chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: received an extra dose of MENQUADFI instead of the intended MENB with no reported AE; received an extra dose of MENQUADFI instead of the intended MENB with no reported AE; Initial information received on 11-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient who had received an extra dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] instead of the intended MENB (Meningococcal Vaccine B) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 23-Oct-2018 he also received a dose 1 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) with an unknown batch number via unknown route in unknown administration site, On 06-Feb-2024, the patient received a dose 2 of same vaccine lot number not reported via unknown route in unknown administration site. On 11-Feb-2025 he also received a dose 3 of 0.5 ml of vaccine U8351BA, Expiry date; 31-Mar-2028, strength was unknown via intramuscular route in the left deltoid for Immunization and received an extra dose of menquadfi instead of the intended menb with no reported adverse event (wrong product administered) and (extra dose 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: 18.0
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient was accidentally given MENQUADFI, earlier than scheduled with no reported AE; Initial information received on 11-Feb-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 18 years old female patient who was accidentally given Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] earlier than scheduled with no reported ae (adverse event).  The patient's past vaccination(s) included MENACTRA on 22-JAN-2018 with dose 1. The patient's past medical history, medical treatment(s) and family history were not provided.  On 10-Mar-2023, the patient received a dose 2 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization. On 11-Feb-2025was accidentally given menquadfi dose 3, Solution for injection, dose 0.5 ml1x(once) lot U8369BA expiry- 31-MAR-2028 via intramuscular route in the left deltoid, earlier than scheduled with no reported ae (inappropriate schedule of product administration) (latency same day). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: MEN
Symptoms: No adverse event, Product preparation error
Clinical narrative: inappropriate use due to use of incorrect diluent with no reported adverse event; Initial information received on 12-Feb-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient with  inappropriate use due to use of incorrect diluent with no reported adverse event with Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Immunization, inappropriate use due to use of incorrect diluent with no reported adverse event (product preparation error) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4-month-old patient got the FLUZONENP shot by accident, with no reported adverse event; Initial information received on 12-Feb-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a  4-month-old patient got the Influenza USP trival A-B subvirion no preservative vaccine (Fluzonenp) shot by accident, 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 Rotavirus vaccine: and diphtheria, tetanus, AC pertussis, IPV and HIB vaccine (Pentacel).   On 11-Feb-2025, the 4-month-old patient received a 0.5 ml dose of suspect Influenza USP trival A-B subvirion no preservative vaccine Suspension for injection, strength-standard (lot U8518AA) (expiry date- 30-Jun-2025) via intramuscular route in Right Vastus Lateralis for influenza immunization (Influenza immunisation) and shot by accident, with no adverse event reported (product administered to patient of inappropriate age) (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: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: rash breakout; Initial information received on 12-Feb-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional(Patient).  This case involves a 75 years old male patient who experienced rash breakout after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine rgE (CHO) (Shingrix) for Immunisation.  On 30-Sep-2024, the patient received a unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) strength, expiry date, lot number not reported via unknown route in the upper left arm for Influenza. The information on batch number corresponding to the one at time of event occurrence was requested.  On an unknown date in OCT-2024 the patient developed rash breakout (rash) (latency: 1 week approximately) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine.  Reportedly "Doctor prescribed them antibiotics but information regarding the antibiotics was not available. When this did not work, they started seeing a dermatologist who prescribed them with clobetasol. They said that this did not work as well so they were prescribed this time with Prednisone. For a while, this worked but whenever the Prednisone was tapered, their rashes would return. They were prescribed on a higher dose but the same pattern repeats. Now, they are being considered for the use of Dupixent.They said that they have been dealing with these rash breakouts for four months now. "  Action taken was not applicable.  The patient was treated with Clobetasol propionate (Clobetasol) and Prednisone.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event rash breakout.
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of imovax rabies with no reported ae; Initial information received on 13-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who  received an expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] with no reported ae (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 expired RABIES (HDC) VACCINE dose 1 mg Powder and solvent for suspension for injection (strength, batch unknown) expiry-30-Nov-2024 via unknown route in unknown administration site for pre-exposure prophylaxis (Immunization) with no reported ae (expired product administered) (same day latency). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DTAP
Symptoms: Pruritus
Clinical narrative: systemic itching; Initial information received on 13-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age male patient who experienced systemic itching after receiving Diphtheria, Tetanus and Acellular Pertussis Vaccine.  The patient's past vaccination(s) included TDAP.  The patient's past medical history, medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing Seasonal allergy.  Concomitant medications included Cetirizine hydrochloride (Zyrtec); and Diphenhydramine hydrochloride (Benadryl).  On an unknown date, the patient received an unknown dose of suspect Diphtheria, Tetanus and Acellular Pertussis Vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization.Information regarding batch number corresponding to the one at time of event occurrence is requested.  On an unknown date the patient developed systemic itching (pruritus) (unknown latency).  Action taken was not applicable.  Reportedly, They said that their husband takes Zyrtec every night as well and that the itching might have been worse if not for the Zyrtec. They said that they supplement Zyrtec with Benadryl just so their husband could sleep.Caregiver said that their husband has had Tdap in the past without any reactions  It was not reported if the patient received a corrective treatment for the event (systemic itching).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event systemic itching.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered, No adverse event
Clinical narrative: ADACEL was first given during her 28th week of pregnancy (28Jan2025) and the second shot was given on her 30th week (13Feb2025) (with no reported adverse event); received ADACEL two weeks apart in her third trimester of pregnancy (with no reported adverse event); Initial information received on 13-Feb-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves 19 years old female patient who was exposed to diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]  two weeks apart in her third trimester of pregnancy (first given during her 28th week of pregnancy (28-Jan-2025) and the second shot was given on her 30th week) (13-Feb-2025) (with no reported adverse event). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The date of last menstrual period was reported as 16-Jul-2024. The estimated due date is 22-Apr-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.  On 28-Jan-2025, the pregnant patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (exposure during pregnancy) and on 13-Feb-2025, the patient received another dose of 0.5 ml of same vaccine, both with suspension for injection (lot number U8115AA) (strength and expiry date not reported) via unknown route in the left arm for immunization with no reported adverse event (extra dose administered) (Latency: same day).   Action taken was not applicable.  Additionally, at time of reporting, the pregnancy is still ongoing.  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: 13.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 13-year-old male that received an expired dose of IPOL, with no reported adverse event; Initial information received on 13-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old male patient who received an expired dose of IPV (Vero) [Ipol]. with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Feb-2025, the patient received an expired unknown dose of suspect IPV (Vero), Suspension for injection, Unknown Strength, Expiry date 10-Feb-2025,  lot W1A101M via intramuscular route in unknown administration site for immunization with no reported adverse event (Expired 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: 13.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of expired IPOL to a child with no adverse event; Initial information received on 14-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old male patient who was administered with an expired poliomyelitis vaccine (INACTIVATED) [IPOL] with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Feb-2025, the patient received 0.5 ml of expired IPV (VERO) Suspension for injection with standard strength (expiry date- 10-Feb-2025 and lot W1A101M) once via intramuscular route in the arm NOS (not otherwise specified) as Immunization with no adverse event (expired product administered) (latency- same day).   Reportedly, Practice manager wanted to know if they should be expecting any adverse events and if the IPOL was still good to use three days after the expiration date.   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: 43.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: stated they gave IPOL to a patient and she misread the expiration date 10Feb2026 but she later found out that it was 10 Feb2025 with no adverse event; Initial information received on 14-Feb-2025 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 43 years old female patient where it was stated they gave IPV (VERO) [IPOL] to a patient and she misread the expiration date 10feb2026 but she later found out that it was 10 feb2025 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Feb-2025, they gave 0.5 ml dose of suspect IPV (VERO) lot W1A101M via intramuscular route in the left arm to a patient and she misread the expiration date 10feb2026 but she later found out that it was (expiry date- 10 feb2025) with no adverse event (expired product administered) (latency- same day).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: punctured IPOL was exposed to Highest/lowest temperature reached: lowest of 33.8°F Duration of excursion: 6 to 7 hours, with no reported adverse event; punctured IPOL was administered after excursion with no reported adverse event; Initial information received on 14-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom had received punctured  IPV (VERO) [IPOL] was exposed to highest/lowest temperature reached: lowest of 33.8°f duration of excursion: 6 to 7 hours and administered after excursion 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 a unknown (dose 1) dose of suspect IPV (Vero) suspension for injection (strength: unknown, expiry date: 21-Apr-2025 and lot W1C831M) via unknown route in unknown administration site as prophylactic vaccination (immunization) (poor quality product administered) (same day latency) and was exposed to highest/lowest temperature reached: lowest of 33.8°f duration of excursion: 6 to 7 hours, with no reported adverse event (product storage error) (unknown latency).  Reportedly: "She confirmed there was an excursion a few times a day and it happened a couple of months ago. They just downloaded the temperature log. She mentioned that when they set the temperature, it's always at 39°F to 40°F and because they're not open when the clinic is closed, the temperature may have gone down. She also said it may be the refrigerator cycle but she doesn't really know what caused it. Previous excursion: None, the extended stability data cover the excursion for the unopened vaccines. No for the opened Ipol. If negative advice, the products have been administered post excursion, 1 dose of Ipol, 2 doses of Tenivac, and 1 dose of Adacel. The punctured IPOL was administered to a patient post excursion; 1 dose was given. She said she only had the excursion of information and that she'd relay the stability data to their doctors."  Action taken: not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Hib component was not reconstituted with the DTaP-IPV component, resulting in the four-month-old patient receiving only the DTaP-IPV component, with no reported adverse event; Initial information received on 17-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient where hib component was not reconstituted with the dtap-ipv component, resulting patient receiving only the dtap-ipv component, of vaccine 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 17-Feb-2025, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot- UC107AA and expiry date- 30-SEP-2025) via intramuscular route in the left leg (dose and strength: not provided) for Immunization and hib component was not reconstituted with the dtap-ipv component, resulting in the patient receiving only the dtap-ipv component, with no reported adverse event (single component of a two-component product administered) (latency- same day).  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Imaging procedure, Laboratory test normal, Pain, Pyrexia
Clinical narrative: Shortness of breath; fever; body pain; This non-serious case was reported by a other health professional and described the occurrence of shortness of breath in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 99Y4J, expiry date 27-OCT-2026) for prophylaxis.   On 12-NOV-2024, the patient received Shingrix (intramuscular) .5 ml. On 12-NOV-2024, less than a day after receiving Shingrix, the patient experienced shortness of breath (Verbatim: Shortness of breath), fever (Verbatim: fever) and general body pain (Verbatim: body pain). On 13-NOV-2024, the outcome of the shortness of breath, fever and general body pain were resolved (duration 1 day).   It was unknown if the reporter considered the shortness of breath, fever and general body pain to be related to Shingrix.     It was unknown if the company considered the shortness of breath, fever and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JAN-2025 The patient was seen in the clinic on 13th November 2024. They were advised to be seen in emergency room. The patient was transported to emergency room, and labs and imaging were completed, all of which were normal. the patient was given medication and sent home.
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: it hurt like hell/ sore arm; barely move his/her arm for a day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose of vaccine on an unknown date and had pain in arm, refer case US2025AMR010514).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: it hurt like hell/ sore arm) and mobility decreased (Verbatim: barely move his/her arm for a day). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm was not reported and the outcome of the mobility decreased was resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and mobility decreased to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2025AMR010514   Additional Information: GSK Receipt Date: 25-JAN-2025 This case was reported by a patient via interactive digital media. Patient was the reporter. It was fine for him/her.  But of course everyone was different. It was 2 shots and it hurt like hell. Especially the 2nd shot.  If he/she recalled, he/she could barely move his/her arm for a day or so.  He/she had been vaccinated for shingles for 7 years with no problems other than a sore arm when he/she got the shots. For tolerance to 1st dose, refer case US2025AMR010514.; Sender's Comments:  US-GSK-US2025AMR010514:same patient, 1st dose
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: All things being equal, I'd rather three days of feeling awful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (Received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feels awful (Verbatim: All things being equal, I'd rather three days of feeling awful). The outcome of the feels awful was resolved (duration 3 days).   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.     It was unknown if the company considered the feels awful to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient go the two shot vaccine.  Glad it was only a two shot series as patient would not had gone back for a third. The immune response to the second vaccine laid patient out for three days.  Reporter added all things being equal, patient had rather three days of feeling awful than three months with an outbreak.
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Powder portion with a different diluent; Powder portion with a different diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB043A, expiry date 30-JUL-2025) for prophylaxis.   On 15-JAN-2025, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Powder portion with a different diluent) and inappropriate dose of vaccine administered (Verbatim: Powder portion with a different diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-JAN-2025 Pharmacist might have mixed the powder with sterile water for injection instead of the diluent that comes with the product, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. So just trying to see if they had any information, if they just gave the second bottle on its own, or if they needed to re-dose the whole thing. During the call, the healthcare professional mentioned that in their inventory they only had the liquid portion for the Menveo, so they thought that the powder portion might have been administered with sterile water for injection.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: A 45 years old female patient received a pediatric dose of Havrix.; underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 45-year-old female patient who received HAV (Havrix pediatric) (batch number J4K4X, expiry date 28-DEC-2026) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: A 45 years old female patient received a pediatric dose of Havrix.) and underdose (Verbatim: underdose). The outcome of the adult use of a child product and underdose were unknown.   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: 20-FEB-2025 The health care professional reported that they administered a pediatric dose of Havrix to a 45 years old female  patient, which led to adult use of a child product and underdose. The reporter was ask what is the protocol to follow.
Age: 20.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presents to clinic c/o L upper arm redness, swelling, pain, and heat to the touch since 23FEB2025 after receiving Anthrax vaccine on 22FEB2025. Patient provided follow-up instructions for expanding swelling and provided Benadryl PRN and cold compresses for symptom management.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Severe pain in shoulder beginning day after injection. Severe pain lasted for approximately 1 months and limited range of motion, ability to participate in sports and other physical activities that were actively being done prior to shot. As of the date of this submission (2/24/2025) pain continues but is more moderate that the first month. Range of motion has improved, but pain still limits full activity engaged in previously and interferes with sleep.
Age: 71.0
Sex: F
Vaccine: PNC21
Symptoms: Angioedema
Clinical narrative: Angio Edema - per patient  Admitted to hospital 7 x days
Age: 11.0
Sex: F
Vaccine: HPV9, MNP
Symptoms: Injected limb mobility decreased, Injection site rash, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: Raised pink rash down and across her upper arm (left); arm swelling and arm pain, limited mobility for 4 days- given steroid cream and Benadryl.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Migraine, Neuralgia
Clinical narrative: extreme fatigue, rashes similar to Lupas
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Systemic lupus erythematosus rash, Tachycardia
Clinical narrative: extreme fatigue, rashes similar to Lupas
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Immediate post-injection reaction, Mobility decreased
Clinical narrative: Shot hurt immediately-given at shoulder -felt like 2 Tdap injections given- now having trouble moving arm back, or up and down, hurts even at rest -feel I have traumatic bursitis
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Injection site vesicles, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: blister about 2 inches above the injection site-Mild, Other Vaccines:  VaccineTypeBrand: flucelvax trival; Manufacturer: seqirus; LotNumber: 946638; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 70.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient came into pharmacy for recommendation. Redness, swelling, and itching on the front biceps/forearm that does not limit mobility but is bothersome to patient. Occured the day after receiving vaccine and seems to get slightly worse each day. Was given recommendation of ice packs and benadryl. Patient have already contacted primary doctor.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Weakness-Medium
Age: 37.0
Sex: M
Vaccine: PNC21
Symptoms: Diarrhoea, Injection site pain, Vomiting
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Diarrhea-Medium, Systemic: Vomiting-Medium
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: Patient is complaining of having severe injection site pain after getting the vaccine. The pain reduced slightly but still moderately painful and will visit urgent care. Advised to check up on any signs of infection and possibly for nerve damage
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Chills, Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Chills-Mild, Additional Details: patient complained of chills and abdominal pain radiatating around navel and lowering below and to side of navel, chills went away and patient did not complain of fever
Age: 58.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: pt reported to the pharmacy on 02/18/2025 with the rash that happned on 2/17/2025 around injection site. , Other Vaccines:  VaccineTypeBrand: boostrix tdap; Manufacturer: gsk; LotNumber: L5229; Route: IM; BodySite: Right arm; Dose: ; VaxDate: UNKNOWN
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines:  VaccineTypeBrand: Shingrix; Manufacturer: ; LotNumber: K2BB7; Route: IM; BodySite: L Arm; Dose: ; VaxDate: UNKNOWN
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysphagia, Dyspnoea, Eye swelling, Hypertension
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth swelling, Swelling face, Swollen tongue, Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Medium
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient stated that swelling did not start immediately but several days later; said it felt that it had "balled up". Also, stated that she felt more fatigued than normal.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: His arm is still sore, mostly when he raises it above his head in comparison to the arm that he did not receive the vaccine in.  He does use a wheelchair and this soreness has not limited his mobility day to day.  He may follow up with his primary doctor to see if a steroid would be appropriate.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: patient is able to move arm. only complaint is redness and some itchiness. will be taking zyrtec once daily
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Confusional state, Dizziness, Dysphagia, Fatigue
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: additional vaccines received at same time:  heplisav b-- rx  lot 945662, left arm fluzone trivalent-- rx  lot UT8488KA, left arm
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Hypotension, Lethargy, Nausea, Throat tightness, Visual impairment
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: additional vaccines received at same time:  heplisav b-- rx  lot 945662, left arm fluzone trivalent-- rx  lot UT8488KA, left arm
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient next day 11/15 had a lot of swelling in the arm and down the arm, was warm to the touch, red, and severely itchy. She said she was able to withstand the itching. It took about a week for the swelling and redness to go down. She said she continued to have itching for about 3 months after the vaccine. I called Dr.  they said they do not recommend the second dose at this time.The patient has been differed to speak to provider going forward and Dr. will notate as well.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Medium
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: muscle pain and joint pain in the left arm, Other Vaccines:  VaccineTypeBrand: covid 19 comirnaty; Manufacturer: pfizer; LotNumber: lm2221; Route: intramuscularly; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient scheduled on 12/17/25 for 12mo WCC. Provider ordered vaccines via . RN pulled the wrong dose from vaccine stock, went to document unable to locate lot number in. Had PCP,  verify it was correct, and attending Dr. Both verified correct. Nurse administered the vaccine. Patient received 1.0ml vs 0.5ml on 2/17/25 @ 6:18p, PM made aware of error 2/18/25 1715, Provider and family notified of error 12/20/2025. Provider called family with PM present on 12/20/25 @ 1334
Age: 55.0
Sex: M
Vaccine: CHIK
Symptoms: Abdominal pain, Chills, Dyspnoea, Fatigue, Nausea
Clinical narrative: 102 fever per patient, severe abdominal cramping that persisted for 4-5 days, nausea, chills, significant fatigue, difficulty breathing, congestion. Contemplated ER for difficulty breathing and decided to "ride it out". Was out of town and emergently came home.
Age: 55.0
Sex: M
Vaccine: CHIK
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: 102 fever per patient, severe abdominal cramping that persisted for 4-5 days, nausea, chills, significant fatigue, difficulty breathing, congestion. Contemplated ER for difficulty breathing and decided to "ride it out". Was out of town and emergently came home.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, IPV, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt given Kinrix and IPOL instead of intended Dtap and IPOL. No adverse effects or symptoms noted.
Age: 55.0
Sex: M
Vaccine: PNC20
Symptoms: Blister, Burning sensation, Rash, Rash erythematous, Skin lesion
Clinical narrative: Patient was awakened by burning discomfort on L hand overnight on the evening after receiving the vaccination. He developed a blistering rash on L palm that was somewhat painful. He likened it to when he had shingles years ago. He did not seek medical evaluation at the time but reported it to his providers later. The blisters resolved and the pain has also resolved but as of 2/21/25 he has a persistent L palmar rash with clustered flat erythematous lesions across multiple dermatomes which was examined and photographed by this clinician on 2/21/25 .
Age: 55.0
Sex: M
Vaccine: PNC20
Symptoms: Treponema test
Clinical narrative: Patient was awakened by burning discomfort on L hand overnight on the evening after receiving the vaccination. He developed a blistering rash on L palm that was somewhat painful. He likened it to when he had shingles years ago. He did not seek medical evaluation at the time but reported it to his providers later. The blisters resolved and the pain has also resolved but as of 2/21/25 he has a persistent L palmar rash with clustered flat erythematous lesions across multiple dermatomes which was examined and photographed by this clinician on 2/21/25 .
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: My feet are hurting they feel like pins and needles and numbness
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Pain, Posture abnormal, Sleep disorder
Clinical narrative: Below it the information from the nurse that administered the vaccine.  I saw Pt on 2/19/25, this was when I was made aware of adverse reaction from vaccine                                                                                                                                                                                                                        RN (Registered Nurse) ? Encounter Date: 2/3/2025 ? Signed  is a 71 y.o. male who presents to the  2/3/2025 for immunization(s) ordered by provider . Immunizations administered:       Pneumococcal conjugate (PCV20) (Prevnar 20) polysaccharide CRM197, adjuvant, PF 6 WKS+ IM (90677) (216) See Immunization activity for required documentation. Post-treatment monitoring done per protocol. Patient observed for adverse reactions for 15 minutes. Adverse reaction(s): None                                                                                                                                                                                                                                                              On 2/19/25 , Pt reported the following......                                                                                                                                                                                          During shot felt it in his fingertips Worst symptoms 3-4 days after injection - states he couldn't actively lift left harm. Currently with arm hanging at his side feels an abnormality in upper left arm When he actively abducts left arm localized pain increases. States it is still painful to put coat on. States he is still uncomfortable when trying to sleep on left side No bruising or rash in the area at time or after injection                                                                                                                                                                                 Pt had pain with active abduction of left arm on exam 2/19/25, no anatomical abnormalities noted.  Ultrasound of area ordered and conservative treatment with Tylenol and heat/ice recommended.   No additional follow up at this time to report.
Age: 48.0
Sex: F
Vaccine: PNC21
Symptoms: Asthenia, Chills, Dizziness, Erythema, Headache
Clinical narrative: PATIENT PRESENTED TWO DAYS AFTER THE VACCINE SAYING THAT HER ARM WAS VERY SORE AND WAS RED IN APPEARANCE. PATIENT SAID FRIDAY EVENING (TWO DAYS AFTER THE VACCINE) PATIENT HAD CHILLS, FEVER, WEAKNESS, DIZZINESS, SWEATING AND HEADACHES. PATIENT TRIED TYLENOL AND CANNOT TAKE IBUPROFEN.
Age: 48.0
Sex: F
Vaccine: PNC21
Symptoms: Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: PATIENT PRESENTED TWO DAYS AFTER THE VACCINE SAYING THAT HER ARM WAS VERY SORE AND WAS RED IN APPEARANCE. PATIENT SAID FRIDAY EVENING (TWO DAYS AFTER THE VACCINE) PATIENT HAD CHILLS, FEVER, WEAKNESS, DIZZINESS, SWEATING AND HEADACHES. PATIENT TRIED TYLENOL AND CANNOT TAKE IBUPROFEN.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: TDAP Duplication Vaccine given 8/9/2024 and 2/21/2025. Vaccine given out of CDC recommended guidelines. Patient is not experiencing any adverse effects.