chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Chest X-ray normal, Crying, Influenza A virus test negative, Influenza B virus test negative, Respiratory syncytial virus test negative
Clinical narrative: Patient became inconsolable 4+ hours after vaccinations. Patient was seen at ER for this.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Patient became inconsolable 4+ hours after vaccinations. Patient was seen at ER for this.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was accidentally administered an expired dose of Engerix-B (29 days after listed expiration). Patient was notified immediately of event and advised to let us know of any issues. Pharmacy contacted CDC and GSK Pharmaceuticals for guidance. Per CDC, as a non-live vaccine it is recommended to repeat the dose as soon as possible as it is considered invalid and patient may then resume series as scheduled. GSK pharmaceuticals stated they have not evaluated the immunogenicity or safety following an administration of an expired vaccine and does not make any recommendations regarding revaccination. However, results from in-house analytical potency testing have shown that the vaccine remains within the approved specifications for up to 30 days following the expiration date. Patient was informed of these findings and stated that she would like to repeat the dose per CDC recommendations. No reports of any adverse reactions following administration of expired dose.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Diarrhoea, Diet refusal, Faeces discoloured, Irritability, Retching
Clinical narrative: Patient being seen at clinic today for diarrhea and vomiting. Mom states patient is refusing to eat as he normally does, gagging frequently during bottles, and has only had a total of 9 ounces today. (Was able to drink another 2 oz in clinic)  Patient started the Gerber stage 2 juices either Sunday or Monday and seemed to be doing well getting 1 ounce per day. No juice given today.  Vomiting occurred yesterday before eating, no emesis after; no cough preceding emesis. No vomiting today. One episode of diarrhea today- green and watery. No juice today.   Had 4m vaccines on Monday. No rxn after first set at 2m other than some increased fussiness. Did not swallow entire rotavirus dose at 2m, but did this time, so Mom is wondering if it could be related to the full dose of the Rotavirus vaccine.  Has had 3 or 4 good wet diapers today, which less than normal.  Mom denies fevers, cough, congestion, runny nose, and fatigue. Patient has had no known sick exposures.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC15, RV5
Symptoms: Vomiting
Clinical narrative: Patient being seen at clinic today for diarrhea and vomiting. Mom states patient is refusing to eat as he normally does, gagging frequently during bottles, and has only had a total of 9 ounces today. (Was able to drink another 2 oz in clinic)  Patient started the Gerber stage 2 juices either Sunday or Monday and seemed to be doing well getting 1 ounce per day. No juice given today.  Vomiting occurred yesterday before eating, no emesis after; no cough preceding emesis. No vomiting today. One episode of diarrhea today- green and watery. No juice today.   Had 4m vaccines on Monday. No rxn after first set at 2m other than some increased fussiness. Did not swallow entire rotavirus dose at 2m, but did this time, so Mom is wondering if it could be related to the full dose of the Rotavirus vaccine.  Has had 3 or 4 good wet diapers today, which less than normal.  Mom denies fevers, cough, congestion, runny nose, and fatigue. Patient has had no known sick exposures.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Associate was given a Hep B vaccine on 6/10/25 and another on 6/12/25, notified patient and pharmacist, associate reports no adverse reaction or symptoms
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired SARS-CoV-2 (COVID-19) 50 mcg/0.5 mL preservative-free vaccine administered to patient who qualified for booster dose. Vaccine expired on JUN 9, 2025, subsequently administered on JUN 11, 2025. Patient notified on JUN 11, 2025. Patient has been educated to report any adverse drug reactions following vaccine administration. No adverse drug reactions have been reported by patient. No further visits or hospitalization needed post administration of expired vaccine.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Chest pain, Dizziness, Syncope
Clinical narrative: Patient felt dizzy with s chest pain and collapsed on the floor, 911 was called and transfered to ER
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Syncope
Clinical narrative: syncopal episode with fall
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion induced, Exposure during pregnancy, Foetal hypokinesia, Magnetic resonance imaging abnormal
Clinical narrative: On March 19, 2021, I receive the Janssen vaccine. On March 21, I felt fetal movement declining. A fetal MR scan using multiple single slice fast spin-echo T2-weighted images of the brain, along with coronal T1 and axial diffusion techniques was performed on March 23, 2021, and read on March 24, 2021. The reading indicated sequela of germinal matrix hemorrhaging; one prior and one present. It all happened so fast, but the doctors at hospital informed us that the baby would not have a strong chance of surviving, and if she survived, would have a very difficult and short life. The pregnancy was terminated at hospital on March 27, 2021.
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Erythema, Pain in extremity, Skin infection, Skin warm
Clinical narrative: Per Provider's documentation regarding office visit on  6/13/25: ("Cellulitis of upper extremity, unspecified laterality/ Adverse effect of vaccine, initial encounter Patient reported pain, warmth, and redness in her right upper extremity that started the night prior. She states that she received two vaccinations for hepatitis and pneumonia during her annual physical on the 6/6/25, and she noticed the symptoms approximately one week later. The patient describes the affected area as feeling hot and painful, and she denies any associated fevers, chills, nausea, or vomiting.  Likely to be skin infection. Prescribed Keflex 500 mg, Take 1 capsule (500 mg total) by mouth 4 (four) times a day for 7 days. Rationale explained. Risk and benefits explained. Recommended ice application to the affected area to help with swelling.  Discussed the importance of monitoring  for fever or spreading redness; advised to contact if these symptoms occur.  Continue to monitor for improvement in symptoms.")   Follow-up with patient  6/16/25: Patient reported she doing much better since being prescribed antibiotic. No complaints at this time. No new symptoms.
Age: 59.0
Sex: F
Vaccine: PNC21
Symptoms: Swelling
Clinical narrative: Per Provider's documentation regarding office visit on  6/13/25: ("Cellulitis of upper extremity, unspecified laterality/ Adverse effect of vaccine, initial encounter Patient reported pain, warmth, and redness in her right upper extremity that started the night prior. She states that she received two vaccinations for hepatitis and pneumonia during her annual physical on the 6/6/25, and she noticed the symptoms approximately one week later. The patient describes the affected area as feeling hot and painful, and she denies any associated fevers, chills, nausea, or vomiting.  Likely to be skin infection. Prescribed Keflex 500 mg, Take 1 capsule (500 mg total) by mouth 4 (four) times a day for 7 days. Rationale explained. Risk and benefits explained. Recommended ice application to the affected area to help with swelling.  Discussed the importance of monitoring  for fever or spreading redness; advised to contact if these symptoms occur.  Continue to monitor for improvement in symptoms.")   Follow-up with patient  6/16/25: Patient reported she doing much better since being prescribed antibiotic. No complaints at this time. No new symptoms.
Age: 41.0
Sex: F
Vaccine: HPV9
Symptoms: Joint effusion, Mobility decreased, Pain in extremity, X-ray limb abnormal
Clinical narrative: started to lose movement in arm,  went to doctor who prescribed medication and had corticosteroid injection for pain . has been taking injections for 15 days no. doing physical therapy and starting pain medication. meloxicam.
Age: 59.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient. Patient notified.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Anger, Irritability, Suicidal ideation
Clinical narrative: Irritability, angry, suicidal
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: Pt became diaphoretic, light headed, pale, nauseated ,passed out 15 minutes after receiving vaccine.  Basic observation, pt return to normal, no treament needed.  Pt discahrged to home at 14.10
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Faecal occult blood positive, Haematochezia
Clinical narrative: Bloody stools, lasting ~10 days
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Patient received Menquadfi vaccine instead of Trumenba vaccine.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient given 3rd dose of Hepatitis A vaccine in error.  Patient received 1st Hep A on 3/22/2022. Patient received 2nd Hep A on 10/01/2024.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Urticaria
Clinical narrative: Acute urtucaria, given Benadryl and improved within 30min-1hour
Age: 45.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Rash
Clinical narrative: Patient developed localized rash to left arm
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: I had a fever from Tuesday 6/3- Thursday 6/5, of over 103.00. At one point my temperature was 103.6.  At the injection site my arm was red and swollen almost from shoulder to elbow, and was very sore.  I had a constant headache and body aches. I was unable to eat during this time.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: I had a fever from Tuesday 6/3- Thursday 6/5, of over 103.00. At one point my temperature was 103.6.  At the injection site my arm was red and swollen almost from shoulder to elbow, and was very sore.  I had a constant headache and body aches. I was unable to eat during this time.
Age: 84.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient had already received Prevnar 20 on11/05/2022. Patient came in with a prescription from the provider, hence the vaccine was given again.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Product administered at inappropriate site, Surgery, Tendon injury
Clinical narrative: The patient claims that he experienced pain after receiving the Novavax vaccine at our pharmacy that did not go away after a few days as expected. He went to the doctor to get evaluated and the doctor told him that his tendon has been injected through during vaccination resulting in a hole. The doctor advised that this would not heal without surgery. The patient has been in physical pain since the vaccine and decided to get the surgery. He then had to have his arm in a sling for 6 weeks post operation and is still in physical pain. He will be starting physical therapy soon to help with mobility and the pain. The patient and his wife (redacted name 06/07/19xx) received the same vaccine on the same day. Spouse (redacted name) did not experience the same pain but notes that her vaccine was also given very high on her shoulder.
Age: 74.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pharmacy received orders from clinic to administer Ipol and Infanrix on 6/4/2025. Clinic send duplicate orders in error on 6/10/25 and pharmacy administered Ipol and Infanrix to patient on 6/10/2025 as well. No adverse events yet reported from patient on 6/17/25. Clinic aware.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose of Shingrix inappropriately
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Hyperhidrosis, Myalgia, Palpitations
Clinical narrative: extreme weakness, muscle pain, palpitations, sweats resulting in hospitalization
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: No adverse events
Age: 10.0
Sex: M
Vaccine: HPV9, PPV
Symptoms: Dizziness, Lipids, Loss of consciousness, Syncope, Vomiting
Clinical narrative: Patient received HPV and PPV23.   Felt fine initially.   Then had a finger prick for a lipid panel test.  After the lipid panel was completed, pt became light headed.  Had a syncopal episode.  I was able to catch him and lower him to the ground.   Regained consciousness after a few seconds and then vomited.  Pt remained on the ground until he was feeling less light headed.  Was brought to an exam room, applied cool compresses to head/neck and given juice.  Remained in an exam room until he was feeling better.
Age: 23.0
Sex: F
Vaccine: HEPAB
Symptoms: Immediate post-injection reaction, Peripheral swelling, Skin warm
Clinical narrative: Immediately after administration in the deltoid muscle, the patient's arm got hot and was likely swelling after wards (2 minutes after administration of twinrix) . Discussed the possibility of the arthus reaction and referred to provider and monitoring, ice pack, anti-inflammatory medications and to follow up if needed.
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a dose of the Heplisav-B vaccine, when the vaccine is indicated for ages 18 years and older. The patient was 18 months at the time of the incident.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Myalgia
Clinical narrative: On 6/9/25 during a scheduled call, participant reported the following symptoms after receiving the vaccine on 6/6/25: starting on 6/6/25 pt had headache, muscle pain, "fever" (99.6F), headache, cough and shortness of breath. Pt reported symptoms being mild and they were able to continue daily activities. Pt stated that they weren't certain if SOB and coughing was related to vaccine or not. Symptoms subsided on 6/7/25. Pt states they did not seek any medical attention or take any medication for symptoms. RN advised pt to seek medical attention if needed, and pt acknowledged that they will seek treatment if needed.
Sex: F
Vaccine: MMR, MMR
Symptoms: Measles antibody, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: she was was not sufficiently vaccinated against mumps and rubella.; she was was not sufficiently vaccinated against mumps and rubella.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.   The patient's medical history and concurrent conditions were not reported. Concomitant medications included leflunomide.  On an unknown date, "in the 80's or 90's", the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection, administered for prophylaxis (dose, route of administration, anatomical location, lot # and expiration date were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported).  On an unspecified date in 2025 (reported as "recently"), the patient had measles, mumps and rubella titers drawn and it showed that she was not sufficiently vaccinated against mumps and rubella (the result of measles titer was not reported).   The outcome of the events was not reported.  Causality assessment was not provided.  Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Additional AE; HCP called to report a 47 year old female received a dose of PROQUAD, caller stated this was a first dose. No side effects or symptoms reported. No additional information provided. No Additional AE/ No PQC.; This spontaneous report was received from a nurse and refers to a 47-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 05-Jun-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 mL (lot #Y010306 and expiration date reported as 01-Dec-2025) (route of administration and vaccination site was not provided) administered for prophylaxis (product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent, solution for injection. No side effects or symptoms were reported. No additional information was provided. No Additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PEDVAX HIB was administered to 1 consumer following a temperature excursion. No additional AE reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.   On 27-May-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) (1 dosage form, lot # X007544, expiration date: 20-Nov-2025; strength, route of administration, dose number in series and anatomical site not provided) for prophylaxis. The vaccine was administered following a temperature excursion: 18.8C for 9 hours and 20 minutes (Product storage error). There was no previous temperature excursion. No additional adverse event reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: swelling in feet and ankles; feet swelling; This non-serious case was reported by a consumer via call center representative and described the occurrence of ankle swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included minimal change disease (diagnosed 10 years ago). Concomitant products included prednisone and lisinopril.   On 28-MAY-2025, the patient received the 1st dose of Shingrix. On 29-MAY-2025, 1 days after receiving Shingrix, the patient experienced ankle swelling (Verbatim: swelling in feet and ankles) and swelling of feet (Verbatim: feet swelling). The outcome of the ankle swelling and swelling of feet were not resolved.   It was unknown if the reporter considered the ankle swelling to be related to Shingrix. The reporter considered the swelling of feet to be related to Shingrix.     It was unknown if the company considered the ankle swelling to be related to Shingrix. The company considered the swelling of feet to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUN-2025 The reporter was the patient.   The patient received Shingrix vaccine and had major swelling in feet and ankles. The patient was diagnosed with Minimal Change Disease (MCD) 10 years ago.   The patient believes she had the disease for 30 years before she was diagnosed.   The patient's Minimal Change Disease presents with swollen feet and ankles, which has been under control with current medication.  When she becomes ill with a cold, or infection, she experiences swelling in feet and ankles and bottom torso.   When this happens, she would took an increased dose of prednisone which will resolve the swelling. The patient takes Prednisone 15 microgram daily and Lisinopril 5 microgram daily to treat MCD.   The patient sees a nephrologist who treats and monitors her MCD. On 28 May 2025, the patient received the first dose of Shingrix.   Within 24 hours, the patient began to experience major swelling in her feet and ankles.  Subsequently, the patient increased the Prednisone dose to 30 microgram daily to treat the swelling at the time of the call she was taking 25 microgram daily of Prednisone.  The swelling of her feet and ankles has not resolved. The patient was confident that the swollen feet was related to the Shingrix vaccine. The patient did not plan to get the second dose of Shingrix vaccine. The patient has lab work done every 3 months to monitor MCD.   Her next lab work is due in July 2025.
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 1st dose on 2019. On may 3rd, 2025 the 2nd dose of Twinrix was administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2019).   On 03-MAY-2025, the patient received the 2nd dose of Twinrix. On 03-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received the 1st dose on 2019. On may 3rd, 2025 the 2nd dose of Twinrix was administered.). The outcome of the drug dose administration interval too long 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: 10-JUN-2025 The pharmacist reported that the patient had Twinrix received the 1st dose in 2019 and on 3rd May 2025 the 2nd dose of Twinrix was administered.  The reporter asked how they treat that situation and did it count as the first or does the third dose would be in October 2025 and asked should they restart the series. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule; Sender's Comments:  US2025072143:Case created for 2nd patient
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still get shingles 3 or 4 times a year; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still get shingles 3 or 4 times a year). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the shots a few years ago and still got shingles 3 or 4 times a year, sucks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 3 weeks).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 10-JUN-2025 This case was reported by a patient via interactive digital media. A year after getting a two-part vaccine the patient still got shingles, although it was relatively mild and lasted less than three weeks. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 10-JUN-2025 This case was reported by a patient via interactive digital media. Patient got the Shingrix vaccine (2shots) and still got it.   However immediately went on med and was confined to small area with some itching.  Dermatologist gave lotion which helped the patient, and stated that yes do get the vaccine as it may keep from getting a bad case.  This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: did not feel good for 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: did not feel good for 2 days). The outcome of the feeling unwell was resolved (duration 2 days).   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2025 This case was reported by a patient via interactive digital media The patient reported that he/she got shot number one of Shingles vaccine will get the next one in August.  The patient stated he/she did not feel good for 2 days, but it was worth it.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number H97H2, expiry date 29-MAR-2027) for prophylaxis.   Previously administered products included Shingrix (patient received a first dose of Shingrix back in September 21, 2018).   On 08-APR-2025, the patient received the 2nd dose of Shingrix. On 08-APR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 10-JUN-2025 Other HCP reported that a patient received a first dose of Shingrix back in September 21, 2018 and then a second dose was given April 8, 2025, which led to drug dose administration interval too long. This case linked with US2025072149 reported by same reporter.; Sender's Comments:  US-GSK-US2025072149:case created for husband and wife
Age: 55.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A female patient had Twinrix and received the 1st dose on 2019 and On may 3rd, 2025 the 2nd dose of Twinrix was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix in 2019).   On 03-MAY-2025, the patient received the 2nd dose of Twinrix. On 03-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: A female patient had Twinrix and received the 1st dose on 2019 and On may 3rd, 2025 the 2nd dose of Twinrix was administered). The outcome of the drug dose administration interval too long 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: 10-JUN-2025 The pharmacist reported that the second patient had Twinrix and received the 1st dose in 2019. On 03 May 2025 the 2nd dose of Twinrix was administered. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2025AMR074623:case created for 2nd patient
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration in a 2 month old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5895B, expiry date 16-FEB-2026) for prophylaxis.   On 10-JUN-2025, the patient received Kinrix. On 10-JUN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration in a 2-month-old). The outcome of the inappropriate age at vaccine administration 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: 10-JUN-2025 The reporter reported that 2-month-old patient received Kinrix vaccine which led to, inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient.  Previously administered products included Shingrix (received a Shingrix vaccine 3 and 1/2 years ago in 12/2021).   The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: Never received second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 11-JUN-2025 Pharmacist reported that a male patient received a Shingrix vaccine 3 and 1/2 years ago in 12/2021. Never received second dose and patient wanted to finish series if possible. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; 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 HBV (Engerix B) (batch number XS27B, expiry date 17-MAR-2025) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-JUN-2025 The healthcare provider mentioned that a patient was given an expired Engerix-B vaccine which led to, expired vaccine used. The reporter did not mention date of administration during the call.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: No adverse effect; Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.; This spontaneous case was reported by an other health care professional and describes the occurrence of DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.) and NO ADVERSE EVENT (No adverse effect) in a 73-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3046734) for COVID-19 prophylaxis.    No Medical History information was reported.   On 12-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 12-Jun-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (Complained about the plunger of a vaccine from lot #3046734/having to push the plunger very hard while giving the vaccine to the patient.) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that HCP had to push the plunger very hard while giving the vaccine to the patient. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not reported.  The Device Problem Information include FDA code: 1670, IMDRF Code: A23, Device problem: Use of Device Problem.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2025: Live follow-up received contains non-significant information: reference number added.
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: Localized cellulitis; This is a spontaneous report received from an Other HCP from medical information team.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Localized cellulitis".  Additional information: Localized cellulitis as an adverse effect of the PCV20 vaccine. There was one confirmed patient who has had that in the last week. They have been doing some research, and it looked like it was a rare occurrence in PCV23, but did not see anything related to PCV20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122230 same reporter/product/AE, different patient;
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: Suspected of having localized cellulitis; This is a spontaneous report received from an Other HCP from medical information team.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Suspected of having localized cellulitis".  Additional information: It was noted that another patient who was suspected of having localized cellulitis.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500121558 same reporter/product/AE, different patient;
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Spinal pain, Vomiting
Clinical narrative: she is having terrible pain in her back, the lower spine and it is excruciating/can't roll out of her bed or roll over; she is having terrible pain in her back, the lower spine and it is excruciating/can't roll out of her bed or roll over; vomiting; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Jun2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for immunization; Covid-19 vaccine (dose 3, manufacturer unknown), for immunization; Comirnaty (dose number unknown (booster), single), for immunization, reaction(s): "no adverse effect". The following information was reported: BACK PAIN (medically significant); SPINAL PAIN (medically significant), outcome "unknown", both described as "she is having terrible pain in her back, the lower spine and it is excruciating/can't roll out of her bed or roll over"; VOMITING (non-serious), outcome "unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Neurodermatitis
Clinical narrative: after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted; after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted; This is a spontaneous report received from a Consumer or other non HCP from License Party.  A 74-year-old male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 26Mar2021 (Lot number: 3F306A, Expiration Date: 30Sep2025) at 300 mg (300 mg, qow (every other week), single dose prefilled pen, strength: 300 mg/2 ml) and second regimen since 06Jan2023) at 300 mg (300 mg, qow (every other week), single dose prefilled pen), all subcutaneous for neurodermatitis. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE HYCLATE; AQUAPHOR [XIPAMIDE]; SAW PALMETTO [SERENOA REPENS]; VITAMIN D3; VITAMIN E [VITAMIN E NOS]; MUPIROCIN; CLOBETASOL; CETAPHIL [ALOE VERA;PANTHENOL]; CETAPHIL [CETYL ALCOHOL;SODIUM LAURYL SULFATE;STEARYL ALCOHOL]; ROBITUSSIN COLD & COUGH; AQUAPHOR [MINERAL OIL LIGHT;PARAFFIN;PETROLATUM;WOOL ALCOHOLS]. The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (DOSE 1, unknown manufacturer), for COVID-19 immunization. The following information was reported: NEURODERMATITIS (non-serious), DISEASE RECURRENCE (non-serious), outcome "recovering" and all described as "after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted". Therapeutic measures were taken as a result of neurodermatitis, disease recurrence. Additional information: Concomitant medications also included vitamins NOS and Cerave daily moisturizing lolion. Patient stated he started Dupixent about 3 years before an unknown date. He was symptoms free after about 1 year and stopped Dupixent, but after receiving his 2 Covid-19 vaccines his symptoms came back so he restarted. His symptoms were again well controlled and doctor agreed to have patient try to stop Dupixent to see if he could go without it. The event was reported as non-serious by Sanofi.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  BNT162b2 is under agreement with BIONTECH SE.
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block left, Electrocardiogram
Clinical narrative: new diagnosis of left bundle branch block; This is a spontaneous report received from a Nurse, Program ID.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 infections" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Pfizer covid vaccine (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: BUNDLE BRANCH BLOCK LEFT (non-serious), outcome "unknown", described as "new diagnosis of left bundle branch block". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller is an RN and calling one behalf of herself asking medical question regarding a new diagnosis of left bundle branch block (LBBB). She expresses concern about the possible causes, particularly in relation to her history of COVID-19 infections (four lab-confirmed cases since 2019) and having received three doses of the Pfizer COVID vaccine. She clarifies that she is not blaming the vaccine but is trying to understand if there is any known link between LBBB and either getting COVID-19 or Pfizer Covid vaccine. She notes that she is otherwise cardiovascularly healthy, with no plaque buildup or evidence of infarct in short Asymptomatic, and this is the first time LBBB has appeared on her EKG.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered with DAPTACEL instead of Tdap (ADACEL) with no reported AE; Initial information received on 13-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient who had administered Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of tdap (adacel) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Jun-2025, the patient received 0.5 ml  dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot 3CA20C, Frequency:once, strength: standard, via intramuscular route in the left arm for immunisation instead of tdap (adacel) with no reported adverse event (wrong product administered) (latency: same day).  Reportedly, patient was administered with DAPTACEL instead of Tdap (ADACEL). Caller wanted to know if the dose should be repeated.  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.
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered a YF-Vax reconstituted using sterile water with no reported adverse event; Initial information received on 13-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who was administered a yellow fever vaccine -[YF-VAX] reconstituted using sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect yellow fever vaccine - reconstituted using sterile water (formulation: Solution for injection) (lot UK137AA and expiry date 31-Jan-2026) (strength not reported) via unknown route in unknown administration site for immunization with no reported adverse event (product preparation error) (Latency: same day).  Reportedly, she was administered yellow fever vaccine and noticed there was two vials of the sodium chloride left which should have been used with the vaccine.  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: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: None stated.