chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: pain at injection site; redness at the injection site; has pain when moving the arm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis.   On 13-JUN-2025, the patient received Twinrix (intramuscular use, left arm) 1 ml. In JUN-2025, an unknown time after receiving Twinrix, the patient experienced injection site pain (Verbatim: pain at injection site), injection site erythema (Verbatim: redness at the injection site) and pain in arm (Verbatim: has pain when moving the arm). The outcome of the injection site pain, injection site erythema and pain in arm were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and pain in arm to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain, injection site erythema and pain in arm to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   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-JUN-2025 The reporter was a healthcare professional. She reported on June 20th 2025 an adverse event for Twinrix vaccine. She reported that a male patient received a Twinrix vaccine at their pharmacy on June 13th, 2025. The vaccine was administered in the left arm.  The patient contacted the pharmacy twice and reported an adverse event of pain at the injection site, (pain).  The patient reported he had pain when moving the arm (painful when moving).  The patient reported to healthcare professional that the redness at the injection site and stated it was the size of a dime. The healthcare professional reported that after a week the patient was still experienced these events and have not improved. No additional medical history or medications information were provided.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient did not receive the shot; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (first dose on 31st March 2025, batch number 3X937, expiry date 31st December 2025).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: The patient did not receive the shot). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2025 A pharmacist called to informed of a patient that had missed the second dose of Engerix-B.  She informed that the patient had the first dose in March 2025 and according to schedule the second one was supposed to be in April 2025.  The patient did not receive the shot and went to the pharmacy until June 2025.  The pharmacist wanted to know how to proceed in order to complete the doses of the vaccine schedule. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: they have a patient that may have been given a Shingrix vaccine that was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (expiry date SEP-2023) for prophylaxis.   In DEC-2023, the patient received Shingrix. In DEC-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: they have a patient that may have been given a Shingrix vaccine that was expired). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 20-JUN-2025 Practice Manager reported that they had a patient that might had been given a Shingrix vaccine that was expired which led to expired vaccine used.
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Pyrexia, Urticaria
Clinical narrative: Articular pain seven days after, fever eight dats after, and urticaria 11 days after. I had dengue on February, 2024, don t know the serotype.
Age: 0.4
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Cough, Infant irritability, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: 4/23/25 Received first dose of vaccines below. 4/30/25 Reported cough + fussiness since receiving vaccines. 6/25/25 Received second dose of vaccines listed below. 6/26/25 Reports vomiting, fever, and fussiness that started directly after receiving vaccines.
Age: 0.4
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative, Streptococcus test negative, Vomiting
Clinical narrative: 4/23/25 Received first dose of vaccines below. 4/30/25 Reported cough + fussiness since receiving vaccines. 6/25/25 Received second dose of vaccines listed below. 6/26/25 Reports vomiting, fever, and fussiness that started directly after receiving vaccines.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Right deltoid cellulitis. tx: Bactrim DS 800mg - 160mg BID x5 days.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix; Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number PJ353) for prophylaxis.   On 19-JUN-2025, the patient received Shingrix. On 19-JUN-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix) and inappropriate dose of vaccine administered (Verbatim: Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 20-JUN-2025 The healthcare professional reported that a Shingrix vaccine was reconstituted with a diluent from an MMR vaccine instead of the adjuvant that comes with Shingrix which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The final product was administered to the patient.
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; This non-serious case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a adult patient who received Men ACWY-CRM NVS (Menveo) (expiry date 31-MAR-2025) for prophylaxis.   On 01-APR-2025, the patient received Menveo (unknown arm). On 01-APR-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administration of expired vaccine). On 01-APR-2025, the outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 23-JUN-2025 The reporter reported that the patient was administered the Menveo vaccine one day after expiration which led to expired vaccine used.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Two days after I had my first vaccine, I got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Two days after I had my first vaccine, I got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a consumer via interactive digital media. Two days after the patient had his/her Shingles vaccine, he/she got shingles.
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: very sick for about a day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: very sick for about a day). The outcome of the sickness was resolved (duration 1 day).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that both Shingrix shots kicked butt. The reporter was very sick for about a day. But shingles was way worse.
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: The second shot hurt like/ well just say it hurt, but rather that than shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 (Verbatim: The second shot hurt like/ well just say it hurt, but rather that than shingles). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a consumer via interactive digital media. The second shot hurt like well, just said it hurt, but rather that than shingles.
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: I still have severe pain in my arm that I got the vaccines; 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 RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: I still have severe pain in my arm that I got the vaccines). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 21-JUN-2025 This case was reported by a patient via interactive digital media. Patient had severe pain in his/her arm that he/she got the vaccines.
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling; Injection site erythema; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Injection site swelling) and injection site erythema (Verbatim: Injection site erythema). The outcome of the injection site swelling and injection site erythema were not reported.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that after 1st dose of Shingrix the patient had redness and swelling at injection site.
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: How long will the fever last with the shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: How long will the fever last with the shingles vaccine). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:11-JUN-2025 This case was reported by a consumer via interactive digital media. The reporter asked that how long would the fever last with the shingles vaccine.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I never got my second shot. Am I protected at all; 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 did not receive Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after not receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I never got my second shot. Am I protected at all). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 11-JUN-2025 This case was reported by a consumer via interactive digital media. The patient never got his/her second shot and asked he/she was protected at all. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling; Arm pain 7/10; Mobility decreased; This non-serious case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 59-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis.   On 02-JUN-2025, the patient received Boostrix. In JUN-2025, less than 3 weeks after receiving Boostrix, the patient experienced swelling arm (Verbatim: Arm swelling), pain in arm (Verbatim: Arm pain 7/10) and mobility decreased (Verbatim: Mobility decreased). The outcome of the swelling arm, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the swelling arm, pain in arm and mobility decreased to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the swelling arm, pain in arm and mobility decreased to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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: 17-JUN-2025 GlaxoSmithKline Account Manager did not provide any vaccination date and no patient demographics at all and only provided lot number (no other vaccine detail). Account Manager requested a call back to the Practice Manager. Once the call back was successful, the Practice Manager confirmed all the vaccination date, vaccine detail and patient demographics. No Medical Information question or concern arise in this call back.; Sender's Comments:  US-GSK-US2025075891:same reporter /different patient US-GSK-US2025075891:same reporter /different patient
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: A 2-year-old patient received an adult dose of Engerix-B; A 2-year-old patient received an adult dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-year-old female patient who received HBV (Engerix B adult) (batch number 4BX39, expiry date 29-JUL-2027) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on an unknown date) and Engerix B (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: A 2-year-old patient received an adult dose of Engerix-B) and overdose (Verbatim: A 2-year-old patient received an adult dose of Engerix-B). The outcome of the adult product administered to child and overdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-JUN-2025 The medical assistant called to reported that they administered an adult dose of Engerix-B to a patient who was 2 years old which led to, adult product administered to child and overdose. The reporter mentioned that this was the 3rd dose of Engerix-B that the patient had received. The reporter had a questioned what was next steps to follow.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 36-year-old male patient who received HAV (Havrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 23-JUN-2025, the patient received the 2nd dose of Havrix. On 23-JUN-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). The outcome of the drug dose administration interval too short was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JUN-2025 The reporter calling because a patient was given a vaccine (Havrix) too early. The vaccine administration facility was the same as primary reporter. During the call, the healthcare professional informed that this was about Havrix. The patient received the 1st dose on 21st May 2025 and then the 2nd dose on 23rd June 2025 which led to shortening of vaccination schedule.
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix plus Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 18-month-old female patient who received HAV (Havrix) (batch number 42DM9, expiry date 22-JAN-2027) for prophylaxis.   On 18-JUN-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix plus Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-JUN-2025 Pharmacist called to verify if doses of vaccines that have been exposed to low temperatures should be repeated. Havrix Temperature 26.5 degree Fahrenheit which led to incorrect storage of drug. This case has been linked to US2025079380 reported by the same reporter.; Sender's Comments:  US-GSK-US2025079380:Same reporter different patient
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Menveo plus Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 57H54, expiry date 31-JAN-2026) for prophylaxis.   On 20-JUN-2025 13:10, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo plus Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK receipt date: 24-JUN-2025 Pharmacist called to verify if doses of vaccines that have been exposed to low temperatures should be repeated and Menveo (1 vial) Temperature was 26.5 degree Fahrenheit stored and received on 20th June 2025 which led to incorrect storage of drug. This is the 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2025079375:Same reporter different patient US-GSK-US2025079376:Same reporter different patient US-GSK-US2025079378:Same reporter different patient GSK-US2025079384:Same reporter different patient US-GSK-US2025079387:Same reporter different patient
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: autoimmune disease: myasthenia gravis; This is a spontaneous report received from a Consumer or other non HCP.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunisation. The following information was reported: MYASTHENIA GRAVIS (caused and prolonged hospitalization, disability, medically significant) with onset 16Jan2022, outcome "not recovered", described as "autoimmune disease: myasthenia gravis". Soon after the booster shot, patient started feeling symptoms of her autoimmune disease myasthenia gravis. She was never even sick before she got the vaccines The patient was hospitalized and prolonged hospitalization for myasthenia gravis (hospitalization duration: 3 day(s)). Therapeutic measures were taken as a result of myasthenia gravis (prescription for myasthenia gravis).  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: patient administered a dose of YF-VAX intramuscularly with no reported AE; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was administered a dose of yellowfever vaccine-[YF-VAX] intramuscularly with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jun-2025, the patient received a dose of 0.5 ml of suspect yellowfever vaccine- intramuscularly (formulation: Solution for injection) (lot UK134AA, strength: standard and frequency: once, expiry date: 30-Nov-2025) via intramuscular route in the right deltoid for immunization with no reported adverse event (incorrect route of product administration) (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: 29.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was supposed to receive MMRII & Varivax instead of Proquad, patient tolerated vaccine well no allergy or adverse reaction to injection was noted, patient was advised by doctor to watch area for any reaction.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: I could barely use my right arm for the first two days, it ached and throbbed. Now, three weeks later, I am in extreme pain when using this arm and cannot do things with this arm that were daily and routine without pain. It wakes me up at night due to the pain.
Age: 45.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site rash
Clinical narrative: 2 weeks after being administered vaccines, patient experienced a rash on the left arm where Menveo was administered
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Cold sweat, Decreased appetite, Dizziness, Erythema, Fatigue
Clinical narrative: Arm swelling, redness and hot to touch, pt had a fever of about 102 for about 30 hours, body aches and cold sweats, flu like symptoms, light headedness, fatigue, no appetite. Pt has been taking benadryl and tylenol.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Arm swelling, redness and hot to touch, pt had a fever of about 102 for about 30 hours, body aches and cold sweats, flu like symptoms, light headedness, fatigue, no appetite. Pt has been taking benadryl and tylenol.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Colitis, Colonoscopy abnormal, Dehydration, Diarrhoea
Clinical narrative: three weeks of unrelenting diarrhea, resulting in severe dehydration, and colonoscopy that revealed acute attack of colitis
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Wrong patient
Clinical narrative: Given Proquad  and Kinrix in error,was supposed for siter
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient received a pedi dose instead of adult
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Colonoscopy abnormal, Diarrhoea
Clinical narrative: relentless diarrhea x 3 weeks
Age: 0.5
Sex: M
Vaccine: HPV9, RV1, HPV9, RV5
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Wrong patient received product
Clinical narrative: HPV vaccine that was meant for 12 year old son was given to 6 month old baby. Currently running a slight fever. Shot administered around 9:45am fever began around 10:35am.
Age: 0.5
Sex: M
Vaccine: HPV9, RV1, HPV9, RV5
Symptoms: No adverse event, Vaccination error
Clinical narrative: HPV vaccine that was meant for 12 year old son was given to 6 month old baby. Currently running a slight fever. Shot administered around 9:45am fever began around 10:35am.
Age: 0.5
Sex: M
Vaccine: HPV9, RV1, HPV9, RV5
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Wrong patient received product
Clinical narrative: HPV vaccine given in Error, no adverse events at the time of adminstration.
Age: 0.5
Sex: M
Vaccine: HPV9, RV1, HPV9, RV5
Symptoms: No adverse event, Vaccination error
Clinical narrative: HPV vaccine given in Error, no adverse events at the time of adminstration.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Adult dose given instead of Pediatric dose in error.
Age: 11.0
Sex: F
Vaccine: IPV, MMR, MNQ
Symptoms: Pain, Swelling face, Tenderness
Clinical narrative: pt. has swelling to right side of face. Performed by Family Medicine Right facial swelling MMR given June 5, facial swelling presented 24 days later. Asymmetrical "mumps presentation" Painful while chewing. Painful to touch. No redness, no warmth, no fever. Per patients mother, the swelling has gone down since the initial occurrence. Will get an xray to rule out any abnormalities. Adverse effect of vaccine, initial encounter Unknown if vaccine reaction has occurred. MMR given June 5, facial swelling presented 24 days later. Painful while chewing. Painful to touch. No redness, no warmth, no fever. No lymph involvement Per patients mother, the swelling has gone down since the initial occurrence. Using ibuprofen for pain.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered expired dose (exp 6/30/25. Patient received vaccinations in preparation for travel (High-dose Fluzone, TDap, Typhoid, Hep A/B, Moderna COVID 24/25) with no incidence our adverse outcome.
Age: 71.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Abdominal pain, Blister, Dizziness, Dysphagia, Fatigue
Clinical narrative: Patient received Tdap (right) and pneumonia (left) vaccine on 06.25.25, on  Friday she started with localized pruritus bilaterally. Saturday with appearance of 4-6 0.5cm clear vessicles on the ventral surface of the left arm, located between the deltoid area and the lateral epicondyl, with associated symptoms of  bilateral mild erythema and induratio, limited to ventral surface of bilateral upper arms. Patient  pain, mouth ulcers, fever, headache, dizziness, peeling skin, fatigue, dysphagia, abdominal pain, or edema. She has had vaccines in the past, with no adverse response and has no known allergies. Left arm with around 6 clear, non-purulent vesicles, each approximately 0.5 cm, non-tender on the ventral surface, in the deltoid area; Bilateral skin is erythematous, blanchable, with mild induration confined to ventral upper aspect of the arm between the lower deltoid and lateral epicondyle area No signs of local infection, no mucosal involvement, no systemic symptoms. Findings consistent with delayed hypersensitivity reaction to vaccine, will treat with prednisone, cetirizine, and 1% hydrocortisone with follow-up in 3-days for improvement.
Age: 71.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site reaction, Mouth ulceration
Clinical narrative: Patient received Tdap (right) and pneumonia (left) vaccine on 06.25.25, on  Friday she started with localized pruritus bilaterally. Saturday with appearance of 4-6 0.5cm clear vessicles on the ventral surface of the left arm, located between the deltoid area and the lateral epicondyl, with associated symptoms of  bilateral mild erythema and induratio, limited to ventral surface of bilateral upper arms. Patient  pain, mouth ulcers, fever, headache, dizziness, peeling skin, fatigue, dysphagia, abdominal pain, or edema. She has had vaccines in the past, with no adverse response and has no known allergies. Left arm with around 6 clear, non-purulent vesicles, each approximately 0.5 cm, non-tender on the ventral surface, in the deltoid area; Bilateral skin is erythematous, blanchable, with mild induration confined to ventral upper aspect of the arm between the lower deltoid and lateral epicondyle area No signs of local infection, no mucosal involvement, no systemic symptoms. Findings consistent with delayed hypersensitivity reaction to vaccine, will treat with prednisone, cetirizine, and 1% hydrocortisone with follow-up in 3-days for improvement.
Age: 71.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Oedema, Pain, Pruritus, Pyrexia, Skin exfoliation
Clinical narrative: Patient received Tdap (right) and pneumonia (left) vaccine on 06.25.25, on  Friday she started with localized pruritus bilaterally. Saturday with appearance of 4-6 0.5cm clear vessicles on the ventral surface of the left arm, located between the deltoid area and the lateral epicondyl, with associated symptoms of  bilateral mild erythema and induratio, limited to ventral surface of bilateral upper arms. Patient  pain, mouth ulcers, fever, headache, dizziness, peeling skin, fatigue, dysphagia, abdominal pain, or edema. She has had vaccines in the past, with no adverse response and has no known allergies. Left arm with around 6 clear, non-purulent vesicles, each approximately 0.5 cm, non-tender on the ventral surface, in the deltoid area; Bilateral skin is erythematous, blanchable, with mild induration confined to ventral upper aspect of the arm between the lower deltoid and lateral epicondyle area No signs of local infection, no mucosal involvement, no systemic symptoms. Findings consistent with delayed hypersensitivity reaction to vaccine, will treat with prednisone, cetirizine, and 1% hydrocortisone with follow-up in 3-days for improvement.
Age: 65.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: PT reported tingling and nerve pain radiating from clavicle to elbow. Spontaneous onset and rapid and lasts for a few seconds. PT reported this during the third dose of Twinrix. PT has also reported to doctor and may be seen by specialist to look into this issue. Counseled to journal and  water and food and sleep to spot triggers.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given the HPV vaccine a month to early. no symptoms or reactions after given vaccine. Vaccine will be considered an invalid dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: THE PATIENT WAS GIVEN ZOSTER #3 SHE DIDN'T NEED IT
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Joint stiffness, Muscle tightness, Myalgia
Clinical narrative: patient stated she has 4 blisters on the side of her face that are oozing clear liquid that started today (2 days after vaccination) also states had low grade fever yesterday and has muscle soreness/ tightness in her left shoulder blade and the left side of her neck that started yesterday (1 day after vaccination) patient will be calling prescriber to rule out other causes besides reaction to the vaccine
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: patient stated she has 4 blisters on the side of her face that are oozing clear liquid that started today (2 days after vaccination) also states had low grade fever yesterday and has muscle soreness/ tightness in her left shoulder blade and the left side of her neck that started yesterday (1 day after vaccination) patient will be calling prescriber to rule out other causes besides reaction to the vaccine
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Erythema, Lymphadenitis
Clinical narrative: Red mark on left arm is still present many weeks after injection. Looks/feels like a sunburn. Lymph nodes in keft armpit and breast have been very inflamed, and my blood sugar has not been going down at night as it should, requiring a lot of extra medication.
Sex: M
Vaccine: RSV
Symptoms: Tremor
Clinical narrative: He started with shaking in one of his legs 2 weeks after the injection and then it became both legs. It then turned into arm shaking with the legs and then also chin tremors and head shaking. His leg and arm tremors subsided about 8-9 weeks after injection. He still has some chin tremors and head tremors.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Muscular weakness, Pain in extremity, Tremor
Clinical narrative: dizziness; shaking, soreness and weakness in left arm an hour after administration
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Had vaccine expiration date checked by colleague, I did not double check.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Nil
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Medical staff administered a SpikeVax vaccine to a 10 year old child.  Medical staff was unaware of the age recommendations for the SpikeVax.  Child left facility without incident.  Provider followed up and child was stated to be in fine health still.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Nil
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Nil
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered to the patient.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Electrocardiogram ambulatory, Headache, Laboratory test
Clinical narrative: dizziness, pots, worsening seizures and headaches, migraines
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Postural orthostatic tachycardia syndrome, Seizure
Clinical narrative: dizziness, pots, worsening seizures and headaches, migraines
Age: 26.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: heplisav-B was given SQ in error. pt at the time reported no symptoms
Age: 1.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMRV, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix given out of order and MMRV given as first dose instead of MMR and Varicella separately. Pt reported no adverse events. Error was noticed on 7/1/25 when pt returned to clinic for next shot in series.
Age: 1.92
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix given when pt should have received Infanrix.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: reaction started within 8 hrs of adm.  started with severe h/a and nausea.  next day, Thursday h/a cont with n/d, no vomiting.  this cont until Saturday and sx resolved.  no further c/o.  pt did not have any local reaction at adm site.  pt has not had a vaccine reaction in the past.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Patient aware of error not adverse events noted at this time
Age: 56.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pustule, Rash
Clinical narrative: Pt states rash with pustules on face 2days later
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Expired product administered
Clinical narrative: when I put the vaccine into the system I realized it expired 6/30/25.  I notified Clinic Coordinator ASAP and mom was contacted to notify her that expired vaccine was given and review recommendation to repeat the dose as the expired dose will not count.  She had questions about whether child would have any untoward side effects - reviewed that the expired vaccine should not cause anything outside of a normal vaccine response, that the concern with giving an expired vaccine is efficacy past the expiry date.  Reviewed common vaccine side effects and management of them.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Patient was given a vaccine with the Pentacel diluent was mixed with the MMRV powder
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Back pain, Impaired driving ability, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: She reports experiencing pain in her right shoulder, which she describes as severe and debilitating. The pain is so intense that it restricts her mobility, making daily activities such as showering and driving extremely difficult. She also mentions a sharp, shooting pain that radiates down her entire arm to her forearm, past her elbow, and into her back. She has not noticed any swelling, redness, numbness, or tingling in the area. She has been managing the pain with ibuprofen and Tylenol for the past week, along with the application of heat and IcyHot, but these measures have not provided relief. She received a meningitis B vaccine (Bexsero) 7 days ago. This was the second (and final dose). She has never had any other experiences like this with a vaccine. No fevers. Right shoulder pain with limited range of motion of the right upper extremity. There is point tenderness of the posterior (over the superior angle of the scapular) shoulder. She has pain moving the right arm up to 90 degrees and is unable to fully raise her arm over her head. The pain radiates down the arm past the elbow to the forearm. No redness or swelling or subjective warmth is noted. She describes the pain elicited as sharp and shooting. Determined this is acute right shoulder pain after meningococcal vaccine - Likely result of meningitis B vaccine administered on 06/24/2025 - Pain not improved with ibuprofen, Tylenol, heat, or IcyHot - Prescription for meloxicam 15 mg provided; take half a tablet (7.5 mg) once daily, can increase to twice daily if necessary - Follow regimen for a maximum of one week - Referral to consultant for further evaluation - Advised to call if worsening pain; consider oral or intra-articular steroid injection if there's no improvement but I'd like to see what hand or orthopedic surgery would think
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Pain in extremity
Clinical narrative: She reports experiencing pain in her right shoulder, which she describes as severe and debilitating. The pain is so intense that it restricts her mobility, making daily activities such as showering and driving extremely difficult. She also mentions a sharp, shooting pain that radiates down her entire arm to her forearm, past her elbow, and into her back. She has not noticed any swelling, redness, numbness, or tingling in the area. She has been managing the pain with ibuprofen and Tylenol for the past week, along with the application of heat and IcyHot, but these measures have not provided relief. She received a meningitis B vaccine (Bexsero) 7 days ago. This was the second (and final dose). She has never had any other experiences like this with a vaccine. No fevers. Right shoulder pain with limited range of motion of the right upper extremity. There is point tenderness of the posterior (over the superior angle of the scapular) shoulder. She has pain moving the right arm up to 90 degrees and is unable to fully raise her arm over her head. The pain radiates down the arm past the elbow to the forearm. No redness or swelling or subjective warmth is noted. She describes the pain elicited as sharp and shooting. Determined this is acute right shoulder pain after meningococcal vaccine - Likely result of meningitis B vaccine administered on 06/24/2025 - Pain not improved with ibuprofen, Tylenol, heat, or IcyHot - Prescription for meloxicam 15 mg provided; take half a tablet (7.5 mg) once daily, can increase to twice daily if necessary - Follow regimen for a maximum of one week - Referral to consultant for further evaluation - Advised to call if worsening pain; consider oral or intra-articular steroid injection if there's no improvement but I'd like to see what hand or orthopedic surgery would think
Age: 18.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient received the wrong vaccine by the Medical Assistant. Provider ordered patient to receive the HPV vaccine. Instead, the Medical Assistant prepared and administered the PCV vaccine to patient.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: THERE WAS NO ADVERSE EVENT; HOWEVER, AN EXPIRED VACCINE WAS GIVEN TO THE PATIENT
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Pt developed blood in stool within 2 days after receiving first rotavirus vaccine
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Immediate post-injection reaction, Mobility decreased, Myalgia, Pain
Clinical narrative: Patient sent message with below complaint of vaccine concern, "I am still having pain from the shot last Monday. My shoulder is painful with zero activity. I have limited mobility. Ie: hurts to raise arms to get dressed and resonates done my arm. The shot was very high and very painful when administered. I waited a week to see if it was just muscle pain but something is not right. "     Recommendation from physician "Spoke with patient, she reports vaccine administration was very high up on her arm and she had immediate pain, has not improved in >1 week, pain with any overhead movement.  Located at top of shoulder radiating to bicep.  Suspect vaccine induced tendonitis, recommend ice and medrol pack to reduce inflammation, will send in.  Will check in after 1 week."
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient sent message with below complaint of vaccine concern, "I am still having pain from the shot last Monday. My shoulder is painful with zero activity. I have limited mobility. Ie: hurts to raise arms to get dressed and resonates done my arm. The shot was very high and very painful when administered. I waited a week to see if it was just muscle pain but something is not right. "     Recommendation from physician "Spoke with patient, she reports vaccine administration was very high up on her arm and she had immediate pain, has not improved in >1 week, pain with any overhead movement.  Located at top of shoulder radiating to bicep.  Suspect vaccine induced tendonitis, recommend ice and medrol pack to reduce inflammation, will send in.  Will check in after 1 week."
Age: 1.5
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PATIENT WAS GIVEN THE WRONG VACCINE IT SHOULD HAVE BEEN Dtap  INSTEAD OF Tdap, we did notified mom and if she had any concerns to bring him in to the clinic
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Adverse reaction, Underdose
Clinical narrative: Patient was given pediactric dose instead of aldult dose. Patient didn't have any adverse reaction at the time vaccine was given. He waited 15 minutes after administration. Patient was contacted 07/01/25 @ 2:30 pm and he verified he wasn't having any adverse reactions.  He stated he was feeling well.
Age: 24.0
Sex: M
Vaccine: ADEN_4_7, FLU3, HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Blood culture negative, Cough, Cutaneous vasculitis, Pyrexia, Rash
Clinical narrative: Patient has what appears to be a leukocytoclastic vasculitis type rash.  The etiology is unclear at this time.  He had associated fever; now resolved.  Blood cultures reveal no growth to date.  He received multiple vaccines on 5/21/2025 and 5/27/2025.  He has had a cough for the past 6 or 7 weeks.  This rash could represent a vaccine reaction or signs/symptoms from a viral syndrome.  He appears to be improving off antibiotic therapy.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: I have dismissed this for years because I did not want to admit it could be possible.  When I first started bringing it up to healthcare providers it was kind of dismissed.  I have not even discussed it with my current provider.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Chest discomfort
Clinical narrative: About 10 minutes after receiving first dose of this vaccine student developed chest pressure, lasting about 8 minutes and resolved on its own. Denies shortness of breath, diaphoresis, rash, dizziness, nausea/vomiting or LOC.