chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt received Hep B component of the vaccine 1 month before the recommended schedule.  Pt had no reaction, symptoms or complaints.
Age: 1.33
Sex: F
Vaccine: TDAP
Symptoms: Fall, Wrong patient
Clinical narrative: Patient was being seen in emergency department due to a fall. Patient was accidentally given vaccine that was intended for a different patient.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: om called us on 7/15 to notify us that over the weekend patient developed what she believed to be a vaccine reaction. reported he had a low grade fever of 99.9 friday 7/12 evening and that over the weekend his L thigh down to his knee had become red and swollen and warm to the touch. reported at time of phone call that site is improving and is not wanting to be seen by pcp. dr. was notified of this reaction and it was noted in patients chart by nurse manager.
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Flushing, Loss of consciousness
Clinical narrative: Patient got flushed and light headed and ended up passing out. husband and I both supported patient in chair till she came to. after i got her some water and layed her down on a bench. after 10 minutes or so I assisted patient to their car and husband drove her home.
Age: 0.17
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HPV vaccine inadvertently given to a 2mth old instead of PCV vaccine.No symptoms or signs seen during period of post vaccine observation while in clinic
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough infection
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal distension, Blepharospasm, Drug hypersensitivity, Flatulence, Joint swelling
Clinical narrative: The day after the vaccine I had a spasm consistently in my left eye for two days. The following two days I had a painful leg spasm in my upper left thigh for two days. On the 5th the top  of my right foot started to hurt and by the end of that week it was incredibly painful and my whole foot and ankle had swollen. The pain and the swelling have still not gone away. The doctors don't know what is going on. Just my right foot. Pain and swelling has not improved. There is no blood clot. It has been 6 weeks at this point and zero improvement. I had severe nausea through week 5. Very aggressive bloating and gas, which has finally started to subside. Though the nausea is still present, it has decreased a good amount.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test normal, Muscle spasms, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: The day after the vaccine I had a spasm consistently in my left eye for two days. The following two days I had a painful leg spasm in my upper left thigh for two days. On the 5th the top  of my right foot started to hurt and by the end of that week it was incredibly painful and my whole foot and ankle had swollen. The pain and the swelling have still not gone away. The doctors don't know what is going on. Just my right foot. Pain and swelling has not improved. There is no blood clot. It has been 6 weeks at this point and zero improvement. I had severe nausea through week 5. Very aggressive bloating and gas, which has finally started to subside. Though the nausea is still present, it has decreased a good amount.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Bone pain, Myalgia
Clinical narrative: Patient came in today and said he suffered from severe bone aches and muscle aches with and his feet and arms being most impacted. He states that he finally is almost back to normal now but wanted us to know about this.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Frequent daily heart palpitations never experienced before
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: unknown
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 5 y/o pt received expired vaccine. Physician and parent made aware. No adverse side effects.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Hypopnoea, Nausea, Pallor, Tachycardia
Clinical narrative: Approx 2.5 hrs after vaccine and after a work out with trainer  developed nausea, pallor, clamminess, shaking, tachycardia 120 and shallow respirations, vomited twice. No fever.  After 15-20 minutes symptoms slowly improved and pt stablilized.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Tremor, Vomiting
Clinical narrative: Approx 2.5 hrs after vaccine and after a work out with trainer  developed nausea, pallor, clamminess, shaking, tachycardia 120 and shallow respirations, vomited twice. No fever.  After 15-20 minutes symptoms slowly improved and pt stablilized.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vaccine error. Patient given adult dose of recombivax at 17 years of age. Patient father and Merck notified, patients father reports no adverse side effects of symptoms.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Cholecystectomy, Colectomy, Colostomy, Detoxification
Clinical narrative: PFIZER #1 5/7/2021 PFIZER #2 8/6/2021, BY JAN, 2022 DEVELOP LOWER EXTREMITY EDEMA AND WAS DIAGNOSED WITH A VACCINE INDUCED STEROID AUTO-IMMUNE SYNDROME WITH MIGRATORY THROMBOPHLEBITIS.  JAN 2024 HAS ACUTE CHOLESTETECTOMY FOLLOWED BY RUPTURED DIVERTICULUM REQUIRING COLONIC RESECTION AND COLOSTOMY.   JUL 2024 DIAGNOSED WITH VACCINE INDUCED SUBCLINICAL MYOPERICARDITIS.  TREATED WITH PREDNISONE, ELIQUIS, COLCHICINE,  TORSEMIDE, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Immunisation reaction, Laboratory test, Laparoscopic surgery
Clinical narrative: PFIZER #1 5/7/2021 PFIZER #2 8/6/2021, BY JAN, 2022 DEVELOP LOWER EXTREMITY EDEMA AND WAS DIAGNOSED WITH A VACCINE INDUCED STEROID AUTO-IMMUNE SYNDROME WITH MIGRATORY THROMBOPHLEBITIS.  JAN 2024 HAS ACUTE CHOLESTETECTOMY FOLLOWED BY RUPTURED DIVERTICULUM REQUIRING COLONIC RESECTION AND COLOSTOMY.   JUL 2024 DIAGNOSED WITH VACCINE INDUCED SUBCLINICAL MYOPERICARDITIS.  TREATED WITH PREDNISONE, ELIQUIS, COLCHICINE,  TORSEMIDE, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laparotomy, Large intestine perforation, Myopericarditis, Oedema peripheral, Thrombophlebitis
Clinical narrative: PFIZER #1 5/7/2021 PFIZER #2 8/6/2021, BY JAN, 2022 DEVELOP LOWER EXTREMITY EDEMA AND WAS DIAGNOSED WITH A VACCINE INDUCED STEROID AUTO-IMMUNE SYNDROME WITH MIGRATORY THROMBOPHLEBITIS.  JAN 2024 HAS ACUTE CHOLESTETECTOMY FOLLOWED BY RUPTURED DIVERTICULUM REQUIRING COLONIC RESECTION AND COLOSTOMY.   JUL 2024 DIAGNOSED WITH VACCINE INDUCED SUBCLINICAL MYOPERICARDITIS.  TREATED WITH PREDNISONE, ELIQUIS, COLCHICINE,  TORSEMIDE, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Myalgia
Clinical narrative: REDNESS AND SORE MUSCLE
Age: 38.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Patient stated she developed a rash the evening following her vaccines. The rash worsened by the next day, covering her trunk and extemeties. She called our office to report the rash. She denied any SOB, swelling or other changes in breathing. She denied  previous problems with MMR or Tdap however Heplisav was new to her. She was instructed to take Benedryl and if her symptoms worsened to go to an urgent care or the ER if she experienced breathing problems or swelling in her tounge. She called 2 days later to report she went to an urgent care over the weekend due to worsening of her rash and itching. She denied any contact with new lotions, medicine or food. She reported the urgent care gave her a a steroid injection, a prednisone dose pack and something for itching.  Her symptoms improved over the next few days and symptom free by 7/8/2024.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT WAS GIVEN VACCINE THAT EXPIRED 06/30/2024. PATIENT WAS ADVISED TO COME AND GET ANOTHER DOSE THAT IS NOT EXPIRED. NO ADVERSE REACTIONS REPORTED.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Injection site rash, Rash, Rash pruritic
Clinical narrative: very bright purple bruise 3 days later and itchy bumps all over body from neck down, bumps are worse right under the injection site; bumps are rather large, not small like typical hives
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Decreased appetite, Irritability, Lethargy, Pallor, Pyrexia
Clinical narrative: After the pt was immunized the mom and nursing staff noticed that he was pale.  The physician came in to evaluate him and said that he did appear pale and lethargic.  We checked his vital signs. At first his heart rate was in the 120's but came up to the 150's.  There was no sign of respiratory distress.  Oxygen saturation was good.  The physician thought me might have had a vasovagal episode.  We monitored him for about a half hour.  His color came back and he seemed to be doing better.  I spoke to mom the next day and she said that he was more fussy and had a fever up to about 101.  The next day she said he did not want to eat as good. I talked to her today which is 3 days after and she says that he is seeming back to normal.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Administered incorrect vaccine, Pediarix. Pt should have received Pedvac. No harm, counted as an extra invalid dose. Informed pt's mother ,ad PCP. Pt will return to office to receive correct immunization.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient states that he had a sore arm from shoulder down to wrist 6 days after the injection. He reported to the urgent care 7/14/24 and was advised to see an orthopedic.
Age: 64.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Allergy to synthetic fabric, Dermatitis contact, Feeling abnormal, Paraesthesia, Skin test
Clinical narrative: Since the vaccine shot, I have been allergic to polyester in clothes, material, and furniture. I had the same chair for years; now my skin starts tingling when I set on it. I also bought new cloth couches and the same thing happens. It only stops when I take a shower. I had to give my couches away. This was all before I took a patch test from clinic.I bought leather couches only  to find out they have polyester batting. Can't sit on it. As of today, I am giving that furniture away. I also had to give away all my clothes made of polyester. I have lost a lot of money because of this vaccine. I still don't know what kind of furniture I can buy. When we wash clothes the fumes irritates me. I've been miserable for years.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cognitive disorder, Dizziness, Fatigue, Hypertension
Clinical narrative: diiness, tingling starting in feet, spines, high blood pressure, swelling of face, night sweats, fitigue, insominia
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Night sweats, Paraesthesia, Red blood cell sedimentation rate increased, Spinal disorder
Clinical narrative: diiness, tingling starting in feet, spines, high blood pressure, swelling of face, night sweats, fitigue, insominia
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: diiness, tingling starting in feet, spines, high blood pressure, swelling of face, night sweats, fitigue, insominia
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: used MMRV instead of MMR; indicate at which point in the process the medication error ocurred: preparation for administration; used MMRV instead of MMR and used separate vaccine for Varicella; no adverse reaction occured; This spontaneous report was received from a Medical Assistant and refers to a 15-month-old female. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 13-MAY-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (recombinant Human albumin), lot #X024913, expiration date: 14-APR-2025, administered for prophylaxis at right thigh (strength, and route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X026320, expiration date: 07-NOV-2025, administered for prophylaxis at left thigh (strength, and route of administration were not provided); hib vaccine conj (tet tox) (ACT HIB), lot# UJ778AA, expiration date: 08-NOV-2024, administered at right thigh (strength, formulation, route of administration, and indication were not provided); hepatitis a vaccine inact (HAVRIX), lot# 423NL, expiration date: 16-NOV-2025, administered at right thigh (strength, formulation, route of administration, and indication were not provided); and pneumococcal vaccine conj 7v (crm197) (PREVNAR), lot# HH4722, expiration date: 01-AUG-2025, administered at left thigh (strength, formulation, route of administration, and indication were not provided). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was used instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (manufacturer unknown) and they used separate vaccine for varicella (wrong product administered, product preparation error, accidental overdose). At visit provider and parents were notified. No adverse reaction occurred.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions occured; accidental overdose; inappropriate age at vaccine administration; product preparation error; wrong vaccine administered; This spontaneous report was received from a medical assistant and refers to a 6-day-old female patient. No information on patient's medical history and current conditions. Concomitant therapies included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), hepatitis a vaccine inact(HAVRIX) and hib vaccine conj (tet tox) (ACT HIB).  On 20-MAY-2024 the patient (6-day-old) was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X026320 and expiration date 07-NOV-2025 in the right thigh (exact dose and route of administration were not provided) for prophylaxis and with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X024913 and expiration date 14-APR-2025 in the left thigh (exact dose and route of administration were not provided) for prophylaxis at the same day, instead of  being vaccinated with and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No adverse reaction occurred (accidental overdose, wrong product administered, product preparation error and product administered to patient of inappropriate age).
Age: 0.58
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Varivax and Proquad on the same day; indicate at which point in the process the medication error occurred: preparation; used MMRV instead of MMR; This spontaneous report was received from a medical assistant and refers to a 13-month-old male patient. No information on patient's medical history and current conditions. Concomitant therapies included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), hepatitis a vaccine inact(HAVRIX) and hib vaccine conj (tet tox) (ACT HIB).  On 13-MAY-2024 the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X026320 and expiration date 07-NOV-2025 in the right thigh (exact dose and route of administration were not provided) for prophylaxis and with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X024913 and expiration date 14-APR-2025 in the left thigh (exact dose and route of administration were not provided) for prophylaxis at the same day, instead of  being vaccinated with and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No adverse reaction occurred (accidental overdose, wrong product administered, product preparation error and no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The caller said a 27 year old patient received one dose of GARDASIL 9 on 9/1/2023. The caller said the patient did not receive any additional doses. Confirmed no other AE occurred. No further information provided; No other AE.ocurred; This spontaneous report was received from a pharmacist and refers to a current 27-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-SEP-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W028355, which had been verified to be a valid lot number, expiration date reported and confirmed as 07-JUN-2025, administered for prophylaxis (strength, dose, and route of administration were not provided). The reporter informed the patient did not receive any additional doses (inappropriate schedule of product administration). It was also confirmed that no other adverse event (AE) occurred (no adverse event). No further information provided.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no adverse event; accidental overdose; Product preparation error; wrong product administered; This spontaneous report was received from a medical assistant and refers to a 13-month-old male patient. No information on patient's medical history and current conditions. Concomitant therapies included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), hepatitis a vaccine inact(HAVRIX) and hib vaccine conj (tet tox) (ACT HIB).  On 13-MAY-2024 the patient was vaccinated with first dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X026320 and expiration date 07-NOV-2025 in the right thigh (exact dose and route of administration were not provided) for prophylaxis and with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # X024913 and expiration date 14-APR-2025 in the left thigh (exact dose and route of administration were not provided) for prophylaxis at the same day, instead of  being vaccinated with and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No adverse reaction occurred (accidental overdose, wrong product administered, product preparation error and no adverse event).
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose of Heplisav-B, and Received Second Dose of Glaxo Smith Kline; Initial report received on received on 25-Jun-2024.  A consumer in the reported that her daughter, a 22-year-old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received the second dose with ENGERIX-B.   No relevant medical history was reported.  The patient had no known drug allergies.  No relevant concomitant medications were reported.  On 19-May-2024, the patient received the first dose of HEPLISAV-B (lot number 943006, expiration date unknown, and NDC 43528-002-01) intramuscularly in the left arm.   On 24-Jun-2024, 1 month and 6 days after being vaccinated with HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine, ENGERIX-B (no details provided). The patient had no other side effects reported.  No further information was available.    Company Comment:      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First and Second Dose Four Years Apart; Initial report received on 27-Jun-2024.  A nurse in the reported that a 54-year-old male (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received the second dose four years later.  Medical history and concomitant medications were not reported.   On 06-Mar-2020, the patient received the first dose of HEPLISAV-B (lot number 933839, expiration date 25-Feb-2021, NDC #, route, and site administered not reported).   On 27-Jun-2024, four years 3 months and 22 days after being vaccinated with HEPLISAV-B, the patient received the second dose of HEPLISAV-B (lot number 944914, expiration date 05-Sep-2026, and NDC # 43528-003-05, route and site administered not reported). No adverse reactions were reported.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received first dose, has not received the second; Initial report received on 08-Jul-2024.  A reporter reported that a patient (age, gender, race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and has not received the second scheduled dose after six months.  No relevant medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On an unknown date, the patient received the first dose of HEPLISAV-B (lot #, expiration date, and NDC # not reported, injection site and route unknown).  No further information is available.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HIBV
Symptoms: Single component of a two-component product administered
Clinical narrative: patient given diluent only without first reconstituting; patient given diluent only without first reconstituting; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: patient given diluent only without first reconstituting) and inappropriate dose of vaccine administered (Verbatim: patient given diluent only without first reconstituting). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 02 Jul 2024 A reporter reported that a patient given diluent only without first reconstituting which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received late; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th June 2018).   On 20-JUL-2020, the patient received the 2nd dose of Shingrix. On 20-JUL-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose received late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-JUL-2024 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. This case is linked with US2022AMR099782, same reporter, different patient.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Underdose
Clinical narrative: patient did not receive a full dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On an unknown date, the patient received Kinrix (left deltoid). On an unknown date, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: patient did not receive a full dose). The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 05 Jul 2024 A nurse reported that he/she was administering Kinrix to a patient, when the patient's mother let go of the patient's arm because of this, the needle come out of the patient's arm and patient did not receive a full dose which led to incomplete dose administered.
Age: 50.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arexvy was given by accident to a 50 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 50-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 42852, expiry date 06-JUL-2025) for prophylaxis.   On 05-JUL-2024, the patient received Arexvy. On 05-JUL-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy was given by accident to a 50 year old patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2024 The pharmacist called to inform that a dose of Arexvy was accidently given to a 50 year old patient.  Reporter confirmed that such dose had been given on 05 July 2024.  The reporter agreed to follow up by pharmacovigilance team and gave the following phone number for such purpose. The patient received a dose of Arexvy at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: warmth at the injection site; redness at the injection site; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site warmth in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site warmth (Verbatim: warmth at the injection site) and injection site erythema (Verbatim: redness at the injection site). The outcome of the injection site warmth and injection site erythema were unknown.   It was unknown if the reporter considered the injection site warmth and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site warmth and injection site erythema to be related to Bexsero and Bexsero 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: 05-JUL-2024 Health Professional reported a patient developed redness and warmth at the injection site after receiving Bexsero.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st April 2023).   On 04-MAY-2024, the patient received the 2nd dose of Shingrix. On 04-MAY-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2024 The reporter was the patient.  The patient received the first dose of Shingrix on April 1, 2023, and the second dose on May 4, 2024. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. The case is linked with US2024084043, same reporter.; Sender's Comments:  US-GSK-US2024084043:same reporter, different patient
Sex: U
Vaccine: RSV
Symptoms: Intercepted product storage error
Clinical narrative: product storage error/removed the caps but didn't puncture the vials/have been in the refrigerator for 30 mins; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9R25L, expiry date 21-MAR-2025) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product storage error (Verbatim: product storage error/removed the caps but didn't puncture the vials/have been in the refrigerator for 30 mins). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2024 The pharmacy tech request data on stability of Arexvy following cap removal. The patient come in to receive an Arexvy vaccine and decided against it, they removed the caps but did not puncture the vials and had been in the refrigerator for 30 minutes, which led to intercepted product storage error. The reporter asked that how long that they were stable to use.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 2 patients received an extra dose of SHINGRIX today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number 4723f, expiry date 14-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of Shingrix in 2020) and Shingrix (Received 2nd dose of Shingrix in 2020).   On 05-JUL-2024, the patient received the 3rd dose of Shingrix. On 05-JUL-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 2 patients received an extra dose of SHINGRIX today). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2024 The pharmacist reported that, 2 patients received an extra dose of Shingrix on the day of reporting.  The pharmacist reported both patient got 2 doses in 2020 but the system did not display that information.  The pharmacist realized they both received an extra dose on the day of reporting after the system fixed itself which led to extra dose administered.  The patients did not want to share demographic information.  The reporter consented to follow up.
Age: 32.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Bexsero on Friday, 5-JUL-2024; 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 32-year-old male patient who received Men B NVS (Bexsero) (batch number 9R42C, expiry date 30-JUN-2024) for prophylaxis.   On 05-JUL-2024, the patient received Bexsero. On 05-JUL-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Bexsero on Friday, 5-JUL-2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUL-2024 The medical assistant reported that the patient received an expired dose of Bexsero on Friday, which led to expired vaccine used. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash macular, Vaccination failure
Clinical narrative: Suspected vaccination Failure; Shingles on left torso, but also spots on various parts of my body; spots on various parts of my body; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 77-year-old male 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. In JUN-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on left torso, but also spots on various parts of my body) and spot-like rash (Verbatim: spots on various parts of my body). The outcome of the vaccination failure was unknown and the outcome of the shingles and spot-like rash were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and spot-like rash to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles and spot-like rash to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 08-JUL-2024 The patient live a very active life, especially bicycling and eat a whole food vegetarian diet.  The patient had the two-dose Shingrix vaccine a couple of years ago and two weeks ago the patient developed shingles particularly on the left torso, but also spots on various parts of the body.  The patient was curious to knew about why the vaccine was not totally effective for some people and also about next steps once the condition clears up.  The reporter asked if could, get a second round of the vaccine. The patient said that he had not recovered from the shingles outbreak and said that he still had places popping up. Consented to follow up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix dose 1 and Shingrix dose 2.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Meningitis viral
Clinical narrative: patient (HCP) developed Ramsey Hunt Disease and Viral meningitis after receiving her first initial SHINGRIX vaccine; patient (HCP) developed Ramsey Hunt Disease and Viral meningitis after receiving her first initial SHINGRIX vaccine.; This serious case was reported by a physician via sales rep and described the occurrence of ramsay-hunt syndrome in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced ramsay-hunt syndrome (Verbatim: patient (HCP) developed Ramsey Hunt Disease and Viral meningitis after receiving her first initial SHINGRIX vaccine) (serious criteria hospitalization and GSK medically significant) and viral meningitis (Verbatim: patient (HCP) developed Ramsey Hunt Disease and Viral meningitis after receiving her first initial SHINGRIX vaccine.) (serious criteria hospitalization and GSK medically significant). The outcome of the ramsay-hunt syndrome and viral meningitis were unknown.   It was unknown if the reporter considered the ramsay-hunt syndrome and viral meningitis to be related to Shingrix.     The company considered the ramsay-hunt syndrome and viral meningitis to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 08-JUL-2024 This case was reported by patient herself. The patient (health care professional) developed ramsey hunt disease and viral meningitis after receiving her first initial Shingrix vaccine. The patient had a hospital stay of 3 weeks. The reporter consented to follow up.; Sender's Comments: Herpes zoster oticus and Meningitis viral are unlisted event which are considered unrelated to GSK vaccine Shingrix.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: had already completed the series, so dose administered was patient's third dose; patient had prior doses, 1st dose on 02-Nov-2021 and 2nd dose on 23-Mar-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number XZ7CB, expiry date 21-APR-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 02-NOV-2021). Concurrent medical conditions included type ii diabetes mellitus (has Type 2 diabetes).   On 09-JUL-2024, the patient received the 3rd dose of Shingrix. On 23-MAR-2023, the patient received the 2nd dose of Shingrix. On 23-MAR-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient had prior doses, 1st dose on 02-Nov-2021 and 2nd dose on 23-Mar-2023). On 09-JUL-2024, the patient experienced extra dose administered (Verbatim: had already completed the series, so dose administered was patient's third dose). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 09-JUL-2024 The pharmacist reported that the patient came in to pharmacy requesting Shingrix series and stated that would be her first dose of Shingrix vaccine.   After the dose was administered, it was realized that the patient had already completed the series, so the dose administered on the reporting day was the patient's third dose, which led to extra dose administered. The patient had prior 2 doses and however the pharmacist did not had this lot number or expiration date information. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: MNP
Symptoms: Syncope
Clinical narrative: Syncope; Collapse; This is a spontaneous report received from a Physician from a sales representative.  A male patient received meningococcal group abcwy vaccine (PENBRAYA), on 10Jul2024 at 16:00 as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CIRCULATORY COLLAPSE (medically significant) with onset 10Jul2024 at 16:00, outcome "recovered" (10Jul2024), described as "Collapse"; SYNCOPE (medically significant) with onset 10Jul2024 at 16:00, outcome "recovered" (10Jul2024). It was unknown if therapeutic measures were taken as a result of syncope, circulatory collapse. Clinical course: No other vaccines on same date. No other vaccines in four weeks. The patient had no known allergies.  The information on the batch/lot number for meningococcal group abcwy vaccine will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, and close temporal association the event syncope is assessed as related to the suspect drug MENINGOCOCCAL GROUP ABCWY VACCINE. The event circulatory collapse is conservatively assessed as related to the suspect drug based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Single component of a two-component product administered
Clinical narrative: administered PENTACEL to a patient, but the liquid DTaP-IPV solution was not mixed with the HIB powder (with no reported adverse event); Initial information received on 08-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 months old male patient who got administered diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] to a patient, but the liquid dtap-ipv solution was not mixed with the hib powder (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (hepatitis b [hepatitis b vaccine]); pneumococcal vaccine conj 20v (crm197) (prevnar 20) and rotavirus vaccine for Prophylactic vaccination.  On 08-Jul-2024, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Powder and suspension for suspension for injection (lot- UK036AB and expiration date- 30-JUN-2025) via intramuscular route in the right thigh (strength: not provided) for Immunisation (single component of a two-component product administered) (latency- same day).  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: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administered adacel to a patient today but eventually noted that the patient had her adacel vaccine 07sep2021 with no reported adverse event; Initial information received on 08-Jul-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 65 years old female patient to whom administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 08-Jul-2024  but eventually the patient had her adacel vaccine 07sep2021 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2021, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection via unknown route in unknown administration site and on 08-Jul-2024 she received same vaccine with batch U8122AA and expiry-30-Apr-2026 via unknown route in unknown administration site for immunization (strength, dose unknown).  On 08-JUL-2024 administered adacel to a patient today but eventually noted that the patient had her adacel vaccine 07sep2021 with no reported adverse event (inappropriate schedule of product administration) (latency same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: Act HIB component of the PENTACEL vaccine was given with a different diluent with no reported adverse event; Initial information received on 08-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient to whom Act HIB component of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] vaccine was given with a different diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine and rotavirus vaccine live reassort oral 5V (Rotateq) for Prophylactic vaccination.   On 02-Jul-2024, the patient received a 0.5 ml dose (total, once) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ983AA, expiry date: 12-Feb-2025, strength: unknown) via unknown route in unknown administration site for Immunization and Act HIB component of the Pentacel was given with a different diluent (product preparation error) (Latency: same day).  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.