chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blister, Fatigue, Vomiting
Clinical narrative: Patient states that the evening of her vaccinations, she experienced vomiting that lasted for several days, in addition to fatigue and blisters on her scalp. She indicated that these symptoms persisted for one week following vaccinations.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITS A VACCINATION
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN PEDIATRIC DOSE AS OPPOSED TO ADULT DOSE OF HEPATITIS A VACCINATION
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: arm pain, patient claims she can not lift arm or stretch arm out with pain, joint pain
Age: 55.0
Sex: F
Vaccine: JEV1, TYP
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Nausea, Vomiting
Clinical narrative: on 5-30-25 the patient contacted her doctor and stated that she had nausea and vomiting and dizziness. Her right arm, leg, and foot felt numb and she felt like her foot was slapping when she walked. She reported to the doctor that she was better on 6-2-25
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitus at injection site diagnosed by PCP requiring antibiotics and steroid. Belly rash after 48 hours.  Prednisone and Clindamycin prescribed.  Sore injection site within hours of injection. Fever, chills, nausea began 12 hours after injection and lasted 48 hours. 24 hours after injection, injection site was red(1"), swollen, hot, painful. Redness was approximately 1". By hour 48, redness was 2". By hour 72, redness was 3". Saw my PCP at hour 72 and he said it is infected and prescribed me antibiotics and steroids.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia, Rash
Clinical narrative: Cellulitus at injection site diagnosed by PCP requiring antibiotics and steroid. Belly rash after 48 hours.  Prednisone and Clindamycin prescribed.  Sore injection site within hours of injection. Fever, chills, nausea began 12 hours after injection and lasted 48 hours. 24 hours after injection, injection site was red(1"), swollen, hot, painful. Redness was approximately 1". By hour 48, redness was 2". By hour 72, redness was 3". Saw my PCP at hour 72 and he said it is infected and prescribed me antibiotics and steroids.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Influenza like illness, Injection site erythema, Pain
Clinical narrative: Cellulitus at injection site diagnosed by PCP requiring antibiotics and steroid. Belly rash after 48 hours.  Prednisone and Clindamycin prescribed.  Sore injection site within hours of injection. Fever, chills, nausea began 12 hours after injection and lasted 48 hours. 24 hours after injection, injection site was red(1"), swollen, hot, painful. Redness was approximately 1". By hour 48, redness was 2". By hour 72, redness was 3". Saw my PCP at hour 72 and he said it is infected and prescribed me antibiotics and steroids.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Cellulitus at injection site diagnosed by PCP requiring antibiotics and steroid. Belly rash after 48 hours.  Prednisone and Clindamycin prescribed.  Sore injection site within hours of injection. Fever, chills, nausea began 12 hours after injection and lasted 48 hours. 24 hours after injection, injection site was red(1"), swollen, hot, painful. Redness was approximately 1". By hour 48, redness was 2". By hour 72, redness was 3". Saw my PCP at hour 72 and he said it is infected and prescribed me antibiotics and steroids.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin reaction, Tenderness
Clinical narrative: Pt showed up to pharmacy with large read , swollen area on left arm. tender to the touch
Age: 57.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: Full body itchy rash with small blisters, started 11 days after vaccination and lasted for several weeks. Did not require treatment.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: ON 05-23-25, SHINGRIX VACCINE WAS ADMINISTERED BY RPH. PT HAD CONTACTED RPH: IN REGARDS TO HER CONCERN OF EXPERIENCING PAIN ALONG LEFT SHOULDER JOINT AREA,  AND THE INABILITY TO LIFT HER LEFT ARM ON 5-23-25 AROUND 5:45 PM.  RPH HAD ADVISED HER MAY BE POSSIBLE SIDE EFFECT OF MUSCLE TENDERNESS AT INJECTION SITE, AND TO APPLY A COLD COMPRESS AND TAKE OTC IBUPROFEN IF TOLERATED.  RPH, HAD ADVISED PT IF PAIN BECOMES SEVERE TO IMMEDIATELY CONTACT HER MD AND SEEK MEDICAL ATTENTION.  ON 5-24-25, PT WAS PRESCRIBED MEDROL DOSE PACK BY HER NP.  PRESCRIBER BELIEVES THAT VACCINE WAS ADMINISTERED TOO HIGH UP THE SHOULDER REGION IN THE SHOULDER CAPSULE CAUSING HER CHRONIC PAIN, LIMITED SHOULDER MOVEMENT, AND NERVE PAIN.  PT HAS BEEN IN CHRONIC PAIN, AND WAS UNABLE TO SIGNIFICANTLY MOVE HER LEFT ARM FROM 5-23-25 TO 5-28-25. ON 5-28-25, PT WAS ALSO COMPLAINING OF SHARP PAIN RADIATING DOWN HER LEFT ARM.  AS OF 6-2-25, PT INDICATED SHE IS ABLE TO MOVE HER SHOULDER, AND PAIN HAS SUBSIDED BUT NOT COMPLETELY.  HOWEVER, SHE IS NOT ABLE TO PLACE ANY RESISTANCE (WEIGHT) ALONG THE LEFT ARM/ SHOULD REGION.  SHOULDER IS STILL SORE.
Age: 21.0
Sex: F
Vaccine: TYP
Symptoms: Blood test, Dyspnoea, Hypersensitivity, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Severe allergic reaction, onset approximately 5-7 minutes following ingestion of the oral capsule. Symptoms began with tingling in the mouth/throat, and quickly progress to difficulties breathing within a minute. EpiPen was administered quickly, less than 5 minutes after the reaction started. Patient was conscious and showing minimal symptoms when ambulance arrived. Patient was transferred a local ER, and was given intravenous methylprednisone, diphenhydramine, and fomatidine. Patient was monitored for approximately 4 hours, and no further events or complications occurred. Patient was sent home with a 5-day course of prednisone, and instructions to take OTC Benadryl as needed for at least 5 days.
Age: 59.0
Sex: M
Vaccine: PNC21
Symptoms: Fatigue
Clinical narrative: Excessive fatigue
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Chest discomfort, Herpes zoster
Clinical narrative: Had 2 dots of Shingles awhile back in Feb./Mar. 2025 after taking Zoster vaccine many years ago.  Dr. suggested getting a 3rd shot and when I went to pharmacy, they said I never had Shingrix and should get 2 shots, 2nd after 2-6 months.  About 2 weeks after getting shot I felt that same pimple/dot on my chest that I had Shingles back in Feb.Mar. and it feels the same discomfort.  It is still there and uncomfortable, but 2nd dot has not turned up as yet.  This seems like it should not happen and when researching on internet was directed to submit this adverse reaction but getting Shingles in same spot 2nd time after taking dose 1 of Shingrix
Age: 70.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Contusion, Muscle spasms
Clinical narrative: pad of right thumb black and blue; pain associated with spasm; Spasm in right thumb; This non-serious case was reported by a consumer via call center representative and described the occurrence of spasms in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4B22T) for prophylaxis.   On 29-MAY-2025, the patient received Arexvy (intramuscular, left arm) .5 ml. On 29-MAY-2025, 5 min after receiving Arexvy, the patient experienced spasms (Verbatim: Spasm in right thumb) and muscle pain (Verbatim: pain associated with spasm). On 30-MAY-2025, the patient experienced skin discoloration (Verbatim: pad of right thumb black and blue). On 29-MAY-2025, the outcome of the spasms and muscle pain were resolved. The outcome of the skin discoloration was not resolved.   It was unknown if the reporter considered the spasms, skin discoloration and muscle pain to be related to Arexvy.     It was unknown if the company considered the spasms, skin discoloration and muscle pain to be related to Arexvy.   Additional Information: GSK receipt date: 30-MAY-2025 The patient was vaccinated with Arexvy on 29th May 2025 in the left arm. Within 5 minutes she felt a spasm in her right thumb. The spasm resolved fairly quickly but reported today the pad of her right thumb is black and blue. There was some pain associated with the spasm. No further information was obtained/provided.
Age: 70.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Muscle spasms, Pain, Skin discolouration
Clinical narrative: pad of right thumb black and blue; pain associated with spasm; Spasm in right thumb; This non-serious case was reported by a consumer via call center representative and described the occurrence of spasms in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4B22T) for prophylaxis.   On 29-MAY-2025, the patient received Arexvy (intramuscular, left arm) .5 ml. On 29-MAY-2025, 5 min after receiving Arexvy, the patient experienced spasms (Verbatim: Spasm in right thumb) and muscle pain (Verbatim: pain associated with spasm). On 30-MAY-2025, the patient experienced skin discoloration (Verbatim: pad of right thumb black and blue). On 29-MAY-2025, the outcome of the spasms and muscle pain were resolved. The outcome of the skin discoloration was not resolved.   It was unknown if the reporter considered the spasms, skin discoloration and muscle pain to be related to Arexvy.     It was unknown if the company considered the spasms, skin discoloration and muscle pain to be related to Arexvy.   Additional Information: GSK receipt date: 30-MAY-2025 The patient was vaccinated with Arexvy on 29th May 2025 in the left arm. Within 5 minutes she felt a spasm in her right thumb. The spasm resolved fairly quickly but reported today the pad of her right thumb is black and blue. There was some pain associated with the spasm. No further information was obtained/provided.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: pharmacist who said a patient received a dose of GARDASIL 9 "last August" and came back to get his second shot of the series last week.; no adverse event; This spontaneous report was received from a pharmacist and refers to a 29-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   In August 2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection; In May 2025, also reported as last week, the patient came back to get his second dose of  Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) ( for both doses, lot #, dose, route of administration, anatomical location of vaccine and expiration date were not reported) for  Prophylaxis (inappropriate schedule of vaccine administered). No additional adverse event was reported.
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: VARIVAX and  PROQUAD. AE was filed as both vaccines contained varicella component; intended to provide patient with VARIVAX and MMR II.; No symptomatic events reported; This spontaneous report was received from a nurse practitioner referring to a patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was intended to receive varicella virus vaccine live (oka/merck)(VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, but on 20-May-2025, was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strengths, specific dosages, dose numbers, routes of administration, anatomical sites of application, lot numbers and expiration dates were not provided). AE was filed as both vaccines contained varicella component. No symptomatic events.  Lot # is being requested and will be submitted if received.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse confirmed the patient has not reported any medical concerns or symptoms after being administered the improperly stored dose of VARIVAX.; Nurse calling with a report of an adverse event regarding an improperly stored and administered dose of VARIVAX.  Nurse stated that the VARIVAX was involved in a temperature excursion beginning on 5/8/2025 and was administered to a patient on 5/16/20; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   Beginning on 08-MAY-2025, the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was involved in a temperature excursion, then, on 16-May-2025, the patient was vaccinated with this vaccine, which was  the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003767, expiration date: 30-Jan-2027), 0.5 mL administered by Unknown route as prophylaxis. The vaccine was reconstituted with a Sterile diluent (lot# and expiration date not reported.  Nurse confirmed the patient has not reported any medical concerns or symptoms after being administered the improperly stored dose of VARIVAX. No additional information provided. No additional AE/PQC.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Infant irritability, Pyrexia, Rash
Clinical narrative: Subjective fever, fussiness & generalized rash starting 5/29/25
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Rash, Rash erythematous
Clinical narrative: Patient was receiving his 4-year vaccines that included Kinrix (Dtap+IPV). I administered that vaccine in his left deltoid, then moved on and gave another 2 vaccines in his right deltoid area, 11:50am. He was crying and hugging his mom. I left the room, came over to my desk, set my vaccines down, and went and picked him some stickers out. When I returned, patient was a rash coming from under his left Band-Aid and long his left side, 11:52am. I went out and got my provider. I informed her I believed he was having a reaction to the Kinrix vaccine. She immediately came in and did an evaluation, and gave me a verbal order for diphenhydramine 5ml and 6ml of Prednisolone. I administered those medications and gave patient some water and a toy to play with while we waited 30 minutes for observation. I checked on him a few times over the 30 minutes and noted the redness was clearing up. At the 25-minute mark, I went in and rechecked his BP and Heart rate. Gave provider the notice to clear patient so he may leave.
Age: 50.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt called and said they were experiencing redness at injection site and itching. Patient did state they took Tylenol & Ibuprofen for pain. Patient did say they would go to doctor's office for evaluation.
Age: 10.0
Sex: F
Vaccine: FLU3, IPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner and refers to a 8-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. Historical vaccines included Havrix (Hepatitis a vaccine inact), Fluzone (Fluconazole), and Tdap (Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid) (vaccinated at 02-FEB-2025).  On 12-Mar-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X022411, expiration date: 05-Jun-2025), administered by Intramuscular route, reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported); the first dose of Flulaval (Influenza vaccine inact split 3v) (lot #4LM54, expiration date: 30-Jun-2025) (1 dose), administered by Intramuscular route;  Ipol (Polio vaccine inact 3v (Vero)) (lot #XC891H, expiration date: 31-Oct-2024) (1IPOL- B POV), administered by Intramuscular route. All for prophylaxis.  On 09-Apr-2025, at compliance visit, upon review by state, temperature excursion was noted from 03-Mar-2025 to 10-Mar-2025 (product storage error). Upon further investigation and review by the DDL manufacturer, it was noted as a "glitch" "most likely caused by an electronical interference". The VFC program advised revaccination and that process was currently in progress with the patients involved. No adverse event was reported.  This is one of several cases from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : (redacted)@merck.com , Index date : 2025-05-14 , MNSC number : 02785949 , CLIC number : , ESTAR number : , IRMS number : Patient, Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope; This spontaneous report was received from a Nurse via company employee and refers to a(n) 11-year-old female patient. 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, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), administered for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported).  On 23-May-2025 (also reported as after her first dose of the GARDASIL 9 vaccine), the patient experienced syncope.   At the reporting time, the outcome of syncope was unknown. The action taken with suspect vaccine was not applicable.   The causal relationship between the event of syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) was unknown/not reported/not provided.    Upon internal review, the event of syncope was determined to be medically significant.   Additional information were not expected.
Vaccine: MMRV, MMRV
Symptoms: Wrong product administered
Clinical narrative: Caller stated patient has not reported any symptoms.; HCP calling to report a patient inadvertently received and PROQUAD vaccine instead of MMRII and VARIVAX.; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 02-JUN-2025, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), administered as prophylaxis (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported) and reconstituted with sterile diluent (BAXTER STERILE DILUENT) (lot number and expiration date were not reported), instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine Live (M-M-R II) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (Wrong product administered).  The patient had not reported any symptoms after the administration.
Sex: M
Vaccine: RSV
Symptoms: Bone marrow transplant
Clinical narrative: Bone marrow transplant; This serious case was reported by a pharmacist via patient support programs and described the occurrence of bone marrow transplant in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced bone marrow transplant (Verbatim: Bone marrow transplant) (serious criteria clinically significant/intervention required). The outcome of the bone marrow transplant was unknown.   It was unknown if the reporter considered the bone marrow transplant to be related to Arexvy.     The company considered the bone marrow transplant to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 17-APR-2025 The patient received Arexvy vaccine previously, but recently had a bone marrow transplant.  Their doctor recommended to repeat vaccines. The patient tried to check to readminister Arexvy per doctor order but came back denied.  The reporter asked about a prior authorization for this situation and would like a call back for assistance.  The Quality Auditor located the note in this case from the email and advised that this was an adverse event that needs to be reported.; Sender's Comments: Bone marrow transplant is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Product administered at inappropriate site, Tendonitis
Clinical narrative: spot in arm which was visibly lumpy and harder; spot in arm which was visibly lumpy and harder; suspected tendinitis; The pharmacist thought that the vaccine was administered lower than it should have been; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a female patient who received Herpes zoster (Shingrix) (batch number k2bb7, expiry date 30-JAN-2027) for prophylaxis.   In FEB-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site lump (Verbatim: spot in arm which was visibly lumpy and harder), injection site induration (Verbatim: spot in arm which was visibly lumpy and harder), tendonitis (Verbatim: suspected tendinitis) and vaccine administered at inappropriate site (Verbatim: The pharmacist thought that the vaccine was administered lower than it should have been). The outcome of the injection site lump and tendonitis were unknown and the outcome of the injection site induration was not reported and the outcome of the vaccine administered at inappropriate site was not applicable.   It was unknown if the reporter considered the injection site lump, injection site induration and tendonitis to be related to Shingrix.     It was unknown if the company considered the injection site lump, injection site induration and tendonitis to be related to Shingrix.   Additional Information: GSK receipt date: 27-MAY-2025 The pharmacist stated that a patient received her first dose of Shingrix in February 2025. After her dose, she developed a spot in her arm which was visibly lumpy and harder than normal. The pharmacist thought that the vaccine was administered lower than it should have been which led to vaccine administered at inappropriate site. It may be tendinitis.
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; outbreak of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (received single vaccine 20 years ago).   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: outbreak of shingles). The patient was treated with valaciclovir hydrochloride (Valtrex). 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.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she had been fortunate not to ever get a severe case of shingles, but the reporter chronically get shingles. The patient had an ongoing prescription for Valtrex and begin taking them at first sign. The patient guessed that in the past 3 years the patient had gotten the at least 20 times. The reporter has had the single vaccine about 20 years ago, and also the double vaccine a few years ago. Usually before an outbreak, the reporter felt run down, headache for a few days. Then surprise, the patient got another breakout. The reporter was on a trial to take a Valtrex every day and see if that helps. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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, 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: Arthralgia, Herpes zoster, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: the site is raised red and hurts a lot; the site is raised red and hurts a lot; I feel feverish; joint soreness / my ankle on the side I had shingles rash really really hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Had shingles over 2 years ago).   In MAY-2025, the patient received the 1st dose of Shingles vaccine. On an unknown date, 24 hrs after receiving Shingles vaccine, the patient experienced fever (Verbatim: I feel feverish), injection site erythema (Verbatim: the site is raised red and hurts a lot), injection site pain (Verbatim: the site is raised red and hurts a lot) and soreness of joint (Verbatim: joint soreness / my ankle on the side I had shingles rash really really hurts). The outcome of the fever, injection site erythema, injection site pain and soreness of joint were not resolved.   It was unknown if the reporter considered the fever, injection site erythema, injection site pain and soreness of joint to be related to Shingles vaccine.     It was unknown if the company considered the fever, injection site erythema, injection site pain and soreness of joint to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine less than 24 hours ago. The first one. The patient have had shingles over 2 years ago. Today the site was raised red and hurts a lot & feel feverish. Now the patient's ankle on the side he/she had shingles rash really really hurted. The reporter wanted to know if this was common that the joint soreness a side effect of shingles vaccine.
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: the site is raised red and hurts a lot; the site is raised red and hurts a lot; I feel feverish; joint soreness / my ankle on the side I had shingles rash really really hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Had shingles over 2 years ago).   In MAY-2025, the patient received the 1st dose of Shingles vaccine. On an unknown date, 24 hrs after receiving Shingles vaccine, the patient experienced fever (Verbatim: I feel feverish), injection site erythema (Verbatim: the site is raised red and hurts a lot), injection site pain (Verbatim: the site is raised red and hurts a lot) and soreness of joint (Verbatim: joint soreness / my ankle on the side I had shingles rash really really hurts). The outcome of the fever, injection site erythema, injection site pain and soreness of joint were not resolved.   It was unknown if the reporter considered the fever, injection site erythema, injection site pain and soreness of joint to be related to Shingles vaccine.     It was unknown if the company considered the fever, injection site erythema, injection site pain and soreness of joint to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine less than 24 hours ago. The first one. The patient have had shingles over 2 years ago. Today the site was raised red and hurts a lot & feel feverish. Now the patient's ankle on the side he/she had shingles rash really really hurted. The reporter wanted to know if this was common that the joint soreness a side effect of shingles vaccine.
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Headache, Lacrimation increased, Pain
Clinical narrative: headache; sinus pressure; watery eyes; bodyaches; ears pain; chills; sinus infection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, less than a week after receiving Shingrix, the patient experienced headache (Verbatim: headache), sinus pressure (Verbatim: sinus pressure), watering eyes (Verbatim: watery eyes), general body pain (Verbatim: bodyaches), ear pain (Verbatim: ears pain), chills (Verbatim: chills) and sinus infection (Verbatim: sinus infection). The outcome of the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection were not resolved.   It was unknown if the reporter considered the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection to be related to Shingrix.     It was unknown if the company considered the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The reporter stated that he/she had first dose of Shingrix vaccine two days ago and experienced side effects headache, sinus pressure, watery eyes, body aches, chills, no fever, headache and ears pain.  The patient stated he/she do not know if it is sinus infection or injection side effect its been 2 days since received first dose The patient enquired how long do side effect last
Vaccine: VARZOS
Symptoms: Paranasal sinus discomfort, Sinusitis
Clinical narrative: headache; sinus pressure; watery eyes; bodyaches; ears pain; chills; sinus infection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, less than a week after receiving Shingrix, the patient experienced headache (Verbatim: headache), sinus pressure (Verbatim: sinus pressure), watering eyes (Verbatim: watery eyes), general body pain (Verbatim: bodyaches), ear pain (Verbatim: ears pain), chills (Verbatim: chills) and sinus infection (Verbatim: sinus infection). The outcome of the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection were not resolved.   It was unknown if the reporter considered the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection to be related to Shingrix.     It was unknown if the company considered the headache, sinus pressure, watering eyes, general body pain, ear pain, chills and sinus infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The reporter stated that he/she had first dose of Shingrix vaccine two days ago and experienced side effects headache, sinus pressure, watery eyes, body aches, chills, no fever, headache and ears pain.  The patient stated he/she do not know if it is sinus infection or injection side effect its been 2 days since received first dose The patient enquired how long do side effect last
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Knocked me on my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (patient received 1st dose on unknown date).   On 01-JUN-2025, the patient received the 2nd dose of Shingles vaccine. In JUN-2025, less than a day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Knocked me on my butt). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 02-JUN-2025 This case was reported by a patient via interactive digital media.  Patient stated that just got second shot a day before reporting, patient stated that it knocked on butt. 1st one didn't. Glad it was only once.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have the shingles in my ride side of my head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have the shingles in my ride side of my head). The patient was treated with valacyclovir. The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAY-2025 This case was reported by a patient via interactive digital media. The patient took the Shingles shot but just found out he/she had the shingles in his/her ride side of head so patient guessed that the shot did not work, the physician put him/her on valacyclovir for 7 days.  The reporter was hoping since he/she had the shot, he/she would have a mild case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Age: 0.42
Sex: M
Vaccine: DTAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives on abdomen and hives at vaccine site
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC20
Symptoms: Erythema, Injection site pain, Laboratory test, Lip swelling, Pyrexia
Clinical narrative: Mother refers that the baby has hives on the face, high fever, swollen lips and one side of the face is red and hot to the touch.  A lot of pain at the site of administration.
Age: 1.83
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC20
Symptoms: Skin warm, Urticaria
Clinical narrative: Mother refers that the baby has hives on the face, high fever, swollen lips and one side of the face is red and hot to the touch.  A lot of pain at the site of administration.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Anaphylactic reaction, Swelling face, Throat tightness, Urticaria
Clinical narrative: INCIDENT 1- 5/28: Full- blown hives on entire body, throat closing up - anaphylaxis -- Went to ER & received EPI-Pen and IV with Benadryl, steroid, Pepcid and etc. Held for observation.   INCIDENT 2 -  5/31: Hives on entire body, throat closing up, face swollen, and lips extremely swollen - anaphylaxis. Gave myself Epi-Pen and went to ER. Had same treatment as Incident 1.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Depressed mood, Feeling hot, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Varicella- states he felt warm (low grade fever) did not measure temperature because he did not have a thermometer. Site was warm, itchy, red, states it felt like he was very sick. No nausea/vomiting. States he felt so down he almost called out x 2 d/t this. Symptoms lasted x 7 days
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise
Clinical narrative: Varicella- states he felt warm (low grade fever) did not measure temperature because he did not have a thermometer. Site was warm, itchy, red, states it felt like he was very sick. No nausea/vomiting. States he felt so down he almost called out x 2 d/t this. Symptoms lasted x 7 days
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-MAY-2025 This case was reported by a patient via interactive digital media. Patient stated that the first one made them so sick that they asked their doctor if they had to take the second because they had shingles previously and reaction to the shot was worse than the Shingles.
Age: 80.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Mass, Pain, Pyrexia
Clinical narrative: redness, fever, soreness, and knot in arm appeared a week after receiving vaccine
Age: 17.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Syncope
Clinical narrative: After the client received her vaccines, she was walking back to the lobby when she fainted. Client was slowly lowered to the ground to avoid injury. Respirations were even and shallow. Ammonia inhalant applied, client responded immediately, was able to answer questions and walk to a chair in the waiting room. 911 had been contacted and arrived on scene, client mother elected for client to go to the hospital for further treatment and evaluation.
Age: 1.08
Sex: M
Vaccine: DTPPVHBHPB, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was seen by Dr. on 6/2/2025 for his 1 year WCC. He was scheduled to receive MMR, Varicella and Vaxelis vaccines. He was inadvertently given MMRV, Varicella and Vaxelis vaccines by staff who was working with Dr. this day. Staff noted the error and immediately informed the clinical supervisor. Clinical services, Program Manager and Dr. were also notified. Telephone call to family to explain incident done as recommended by provider. No adverse effects noted at this time. Family will reach out with any questions, concerns or needs.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Red rash that started at right deltoid approx 36 hours after vaccine administration. Rash has continued to spread over 48 hours down anterior and medial bicep. Rash is itchy. Deltoid muscle is sore. No joint involvement. Encouraged Ibuprofen, antihistamine, continued observation, and follow up if worsening/failing to improve over the next 48 hours.
Age: 25.0
Sex: F
Vaccine: HEPA, TDAP, YF
Symptoms: Dizziness, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Client called 5 hours after receiving vaccines and reported redness, swelling, itchiness at site of yellow fever administration, left arm subcutaneous. Client also reported feeling dizzy intermittently. Client denied any respiratory symptoms. Client was instructed to take oral benadryl and apply ice to the site and to call if symptoms worsened or changed. This writer reached out to client following day at 0830, approximately 22 hours after vaccine administration, client reported benadryl helped, swelling decreased. Client reports site is still slightly swollen and itchy. Client instructed to continue to monitor and call back if anything changes.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There was no adverse event. Child's parent did not have any issues with Child after receiving extra dose of IPV.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine  expired on 3/20/25. Vaccine given 5/15/25. Discovered event on reporting 6/3/25. No adverse effects noted.
Age: 19.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dyspnoea, Lethargy, Lip swelling, Pruritus, Tachypnoea
Clinical narrative: shortly after vaccination, pt was found sitting on ground outside of clinic complaining of hives, itching and shortness of breath. pt was assisted into building for assessment and treatment. pt appeared lethargic, tachypneic, lips appeared swollen. based on symptoms and history, IM Epinephrine autoinjector pin was administered into the right thigh through the pts clothing. vitals assessed, lung sounds auscultated as clear in all fields.  medical provider on site came and assessed and determined that the pt was stable for transport POV to the nearest hospital for further evaluation and treatment (no EMS was needed). pt was assisted into POV and accompanied by clinic staff (EMT/RN and MD) to the hospital were the pt was registered and triaged by hospital staff and care was transferred to facility staff.
Age: 19.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: shortly after vaccination, pt was found sitting on ground outside of clinic complaining of hives, itching and shortness of breath. pt was assisted into building for assessment and treatment. pt appeared lethargic, tachypneic, lips appeared swollen. based on symptoms and history, IM Epinephrine autoinjector pin was administered into the right thigh through the pts clothing. vitals assessed, lung sounds auscultated as clear in all fields.  medical provider on site came and assessed and determined that the pt was stable for transport POV to the nearest hospital for further evaluation and treatment (no EMS was needed). pt was assisted into POV and accompanied by clinic staff (EMT/RN and MD) to the hospital were the pt was registered and triaged by hospital staff and care was transferred to facility staff.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Vaccine expired 3/1/25. Vaccine administered 5/15/25. Event found after running administration report 6/3/25.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blindness, Dizziness, Hypotonia, Posture abnormal
Clinical narrative: About 10 minutes after receiving Bexsero patient  was sitting in waiting room and began to feel lightheaded and said "everything was going black". Provider responded and patient become limp with some inward turning of right hand and foot. Episode lasted approximately 5 seconds and patient opened eyes, pupils were dilated but responding to provider movement, able to locate where she was and state her name. Pulse ox was applied to finger which revealed normal pulse ox level of 97% and HR of 48. Two minutes later she felt nauseous and was helped to the bathroom but did not have any emesis. Five minutes after the event she was helped to an exam room, laid flat and elevated legs. After 2 minutes of legs elevated patient stated she was feeling better. She was given water and laid flat for 15 minutes. She sat up and BP was checked and found to be 98/58 (BP upon arrival to office before vaccine was 108/60). She sat up for another 15-20 minutes, BP was rechecked and found to be 100/60. Her color returned to normal, she stated she felt better, and was able to ambulate self to parent's private vehicle and go home.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Tremor
Clinical narrative: She became dizzy, developed headache, and was shaky starting 4 hr after vaccination and this continued until this morning though symptoms are now improving.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: felt burning at time of injection and had burning redness pain at site of injection
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: APPROXIMATELY 5 MINUTES AFTER INJECTION, PATIENT BECAME PALE AND FAINTED.  SHE VERBALIZED FEELING DIZZY JUST PRIOR TO EPISODE.  SHE RETURNED TO BASELINE 1 MINUTE LATER.  SHE REMAINED IN THE OFFICE 30 MINUTES AFTER EPISODE.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Haemorrhage, Injection site swelling
Clinical narrative: Severe swelling at injection site. Patient was bleeding more than normal after administration. Patient was given a cold pack to apply. After 10 to 15 minutes the swelling was noticeably reduced.
Age: 11.0
Sex: M
Vaccine: MENB, TD, VARCEL
Symptoms: Headache, Injection site swelling, Pyrexia
Clinical narrative: Hight temperature 104, bad headache and swollen areas around the shots. They did not know which shot he had a reaction from so they could not give him anymore of those shots if needed.