chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Culture negative, Cyst, Incisional drainage, Injection site discolouration
Clinical narrative: 05/01/25 Patient received Vaccination in the left arm, witness to the vaccine and patient stated it was administered about 1 finger width(approximately 5/8) below the shoulder bone into the left deltoid. Symptoms started 3 hours post administration. Pt experienced severe pain in the left shoulder. Symptoms progressed to pain in the left arm from the shoulder down to the elbow and arm turned blue. 05/01/25 3 hours 45 minutes post vaccine administration pt calls 911 and is transported by ambulance to the emergency room  -
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site, Suture insertion
Clinical narrative: 05/01/25 Patient received Vaccination in the left arm, witness to the vaccine and patient stated it was administered about 1 finger width(approximately 5/8) below the shoulder bone into the left deltoid. Symptoms started 3 hours post administration. Pt experienced severe pain in the left shoulder. Symptoms progressed to pain in the left arm from the shoulder down to the elbow and arm turned blue. 05/01/25 3 hours 45 minutes post vaccine administration pt calls 911 and is transported by ambulance to the emergency room  -
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea and vomiting. Hydration and rest.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Disorientation, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: At 10:45am, RN heard thud against documentation desk and mother shout for help from clinic room 3. RN entered to see client unresponsive and breathing on clinic floor. Ten seconds after RN entered room as RN assessing client, client roused spontaneously. Client disoriented to syncopal event, though alert and oriented. Client recognized mother immediately and responded appropriately to her. Client supported by RN while sitting on clinic floor. Client's skin pale, lips pink, and mucous membranes moist. Client stated being thirsty; water and teddy grahams provided. RN asked client if felt lightheaded or dizzy before event; client denied feeling lightheadedness/dizziness before syncopal episode. Client stated everything "suddenly went black." Asked if client ate breakfast before coming to visit; client denied eating breakfast this morning, which mother was unaware of because mother stated is atypical that client doesn't eat breakfast. Client able to tolerate water and grahams. After sitting on floor for 15 minutes, client stated feeling better; denied lightheadedness/dizziness. However, no change to skin condition. Mother assisted client slowly to standing. Had client stand for two minutes; client denied lightheadedness/dizziness. Client proceeded to slowly ambulate from clinic room 3 with assistance of mother and RN. Client ambulated to outside DON office before RN noticed signs client becoming lightheaded (client looking down at ground and balance wavering). RN had client stop ambulating, asked client if needed to sit down. Client at first denied needing to sit and denied lightheadedness, but then after 30 seconds asked to sit down against the hall wall. After client sitting, client asked for more water; water provided. Mother made arrangements for another adult to meet her at home to assist with watching client. After 15 minutes, no change to skin condition. RN asked client if feeling better. Client stated feeling marginally better and denied lightheadedness, but client does not feel able to ambulate from clinic to private vehicle. RN offered to escort client from clinic to private vehicle via wheelchair. Client and mother agreeable. Client able to stand to sit in wheelchair with minimal assistance and able to get out of wheelchair to private vehicle with minimal assistance. Gave final instructions to mother. Client left premises with mother via private vehicle at 11:23am.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Laboratory test, Positive airway pressure therapy, Pulmonary oedema, Respiratory disorder
Clinical narrative: pt states she started having water retention. She was gaining 10 pounds of water weight every month after getting the second vaccine for nine months straight. She gained a total of 95 pounds. She started seeing an internal med specialist and she was told it was from the vaccine. He is treating her with diuretics and potassium. She only looses a few pounds and it comes right back. She now has respiratory fluid that she is dealing with. She spent a couple of days at hospital for respiratory problems. She is on a C-Pap machine at night and a portable O2 machine. She needed the C-Pap machine prior to the vaccine but not the O2. She was seen by a cardiologist and pulmonologist for her heart and lungs all test were good. These test were performed at Tacoma Kaiser location. She continues treatment with her internal med Dr.  She says it has ruined her life.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: pt states she started having water retention. She was gaining 10 pounds of water weight every month after getting the second vaccine for nine months straight. She gained a total of 95 pounds. She started seeing an internal med specialist and she was told it was from the vaccine. He is treating her with diuretics and potassium. She only looses a few pounds and it comes right back. She now has respiratory fluid that she is dealing with. She spent a couple of days at hospital for respiratory problems. She is on a C-Pap machine at night and a portable O2 machine. She needed the C-Pap machine prior to the vaccine but not the O2. She was seen by a cardiologist and pulmonologist for her heart and lungs all test were good. These test were performed at Tacoma Kaiser location. She continues treatment with her internal med Dr.  She says it has ruined her life.
Age: 84.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient indicated she had extreme swelling, redness and pain at the injection site.  She does not remember that ever happening with an other vaccine in the past.  It began fairly quickly and lasted several days, but has gotten better recently (about 7 days later).
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Unable to note any adverse events as the error was discovered after client left office.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: given vaccine with expiration date 5/19/2025
Age: 4.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Product administered to patient of inappropriate age
Clinical narrative: A 4-year-old female was inadvertently administered the first dose of the HPV vaccine (Gardasil 9) during a routine well-child visit. The error was identified immediately after administration when staff noticed the vaccine was not indicated for the patient age group (approved for ages 9 and older). The patient experienced no adverse effects. She remained alert and active during the post-vaccination observation period, No fever, rash, or behavioral changes were reported by parent. Pt did have arm pain at the injection site which resolved the same day. Dr. called mom on  5/26/26 to check on patient. mom stated patient was doing well with no adverse reaction.
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Productive cough
Clinical narrative: Severe coughing with foamy phlegm
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen injection site, itchy, warm and hard to touch for 3 days after injection
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram heart, Diarrhoea, Echocardiogram, Laboratory test, Myocarditis
Clinical narrative: Myopericarditis. hospitalization and ambulance transportation to hospital. nausea and vomiting, diarrhea, and pleuritic chest pain. admited for likely pericarditis with mild myocarditis.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Myopericarditis, Nausea, Pericarditis, Pleuritic pain, Ultrasound Doppler abnormal
Clinical narrative: Myopericarditis. hospitalization and ambulance transportation to hospital. nausea and vomiting, diarrhea, and pleuritic chest pain. admited for likely pericarditis with mild myocarditis.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Myopericarditis. hospitalization and ambulance transportation to hospital. nausea and vomiting, diarrhea, and pleuritic chest pain. admited for likely pericarditis with mild myocarditis.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Parent brought child in 2 days after the immunization.  Her left leg was red, Swollen and painful with no tenderness.   Patient with Benedry, Claritin and Clindamycin.   Also, she was advised to apply a cool compress to site.   On 5/27/25 spoke with mom and she stated that patient is doing well,  No longer has swelling, or redness.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Pt took HPV #1 on 5/19. On 5/21 she developed hives to neck and back. Unclear if related to vaccine or not. No other new exposures
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying, Injection site pain, Rash, Screaming, Seizure
Clinical narrative: Crying/screaming for hours at a time for multiple days, generally irritated - didn't want to be held and would cry out if held, leg hurt where injected, skin rashes all over, and had a seizure about a month after the injection.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin normal, Dermatitis contact, Dry skin, Haemorrhage, Skin exfoliation
Clinical narrative: 2 months post vaccine I began to develop a small patch on my left palm of what I thought was dryness from washing hands with alcohol gel.  This continued and red patch developed into dry flaky, cracking and bleeding.  This spread to the right palm and exhibited same contact dermatitis as the left.  Dr. could not determine what this was so she did a biopsy and it did not come back as virus.  Treatment of a steroid was prescribed and had zero affect after 6 months.  Next treatment was .1% Tacrolimus Ointment, and have been on this for >6 months. Had little or no affect, so stopped using and now just apply Eucerin to keep the palms from drying out.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin fissures
Clinical narrative: 2 months post vaccine I began to develop a small patch on my left palm of what I thought was dryness from washing hands with alcohol gel.  This continued and red patch developed into dry flaky, cracking and bleeding.  This spread to the right palm and exhibited same contact dermatitis as the left.  Dr. could not determine what this was so she did a biopsy and it did not come back as virus.  Treatment of a steroid was prescribed and had zero affect after 6 months.  Next treatment was .1% Tacrolimus Ointment, and have been on this for >6 months. Had little or no affect, so stopped using and now just apply Eucerin to keep the palms from drying out.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: No symptoms or signs at the time of visit. Patient was given an expired covid 19 vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hemiparesis, Inflammation, Injection site pain, Injection site paraesthesia
Clinical narrative: First injection: 04/03/2021 led to pain and soreness in upper left arm.  Two days later, swelling and tingling in the area.  Second injection: 04/25/2025 led to pain in my left hip three weeks later, in May 2025.  In June and July 2025, I developed pain and weakness down the left side of my body.  In August 2025, I developed pain and tingling in my left foot.  By mid-September 2025, I developed heavy swelling and pain in my left knee, all the way down to my heavily swollen left foot.  I finally went to the doctor on 10/07/2025.  Bloodwork showed I had become serum positive for RA.  I then developed swelling and pain in my right knee as well.  My body has been messed up ever since I elected to get the covid vaccinations.  I wish I had never done so. I also developed osteoarthritis as well.  I was in robust health and very active before the injections
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Joint swelling, Magnetic resonance imaging abnormal, Osteoarthritis, Pain
Clinical narrative: First injection: 04/03/2021 led to pain and soreness in upper left arm.  Two days later, swelling and tingling in the area.  Second injection: 04/25/2025 led to pain in my left hip three weeks later, in May 2025.  In June and July 2025, I developed pain and weakness down the left side of my body.  In August 2025, I developed pain and tingling in my left foot.  By mid-September 2025, I developed heavy swelling and pain in my left knee, all the way down to my heavily swollen left foot.  I finally went to the doctor on 10/07/2025.  Bloodwork showed I had become serum positive for RA.  I then developed swelling and pain in my right knee as well.  My body has been messed up ever since I elected to get the covid vaccinations.  I wish I had never done so. I also developed osteoarthritis as well.  I was in robust health and very active before the injections
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Rheumatoid arthritis, Rheumatoid factor positive
Clinical narrative: First injection: 04/03/2021 led to pain and soreness in upper left arm.  Two days later, swelling and tingling in the area.  Second injection: 04/25/2025 led to pain in my left hip three weeks later, in May 2025.  In June and July 2025, I developed pain and weakness down the left side of my body.  In August 2025, I developed pain and tingling in my left foot.  By mid-September 2025, I developed heavy swelling and pain in my left knee, all the way down to my heavily swollen left foot.  I finally went to the doctor on 10/07/2025.  Bloodwork showed I had become serum positive for RA.  I then developed swelling and pain in my right knee as well.  My body has been messed up ever since I elected to get the covid vaccinations.  I wish I had never done so. I also developed osteoarthritis as well.  I was in robust health and very active before the injections
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, X-ray abnormal
Clinical narrative: First injection: 04/03/2021 led to pain and soreness in upper left arm.  Two days later, swelling and tingling in the area.  Second injection: 04/25/2025 led to pain in my left hip three weeks later, in May 2025.  In June and July 2025, I developed pain and weakness down the left side of my body.  In August 2025, I developed pain and tingling in my left foot.  By mid-September 2025, I developed heavy swelling and pain in my left knee, all the way down to my heavily swollen left foot.  I finally went to the doctor on 10/07/2025.  Bloodwork showed I had become serum positive for RA.  I then developed swelling and pain in my right knee as well.  My body has been messed up ever since I elected to get the covid vaccinations.  I wish I had never done so. I also developed osteoarthritis as well.  I was in robust health and very active before the injections
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Vaccination error
Clinical narrative: Menquadfi (MCV  4) vaccine was administered by mistake.  This nurse was unable to note any adverse reaction due to patient left office prior to discovery of vaccine error.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching, warmth localized to injection site. Swelling/induration and redness covered entirety of left deltoid
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client received several vaccines on that day and forgot to grab the adult Hep B instead of the pediatric box. I attempted to contact client once it was discovered; However, his phone line is disconnected.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Brain fog, Fatigue, Fear, Memory impairment
Clinical narrative: I wrote all of this on the first page under medical issues. It?s quite long?
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb mass, Pruritus
Clinical narrative: Patient states he has small, tiny, itchy bumps on the tops both of his arms. He states that it is not spreading any further and seems to be resolving
Age: 0.67
Sex: F
Vaccine: MMR
Symptoms: Conjunctivitis, Ear infection, Rash, Uveitis
Clinical narrative: Child developed bilateral uveitis and conjunctivitis, requiring antibiotic eye drops. Child also developed full body rash, ear infection requiring amoxicillin.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: The person who received the vaccine experienced redness on their bilateral arms and back as well as itchiness.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Fatigue, Headache
Clinical narrative: Patient had Booster #6  had extremely sore arm, extremely tired, sleepy, sweating, headache for 4 days, chills for 2 days, sore throat, runny nose, not much of an appetite and mild cough
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Oropharyngeal pain, Pain in extremity, Rhinorrhoea, Somnolence
Clinical narrative: Patient had Booster #6  had extremely sore arm, extremely tired, sleepy, sweating, headache for 4 days, chills for 2 days, sore throat, runny nose, not much of an appetite and mild cough
Age: 62.0
Sex: F
Vaccine: MMR, PNC21
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: pt complains of experiencing soreness at injection site for >7 days, says initially the area was red, sore and sort of hard, that has resolved, but is still sore, recommended the patient monitor for a few more days since she states it is getting better, also may use pain reliever of choice and ice may help
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Patient presented at clinic for triage of allergic reaction on 5/27/2025.   HISTORY:  - Patient reported she received the pneumococcal vaccine on Thursday 5/22/2025, which she believes is the cause of her allergic reaction.   - On Saturday night, she developed severe itching on her left arm where the vaccine was administered. Her left arm also became hard, turned red, and developed bumps which were suspected to be hives.    - Patient reported severe itching has persisted since Saturday night. She is unable to wear long sleeve shirts due to this. She took expired Benadryl this morning and has been applying Gold Bond anti-itch lotion which did not help.    ASSESSMENT:  - Left arm visualized. Moderate erythema > 3 inches visualized. No swelling, hives, open wounds, or warmth. Patient denied fevers, chills, shortness of breath, chest pain, nausea, vomiting.    NEXT STEPS: Given allergic reaction, consulted with provider of day. She advised patient to stop taking Benadryl due to potential for drowsiness and instead take cetirizine (Zyrtec) twice daily (once in the morning, once at night) and apply hydrocortisone ointment or cream twice daily (once in the morning, once at night). Patient was also advised to return to the clinic if symptoms worsen despite recommended home treatment with OTC medications.    Patient confirmed understanding and agreed to plan, no further questions or concerns at this time.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: No other information provided. No additional AEs reported; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; Caller reported dose of MMR II leaked out onto patient's arm during administration. Caller states he thinks he did not secure the needle tightly to the PFS.; This spontaneous report was received from a Pharmacist and refers to a(n) 48-year-old female patient.   The patient's medical history, concurrent condition, concomitant therapies were not reported.  On 22-Apr-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y018702, expiration date reported 11-NOV-2026, but upon internal validation established as 26-Apr-2026), with sterile diluent (MERCK STERILE DILUENT) (lot #2031274, expiration date: 10-Dec-2026) for prophylaxis.  During administration, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) leaked out onto the patient's arm. The reporter states he thinks he did not secure the needle tightly to the PFS (not fully secured by the administered Registered Pharmacist) (Incorrect dose administered; Product preparation error; Exposure via skin contact; Device leakage).  No adverse event. The patient was told to return 28 days after event to re-vaccinate.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02793444-02793443 , CLIC number : , ESTAR number : , IRMS number : 500UW00000ZANKIYA5|02052025230031|5173 , Central date : 2025-05-05 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2279609 , MNSC case number : 02793444 , MNSC interaction number : 02793443 , Integration log UniqueID : 500UW00000ZANKIYA5|02052025230031|5173 , Service cloud CaseID : 500UW00000ZANKIYA5
Age: 13.0
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; HCP calling to report PROQUAD administered to a 13-year-old patient on 04/18/2025. Confirmed no symptoms. Unable to collect expiration date for PROQUAD. No other information presented at the moment. No additional AE/PQC.; This spontaneous report was received from a medical Assistant and refers to a(n) 13-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-APR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y013579, expiration date: 03-Feb-2026) administered by Unknown route for prophylaxis, diluted in sterile diluent (MERCK STERILE DILUENT), administered by Unknown route (indication, expiration date, and lot # were not reported) (Product administered to patient of inappropriate age). No adverse event was reported.
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Caller did not report an symptoms/No AE/PQC reported.; Specialist transferred pharmacist reporting an adult patient received a pediatric dose of VAQTA. Caller did not report an symptoms. Permission to contact HCP was granted. No additional information provided. No AE/PQC reported.; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 12-May-2025, the was vaccinated with pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot #Y015027, expiration date: 06-Feb-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (vaccine underdose). Caller did not report any symptoms (no adverse event).
Sex: F
Vaccine: MMR, MMR
Symptoms: Antibody test negative
Clinical narrative: "non-responsive" to MMR-II; patient's MMR titers showed no immunity to measles, mumps, and rubella; patient received 3 doses of MMR-II in a year; This spontaneous report was received from a medical student and refers to a(n) female patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   In 2019, the patient was vaccinated with 3 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (inappropriate schedule of product administration), (lot #N009800, expiration date: 24-Mar-2019), administered by Unknown route for Prophylaxis, diluted in sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported).   In April 2025 (Reported as "about a month ago"), the patient's MMR titers showed no immunity to measles, mumps and rubella, the patient was non-responsive to the vaccine At the reporting time, the outcome of the events was unknown.   Causality assessment was not provided.
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: HCP called to report a husband and a wife who were "non-responsive" to MMR-II. See AE case #02805024 for documentation of the wife and this AE case #02805008 is for documentation of the husband. Patient received 3 doses of MMR-II in the year 2018.; patient's MMR titers showed no immunity to measles, mumps, and rubella; Patient received 3 doses of MMR-II in the year 2018; This spontaneous report was received from a medical student and refers to a male patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   In an unspecified date in 2018, the patient was vaccinated with the first, second, and third dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #N009800, expiration date: 24-Mar-2019)for prophylaxis, diluted with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) (Inappropriate schedule of product administration).  In an unspecified date in April 2025 (also reported as about a month ago), patient's MMR titers showed no immunity to measles, mumps, and rubella. Reporter stated the patient was "non-responsive" to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). At the reporting time, the outcome of the events was unknown.    The causal relationship between the events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not provided.   This is one of two reports from the same reporter.
Age: 11.0
Vaccine: HPV4, HPV4, HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; HCP called to report that a 11 yr old patient received an extra 2nd dose of GARDASIL 9, 18 days after the actual 2nd dose had been administered.  First dose of GARDASIL 9 was administered in January 2024, with the 2nd dose being administered on May 1; HCP called to report that a 11 yr old patient received an extra 2nd dose of GARDASIL 9, 18 days after the actual 2nd dose had been administered.  First dose of GARDASIL 9 was administered in January 2024, with the 2nd dose being administered on May 1; This spontaneous report was received from a Physician and refers to a 11-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On Jan-2024, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), dose number 1, 0.5 mL (lot # and expiration date were not reported).  On 01-May-2025, the patient received a second dose of  with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), 0.5 mL (lot # and expiration date were not reported) which was a delayed 2nd dose not administered according to the schedule in the PI (inappropriate schedule of vaccine administered). On 19-May-2025, the patient received a third dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL (lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). No adverse event was reported.
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptomatic adverse events were reported; patient inadvertently received RECOMBIVAX HB and VAXELIS on the same day; This spontaneous report was received from a Licensed Nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 20-May-2025, the patient inadvertently vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB),, dose number 1, (lot # and expiration date were not reported) and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus(VAXELIS), dose number 1, (lot # and expiration date were not reported) (accidental overdose). No adverse event was reported.; Reporter's Comments:
Age: 13.0
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; HCP called and reported inadvertent administration of a first dose of PROQUAD to a 13-year-old patient on 23MAY2025. Patient demographics not provided. No additional information was known by reporter at time of call. No additional AE/PQC.; This spontaneous report was received from a Physician and refers to a 13-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 23-MAY-2025, at the age of 13 years old, the patient was inadvertently vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), dose number 1, (dose, strength, route of administration, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age) together with sterile diluent (no details provided). No additional adverse event was reported (no adverse event).   Lot # is being requested and will be submitted if received.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia, Vaccination failure
Clinical narrative: Bell-palsy; I thought I went through a stoke; Suspected vaccination failure; shingles included, the only thing I needed was to have the clusters; That weird feeling of the shingles; Fever; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: Bell-palsy) (serious criteria GSK medically significant), stroke (Verbatim: I thought I went through a stoke) (serious criteria GSK medically significant), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles included, the only thing I needed was to have the clusters), weird feeling (Verbatim: That weird feeling of the shingles) and fever (Verbatim: Fever). The outcome of the bell's palsy, stroke, vaccination failure, shingles, weird feeling and fever were not reported.   The reporter considered the bell's palsy to be related to Shingles vaccine. It was unknown if the reporter considered the stroke, vaccination failure, shingles, weird feeling and fever to be related to Shingles vaccine.     The company considered the bell's palsy, stroke and vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, weird feeling and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAY-2025 The case was received from the patient via interactive digital media. The reporter had taken the shingles vaccine.  The reporter thought he/she went through a stoke.  His/her right side of face dropped completely, my eye closed, the pain throughout my right side of my face, and behind my ear it was so painful.  The reporter thought the stroke took place behind the ear.  That weird feeling of the shingles included, the only thing he/she needed was to have the clusters, oh also with fever.  The reporter reported, never again would take a vaccine.  His/her mouth went to the left side of face.  The reporter reported that you need 2 vaccines to get protected for 7 years, he/she was protected for 31/2 years.  It was called Bell-palsy from the shingles vaccine.  This symptoms can last upto 8 months. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Cerebrovascular accident  and Bell's palsy is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: feel some injection site pain that resolved in a couple days; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: feel some injection site pain that resolved in a couple days). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAY-2025 Patient was the reporter and stated that he received the first Shingrix vaccine in February of 2025, unknown arm. Patient felt some injection site pain that resolved in a couple days. For tolerance of 2nd dose please refer linked case.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin discharge
Clinical narrative: Rash fluid discharge itchy; Rash fluid discharge itchy; This non-serious case was reported by a other health professional and described the occurrence of pustular rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension and blood cholesterol abnormal.   On 09-MAY-2025, the patient received Shingrix (intramuscular) .5 ml. On 09-MAY-2025, less than a day after receiving Shingrix, the patient experienced pustular rash (Verbatim: Rash fluid discharge itchy) and itchy rash (Verbatim: Rash fluid discharge itchy). The outcome of the pustular rash and itchy rash were not resolved.   It was unknown if the reporter considered the pustular rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the pustular rash and itchy rash to be related to Shingrix.   Additional Information: GSK receipt date: 23-MAY-2025 The patient was gardening as well rash fluid discharge itchy. No additional information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Ongoing fevers; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Ongoing fevers). The outcome of the fever was resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2025 The pharmacist reported that ongoing fevers in the evening for two weeks following the second dose of Shingrix. The pharmacist reported that this was from a woman in her late 50s/early 60s.  The fever was only in the evenings and lasted for a few weeks before dissipating.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pain, Pruritus
Clinical narrative: Pain; Itching; burning; Redness; This non-serious case was reported by a physician via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (The patient had reported an episode of zoster before receiving the Shingrix doses). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In MAR-2021, the patient received the 2nd dose of Shingrix. In MAY-2025, more than 2 years after receiving Shingrix, the patient experienced pain (Verbatim: Pain), pruritus (Verbatim: Itching), burning sensation skin (Verbatim: burning) and erythema (Verbatim: Redness). The patient was treated with triamcinolone. The outcome of the pain, pruritus, burning sensation skin and erythema were unknown.   It was unknown if the reporter considered the pain, pruritus, burning sensation skin and erythema to be related to Shingrix.     It was unknown if the company considered the pain, pruritus, burning sensation skin and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2025 The reporter, an HCP (physician), stated that he had received two doses of Shingrix, his initial dose in December 2020 and his second in March 2021. The previous night, he had developed pain, redness, itching, and burning on the left side of his upper abdomen, which was about 4 inches wide.  He had applied triamcinolone to the area.  He did not know if it was shingles.  The patient had reported an episode of zoster before receiving the Shingrix doses.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Missed dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 23-MAY-2025 The customer stated that he did not remember if he had received the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have an extreme case; 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have an extreme case). 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 and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAY-2025 This case was reported by the patient via interactive digital media. The patient stated that, according to his/her physician he/she had an extreme case of shingles and patient got the 2 shots. This case was considered as suspected vaccination failure as details regarding 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 the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; now on my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (first time was about 4 years ago). Concurrent medical conditions included stress (job always brought some stress).   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 facial herpes zoster (Verbatim: now on my face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAY-2025 This case was reported by a patient via interactive digital media. Patient went through his/her second round of shingles.  The first time was about four years ago.  Then, he/she got the shots and thought he/she had been protected about two years ago.  Well, it came back, and this time, it was on his/her face.  He/she had completed week one and had hoped it would not last too long.  He/she was fatigued and stressed and could not understand why he/she had been feeling that way, but then it made sense.  His/her job had always brought him/her some stress.  He/she had needed a good, long week off work just to crawl into a dark hole somewhere and sleep.  He/she was not young anymore, so he/she had hoped to get through it quickly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Product use in unapproved indication, Varicella
Clinical narrative: got the shot for it and still here; I had chickenpox 3 times and got the shot for it and still here; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox 3 times). Concurrent medical conditions included immunocompromised (No immunity).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chickenpox (Verbatim: got the shot for it and still here) and product use in unapproved indication (Verbatim: I had chickenpox 3 times and got the shot for it and still here). The outcome of the chickenpox was not resolved and the outcome of the product use in unapproved indication was not applicable.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.     It was unknown if the company considered the chickenpox to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAY-2025 This case was reported by a patient via interactive digital media. The reporter said that he/she in the middle of having it in my head, the worst place.  The patient had chickenpox 3 times and got the shot for it and still here, which led to product used for unapproved indication. No immunity. The doctor said that could get it again.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles on his face and tongue; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: still got shingles on his face and tongue). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAY-2025 This case was reported by a patient's sibling via interactive digital media. The reporter reported that his/her brother had the Shingrix vaccines and still got shingles on his face and tongue which he was still suffering from for over 2 months at this point. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix