggravated, Echocardiogram
Clinical narrative: Passing out, POTS flare up and anxiety attack.   Went to hospital.  Labs and chest X-ray were normal at the time.  Afterwards established care with cardiologist, neurologist, ENT, rheumatologist and working on getting a gastrologist.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Laboratory test normal, Loss of consciousness, Magnetic resonance imaging head, Postural orthostatic tachycardia syndrome
Clinical narrative: Passing out, POTS flare up and anxiety attack.   Went to hospital.  Labs and chest X-ray were normal at the time.  Afterwards established care with cardiologist, neurologist, ENT, rheumatologist and working on getting a gastrologist.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus operation
Clinical narrative: Passing out, POTS flare up and anxiety attack.   Went to hospital.  Labs and chest X-ray were normal at the time.  Afterwards established care with cardiologist, neurologist, ENT, rheumatologist and working on getting a gastrologist.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: redness, rash, sore and itch
Age: 12.0
Sex: F
Vaccine: RAB
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria involving 2/3 of affected upper arm on date of admission.  Recurrent hives ever since at injection site
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Trigger finger
Clinical narrative: Immediate onset of trigger finger, middle finger of right hand.  Never had symptoms previously.
Age: 81.0
Sex: F
Vaccine: PNC21
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED CAPVAXIVE ON 5/16/25. A FEW DAYS PRIOR SHE INQUIRED ABOUT GETTING THE VACCINE AND THE PATIENT WAS UNSURE IF SHE'S GOTTEN A PREVIOUS DOSE OF PNEUMONIA. WE TOLD HER TO FOLLOW-UP WITH HER DOCTOR. THE PHARMACY ALSO PUT IN A CALL TO THE DOCTOR ASKING WHICH VACCINE WE SHOULD ADMINISTERED. THE NEXT TIME THE PATIENT CAME IN SHE SAID THAT HER DOCTOR GAVE HER THE OKAY TO GET THE VACCINE BECAUSE SHE DID NOT GET ANY PREVIOUS SHOT. WE ADMINISTERED THE SHOT ON 5/16/25. A FEW DAYS LATER THE DOCTOR CALLED BACK TO RETURN OUR CALL ONLY TO BE TOLD BY THE DOCTOR'S OFFICE THAT THE PATIENT ALREADY RECEIVED PREVNAR 20 A FEW DAYS BEFORE 5/16/25. PATIENT HAS NOT REPORTED ANY SIDE EFFECTS.
Age: 70.0
Sex: M
Vaccine: UNK, RSV
Symptoms: Arthralgia, Blood test, Gait disturbance, Muscle spasms, Myalgia
Clinical narrative: profound persistent systemic inflammatory syndrome resembling polymyalgia rheumatica without CPK elevation. Transient positive RF in setting of massive inflammatory state (ESR >100 and CRP>300); Negative ANA. Steroid responsive but relapsed after initial and subsequent 2 month steroid regimens. Now requiring initiation of MTX steroid sparing immunosuppressants.
Age: 70.0
Sex: M
Vaccine: UNK, RSV
Symptoms: Neck pain, Night sweats, Pain in extremity, Sleep disorder
Clinical narrative: profound persistent systemic inflammatory syndrome resembling polymyalgia rheumatica without CPK elevation. Transient positive RF in setting of massive inflammatory state (ESR >100 and CRP>300); Negative ANA. Steroid responsive but relapsed after initial and subsequent 2 month steroid regimens. Now requiring initiation of MTX steroid sparing immunosuppressants.
Age: 70.0
Sex: M
Vaccine: UNK, RSV
Symptoms: Antinuclear antibody negative, Blood creatine phosphokinase normal, C-reactive protein increased, Red blood cell sedimentation rate increased, Systemic inflammatory response syndrome
Clinical narrative: profound persistent systemic inflammatory syndrome resembling polymyalgia rheumatica without CPK elevation. Transient positive RF in setting of massive inflammatory state (ESR >100 and CRP>300); Negative ANA. Steroid responsive but relapsed after initial and subsequent 2 month steroid regimens. Now requiring initiation of MTX steroid sparing immunosuppressants.
Age: 16.0
Sex: F
Vaccine: MNP, MNP
Symptoms: Computerised tomogram abnormal, Computerised tomogram pelvis abnormal, Fatigue, Hypokalaemia, Hypomagnesaemia
Clinical narrative: Fever; Joint Pain; Body ache; fatigue; The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27May2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician from a sales representative.  A 16-year-old female patient received meningococcal group abcwy vaccine (PENBRAYA), on 23Apr2025 as dose 1, single (Lot number: LJ0077) at the age of 16 years intramuscular for immunisation, Device Lot Number: LJ0077. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Body ache"; PYREXIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Fever"; ARTHRALGIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Joint Pain"; FATIGUE (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025). The patient was hospitalized for pyrexia, arthralgia, pain, fatigue (start date: 2025, discharge date: 2025, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of pyrexia, arthralgia, pain, fatigue (IV fluid). Additional information: The office has been using Penbraya since last summer. Doctor said she was seeing a lot more adverse events since using Penbraya verses individual separate vaccines: Fever (one adolescent went to hospital along with other symptoms), joint pain, muscle pain, pain at injection site, and body aches (reported as a general observation). As a general practice, doctor was advising patients to take Tylenol after vaccination.; Sender's Comments: There is a reasonable possibility that the events pyrexia, arthralgia, and fatigue were related to PENBRAYA based on known drugs safety profile and temporal relationship. The association between the event pain with PENBRAYA can not be fully excluded with the currently available information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: MNP, MNP
Symptoms: Laboratory test abnormal, Leukocytosis, Oedema, Pain, Pain in extremity
Clinical narrative: Fever; Joint Pain; Body ache; fatigue; The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27May2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician from a sales representative.  A 16-year-old female patient received meningococcal group abcwy vaccine (PENBRAYA), on 23Apr2025 as dose 1, single (Lot number: LJ0077) at the age of 16 years intramuscular for immunisation, Device Lot Number: LJ0077. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Body ache"; PYREXIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Fever"; ARTHRALGIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Joint Pain"; FATIGUE (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025). The patient was hospitalized for pyrexia, arthralgia, pain, fatigue (start date: 2025, discharge date: 2025, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of pyrexia, arthralgia, pain, fatigue (IV fluid). Additional information: The office has been using Penbraya since last summer. Doctor said she was seeing a lot more adverse events since using Penbraya verses individual separate vaccines: Fever (one adolescent went to hospital along with other symptoms), joint pain, muscle pain, pain at injection site, and body aches (reported as a general observation). As a general practice, doctor was advising patients to take Tylenol after vaccination.; Sender's Comments: There is a reasonable possibility that the events pyrexia, arthralgia, and fatigue were related to PENBRAYA based on known drugs safety profile and temporal relationship. The association between the event pain with PENBRAYA can not be fully excluded with the currently available information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: MNP, MNP
Symptoms: Pyrexia
Clinical narrative: Fever; Joint Pain; Body ache; fatigue; The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27May2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician from a sales representative.  A 16-year-old female patient received meningococcal group abcwy vaccine (PENBRAYA), on 23Apr2025 as dose 1, single (Lot number: LJ0077) at the age of 16 years intramuscular for immunisation, Device Lot Number: LJ0077. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Body ache"; PYREXIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Fever"; ARTHRALGIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Joint Pain"; FATIGUE (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025). The patient was hospitalized for pyrexia, arthralgia, pain, fatigue (start date: 2025, discharge date: 2025, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of pyrexia, arthralgia, pain, fatigue (IV fluid). Additional information: The office has been using Penbraya since last summer. Doctor said she was seeing a lot more adverse events since using Penbraya verses individual separate vaccines: Fever (one adolescent went to hospital along with other symptoms), joint pain, muscle pain, pain at injection site, and body aches (reported as a general observation). As a general practice, doctor was advising patients to take Tylenol after vaccination.; Sender's Comments: There is a reasonable possibility that the events pyrexia, arthralgia, and fatigue were related to PENBRAYA based on known drugs safety profile and temporal relationship. The association between the event pain with PENBRAYA can not be fully excluded with the currently available information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: MNP, MNP
Symptoms: Arthralgia, Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Joint Pain; Body ache; fatigue; The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27May2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician from a sales representative.  A 16-year-old female patient received meningococcal group abcwy vaccine (PENBRAYA), on 23Apr2025 as dose 1, single (Lot number: LJ0077) at the age of 16 years intramuscular for immunisation, Device Lot Number: LJ0077. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Body ache"; PYREXIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Fever"; ARTHRALGIA (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025), described as "Joint Pain"; FATIGUE (hospitalization, medically significant) with onset 23Apr2025, outcome "recovered" (2025). The patient was hospitalized for pyrexia, arthralgia, pain, fatigue (start date: 2025, discharge date: 2025, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of pyrexia, arthralgia, pain, fatigue (IV fluid). Additional information: The office has been using Penbraya since last summer. Doctor said she was seeing a lot more adverse events since using Penbraya verses individual separate vaccines: Fever (one adolescent went to hospital along with other symptoms), joint pain, muscle pain, pain at injection site, and body aches (reported as a general observation). As a general practice, doctor was advising patients to take Tylenol after vaccination.; Sender's Comments: There is a reasonable possibility that the events pyrexia, arthralgia, and fatigue were related to PENBRAYA based on known drugs safety profile and temporal relationship. The association between the event pain with PENBRAYA can not be fully excluded with the currently available information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 11.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: No adverse event, Product preparation error
Clinical narrative: inappropriate use due to dilution of menquadfi with sterile saline with no reported adverse event; Initial information received on 28-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient for who inappropriate use due to dilution of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] with sterile saline 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) both for Immunisation.  On 27-May-2025, the patient received an unknown dose (1.2ml) 1X (once) inappropriate use due to dilution of meningococcal a-c-y-w135 (t conj) vaccine; Solution for injection (Strength = standard) (lot U8369AA with expiry date 01-MAR-2028) via intramuscular route in the left deltoid for Immunization; with sterile saline with no reported adverse event (product preparation error) (latency: same day).  Reportedly: he needs to readminister a menquadfi dose. She stated she thought it was a powder that needed to be reconstituted, so they added 0.7 ml of sterile saline to the 0.5 ml dose, diluting it to a volume of 1.2 ml total.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ, MEN
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to dilution of menquadfi with sterile saline with no reported adverse event; Initial information received on 28-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient for who inappropriate use due to dilution of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] with sterile saline 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) both for Immunisation.  On 27-May-2025, the patient received an unknown dose (1.2ml) 1X (once) inappropriate use due to dilution of meningococcal a-c-y-w135 (t conj) vaccine; Solution for injection (Strength = standard) (lot U8369AA with expiry date 01-MAR-2028) via intramuscular route in the left deltoid for Immunization; with sterile saline with no reported adverse event (product preparation error) (latency: same day).  Reportedly: he needs to readminister a menquadfi dose. She stated she thought it was a powder that needed to be reconstituted, so they added 0.7 ml of sterile saline to the 0.5 ml dose, diluting it to a volume of 1.2 ml total.  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: 71.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash
Clinical narrative: rash on her arm where she got the injection and it also started on her legs; her arm was swollen at the injection site; headache; indication: Pneumococcal; Information has been received from a 71 years old female patient and referred to herself. The patient had no medical history. The patient's concurrent conditions included allergic to aspirin, penicillin, levothyroxine, and sulfamethoxazole (+) trimethoprim (BACTRIM). Concomitant therapy included "METHROTREC" 10mg once weekly, the patient was advised to stop the medication during the week she got the vaccine.   On 20-MAY-2025, the patient vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection (strength, dose, frequency, route, lot # and expiration date were not reported) for Pneumococcal (Product use in unapproved indication). She thought she was receiving the Pneumococcal vaccine conj 20v (CRM197)(PREVNAR 20), however she was administered Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE).  On 21-MAY-2025 (the second day after she received the vaccine), the patient's arm was swollen at the injection site (Vaccination site swelling) and she had a headache. On 25-MAY-2025 (the day five), she started getting a rash on her arm where she got the injection, and it also started on her legs and the rash lessens when she wears loose clothes (Rash). The reporter said the rash was better but has not gone away, the outcome of the event rash was considered as recovering.  The outcome of other events of Vaccination site swelling and headache was reported as not recovered.   The causal relationship between the events of Vaccination site swelling, Headache, Rash and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.   Lot# is being requested and will be submitted if received.
Age: 71.0
Sex: F
Vaccine: PNC21, PNC21
Symptoms: Headache, Injection site rash, Injection site swelling, Rash
Clinical narrative: rash on her arm where she got the injection and it also started on her legs; her arm was swollen at the injection site; headache; indication: Pneumococcal; Information has been received from a 71 years old female patient and referred to herself. The patient had no medical history. The patient's concurrent conditions included allergic to aspirin, penicillin, levothyroxine, and sulfamethoxazole (+) trimethoprim (BACTRIM). Concomitant therapy included "METHROTREC" 10mg once weekly, the patient was advised to stop the medication during the week she got the vaccine.   On 20-MAY-2025, the patient vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Injection (strength, dose, frequency, route, lot # and expiration date were not reported) for Pneumococcal (Product use in unapproved indication). She thought she was receiving the Pneumococcal vaccine conj 20v (CRM197)(PREVNAR 20), however she was administered Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE).  On 21-MAY-2025 (the second day after she received the vaccine), the patient's arm was swollen at the injection site (Vaccination site swelling) and she had a headache. On 25-MAY-2025 (the day five), she started getting a rash on her arm where she got the injection, and it also started on her legs and the rash lessens when she wears loose clothes (Rash). The reporter said the rash was better but has not gone away, the outcome of the event rash was considered as recovering.  The outcome of other events of Vaccination site swelling and headache was reported as not recovered.   The causal relationship between the events of Vaccination site swelling, Headache, Rash and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.   Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Accident at work, Accidental exposure to product, Injury associated with device, Syringe issue
Clinical narrative: Accidental exposure; FBE calling on behalf a nurse who reported GARDASIL 9 syringe had broken and injured another nurse in the practice while administering product on 22APR2025.  Filing AE for the nurse injury and filing potential patient AE as it was not confirmed durin; FBE calling on behalf a nurse who reported GARDASIL 9 syringe had broken and injured another nurse in the practice while administering product on 22APR2025. Filing AE for the nurse injury and filing potential patient AE as it was not confirmed durin; This spontaneous report was received from a Nurse and refers to a(n) female patient of unknown age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 22-Apr-2025, an unknown patient would be vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot # and expiration date were not reported), as prophylaxis (Case # 2282009); however, during the vaccination procedure, the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) syringe had broken and injured a nurse in the practice while administering product (syringe broken, injury associated with device, accidental exposure to product). The outcome of the event was not reported.
Age: 5.0
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: no adverse event; HCP called and reported a patient who did not receive a full dose of PROQUAD on 13MAY2025 due to moving their arm during administration. Limited demographics provided. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a 5-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.   On 13-May-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, frequency, route of administration, lot # and expiration date were not reported) as a prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date were not provided). On 13-May-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). However, the patient did not receive a full dose of due to moving their arm during administration (accidental underdose). No additional information was known by reporter.
Sex: M
Vaccine: MMRV, MMRV, MMRV, MMRV, MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient received PROQUAD dose on  3/14/2024,  1/31/2025 and  on 3/14/2025; This spontaneous report was received from a medical assistant on 13-MAY-2025 and refers to a male patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  Historical vaccines include Measles, mumps, and rubella virus vaccine live (MMRII) and Varicella virus vaccine live (Oka/Merck) (VARIVAX) ad mistered on 01-FEB-2024.  On 14-MAR-2024 at another clinic, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD),  (lot#, expiration date, dose number, anatomical location, route of administration were not reported) and with sterile diluent (MERCK STERILE DILUENT) (lot#, expiration date, dose number, anatomical location, route of administration were not reported) for Prophylaxis.  The Medical assistant reported that on 31-JAN-2025  and 14-MAR-2025  , the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y015355, expiration date: 10-MAR-2026), dose 0.5 mL (conflicting information reported as first and second dose respectively by the same reporter) (dose number, anatomical location, route of administration were not reported) and with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (Extra dose administered). No additional adverse event or quality complaint was reported. No additional Adverse events reported.
Age: 31.0
Vaccine: MMRV, MMRV
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; a 31 year old patient was administered both PROQUAD and VARIVAX on 4/16/2025.; PROQUAD was given to a 31-year-old patient; A dose of VARIVAX was given previously on 3/17/2025 and a dose of PROQUAD was given on 3/21/2025 to the same patient.; This spontaneous report was received from a nurse on 27-May-2025 and refers to a 31-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.   On 17-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #Y014939, expiration date: 04-Sep-2026) 0.5 ml, administered by Intramuscular route. On 21-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y000225, expiration date: 03-Jan-2026) 0.5 mL, administered by Intramuscular route (Product administered to patient of inappropriate age, Inappropriate schedule of product administration). On 16-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #Y014939, expiration date: 04-Sep-2026) 0.5 ml, administered by Intramuscular route and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017208, expiration date: 13-Apr-2026) 0.5 mL, administered by Intramuscular route (overdose). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date unknown). The vaccines were administered as prophylaxis. No additional AE (no adverse event).
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Seizure
Clinical narrative: Grandmother of patient reporting that patient began having seizures after having GARDASIL administered. She is not sure if it was GARDASIL or GARASIL 9. She says it was administered a year or two ago. She does not have any additional information and; This spontaneous report was received from the patient's grandmother and refers to a female patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   In approximately 2023, reported as "a year or two ago", the patient was vaccinated with the company unidentified Human Papillomavirus (HPV) vaccine (name and lot number not provided), administered by Unknown route (reported as "Injection") for the indication "vaccine".  On an unknown date, after having the vaccine, the patient began having seizures. The reporter did not have any additional.   At the reporting time, the outcome of seizures was unknown.   The causal relationship between the event the company unidentified Human Papillomavirus (HPV) vaccine was not reported.    Upon internal review, the event of seizure was determined to be medically significant.   Additional information is not expected.
Vaccine: HBHEPB
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report a patient was administered PEDVAXHIB today 5/28/2025 after the expiration date of 5/8/2025.; This spontaneous report was received from a health care professional referring to a patient.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 28-MAY-2025, the patient was vaccinated with an expired dose of Haemophilus B conjugate vaccine (Meningococcal protein conjugate) suspension for injection (PEDVAXHIB), for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number W032685, with expiration date on 08-MAY-2025) (Expired product administered). There was not adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain in the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2025, the patient received Shingles vaccine. In APR-2025, an unknown time after receiving Shingles vaccine, the patient experienced muscle pain (Verbatim: muscle pain in the arm). The outcome of the muscle pain was not reported.   It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine.     It was unknown if the company considered the muscle pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient via interactive digital media. The reporter's mother had muscle pain in the arm for a month and a half since the vaccine was given. The muscle pain since vaccine administration one month ago.
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion occurred with max/low temp. reached 63.0 F for 96 hours with no reported adverse event; Initial information received on 27-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves temperature excursion of Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] occurred with max/low temp. reached 63.0 f for 96 hours with no reported adverse event.  On an unknown date, the caller reported that an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis vaccine Suspension for injection (lot U8339BA and expiry date-30-Nov-2026) (strength-unknown) via unknown route in unknown administration site for Immunization with max/low temp. reached 63.0 f for 96 hours with no reported adverse event (product storage error).  Reportedly- extended stability data does not cover the excursion, human error was involved (door was left open), The product was not administered  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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: only the liquid portion of pentacel was given to a patient with no reported adverse event; Initial information received on 28-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown age and gender who was administered with only the liquid portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] 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 Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (lot UK225AB, expiry date 31-Jul-2026; strength standard and frequency once) via unknown route in unknown administration site for Immunization and only the liquid portion of pentacel was given to a patient with no reported adverse event (single component of a two-component 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: 6.0
Sex: F
Vaccine: MMR
Symptoms: Confusional state, Crying, Hypotonia, Staring, Unresponsive to stimuli
Clinical narrative: Possible seizure, and started blankly into space for about 15 to 20 seconds, was completely limp and unresponsive.  Then was sobbing and confused after.
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs; patient supposed to only receive VARIVAX but also received PROQUAD along with VARIAVX; This spontaneous report was received from a medical assistant 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 27-MAY-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (strength, dose, route, lot #, and expiration date of both vaccines were not reported). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The patient was supposed to only receive Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) but also received Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) along with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (Overdose). No additional adverse events were reported.  Lot# is being requested and will be submitted if received.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; that improperly stored VARIVAX was administered; This spontaneous report was received from a Physician and referred 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 28-May-2025, the patient was vaccinated with improperly stored Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #Y020586, expiration date: 17-Dec-2026) 0.5 mL (0.5 mL) for prophylaxis (Improper storage of product in use). Temperature was 40F, Time frame was 2 hours 0 minutes 0 seconds. No previous temperature excursion. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date not reported). No additional AE.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 23-MAY-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 23-MAY-2025 This case was reported by a patient via interactive digital media. The patient got two vaccines and was diagnosed with shingles on the day of reporting. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 ) and Shingles vaccine (dose 2).
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: area of injection is sore; injection site is has a 4 by 4 red area; is warm to the touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21-MAY-2025, the patient received Shingles vaccine. In MAY-2025, less than a week after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: area of injection is sore), injection site erythema (Verbatim: injection site is has a 4 by 4 red area) and injection site warmth (Verbatim: is warm to the touch). The outcome of the injection site pain was resolving and the outcome of the injection site erythema and injection site warmth were not reported.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, injection site erythema and injection site warmth to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient reported that he/she got a shingles vaccine shot on May 21st and area of injection was sore but getting better. However have a large red area about 4 by 4 and is warm to the touch.  The injection site is has a 4 by 4 red area.  The reporter enquired if that was normal.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot of Shingrix in 2022 but did not go back for my second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: first shot of Shingrix in 2022 but did not go back for my second shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 26-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient reported he/she received first shot of Shingrix in 2022 but did not go back for his/her second shot which led to incomplete course of vaccination.  The patient enquired if they need to start over with the vaccine or just get my second shot.