chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope
Clinical narrative: Patient fainted within an hour of vaccines.  Patient reported she had not eaten/drank since breakfast and it was after 2pm.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Vomitting multiple times, coming from childs mouth and nose. sOUNDED LIKE A BURST WATER PIPE IN CHILD BEFORE THE CHILD REGURGITATED.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Pollakiuria
Clinical narrative: Increased sweating and increased urination frequency that did not start until day 3 and continued through today (Day 7.) He denies fever of loss of blood sugar control and not high at the moment but most recent A1C, 3 months ago, was 9.2 mg/dl.  Advised to call primary care provider as symptoms could also be due to UTI, especially with SGLT2 inhibitor and average blood sugar 217 based on most recent A1c. Increased urination and sweating from high blood sugar, which he denies, can also cause increased urination and sweating. He was advised that we would fill out VAERS to document symptoms, but that they were likely due to another cause. Patient also said no redness, warmth or irritation around injection site that might be signs of cellulitis. He called PCP after we spoke and reported symptoms message to her staff.
Age: 51.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient had Redness, swelling, and itching encircling upper right arm.  Notified pharmacy on evening of 6/23/25.  Swelling had gone down some, but the site still itched.  Advised patient to take oral benadryl 25mg every 6 hours as needed and to notify physician or urgent care if swelling increased of patient experienced shortness of breath.
Age: 22.0
Sex: M
Vaccine: IPV
Symptoms: Loss of consciousness
Clinical narrative: Following immunization, patient passed out. Patient came to shortly after and felt fine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Client was supposed to receive Meningococcal B vaccine- not Meningococcal conjugate vaccine. The client did not report any adverse reactions.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site rash, Malaise, Myalgia
Clinical narrative: Patient described a "speckled" rash that looked like chicken pox around the area of the injection site.  Rather severe pain extending up through shoulder and neck. General malaise, muscle pain, feeling of being unwell.  No fever noted.  All symptoms occurring within 24 hours of vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Rash vesicular
Clinical narrative: Patient described a "speckled" rash that looked like chicken pox around the area of the injection site.  Rather severe pain extending up through shoulder and neck. General malaise, muscle pain, feeling of being unwell.  No fever noted.  All symptoms occurring within 24 hours of vaccination.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given kinrix, which was outside the approved age range for the patient. No adverse event happened to the patient.
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Paraesthesia
Clinical narrative: sweating a lot, weird feeling, cold chill down to get, tingly feeling.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, PNC20, DTAP, MMRV, PNC20
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccines were given according to record.  The child had vaccines at pediatrician's office on 04-08-25 but were not reported until 5-14-25.  Dtap was given too early, MMRV was given as too many doses. Father of the child brought child to clinic on 5-8-25.  Mother was called to let her know what had happened-she reported that child was fine and had no problems after the vaccines he received on 5-8-25.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV, PNC20, DTAP, MMRV, PNC20
Symptoms: Extra dose administered
Clinical narrative: Vaccines were given according to record.  The child had vaccines at pediatrician's office on 04-08-25 but were not reported until 5-14-25.  Dtap was given too early, MMRV was given as too many doses. Father of the child brought child to clinic on 5-8-25.  Mother was called to let her know what had happened-she reported that child was fine and had no problems after the vaccines he received on 5-8-25.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Rash
Clinical narrative: On June 20, 2025, the young woman was given the first dose of HPV and the second dose of MCV (MENVEO) in her right arm. On Saturday, she had a rash around her eyes and different areas of the face, behind her right ear and on her right arm. She had no fever or difficulty breathing. Her mother gave her oral Benadryl and called us on Monday and told us what happened. I told her to bring her to the clinic. She brought her to me today, June 24, and a mild rash was still observed in those areas.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Periorbital swelling, Underdose, Vomiting
Clinical narrative: Pt was administered Rotavirus. Pt started to vomit after a portion of the dose was administered. Per medical assistant half of the dose was administered. Pt started to vomit x1 and puffy eyes were noted. Upon arrival vitals were monitored. Pulse: 155, O2: 100%. No cyanosis, wheezing per provider. Per provider EMS was called. Pt was taken to Hospital to continue monitoring. Pt was discharged from Hospital the same day.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Patient had dizziness for about 20 minutes. She stated she usually she has dizziness right after receiving a vaccine.  called the patient 2 hours later and she stated she was feeling better
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Joint noise, Mobility decreased
Clinical narrative: Patient stated she "could not hardly move her right arm for 5 days after receiving the vaccine."  Also stated it "it still pops and cracks"
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Patient received his vaccination shots on Monday, June 16, 2025.His left arm, NOTED THE NIGHT OF 6/18/2025, where KINRIXt was administered, appeared very red and is suspected to be a reaction .The guardian first noticed the redness while giving him a bath. Later that day, after returning home, Patient was observed itching his neck and his back was covered in hives. A photograph of the reaction was taken before administration of Benadryl. Patient had a prior similar hive episode under his eyes a couple of weeks ago. Benadryl was given by the guardian with noted improvement of the hive appearance. Left arm at vaccine site with erythema raised,  hive reaction about 1 1/2 inch in diameter, slightly warm to touch back with large erythematous area of hives central, no raised areas or warmth noted no other hives noted on exam. Continue Benadryl every six hours to manage the hives.Apply cool compresses and use oatmeal baths to relieve itching.Monitor for any worsening symptoms including increased swelling, joint swelling, or systemic involvement.Reassure that this reaction is not severe and does not contraindicate future tetanus vaccination when indicated.Instruct the guardian to report any new or worsening symptoms promptly
Age: 60.0
Sex: M
Vaccine: JEV1
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Diffuse upper extremity itching x ~4 days with 12 hours of rash or hives on abdomen .  Resumed cetirizine for seasonal allergies and improved.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen, slightly painful lymph nodes around the collar bone  on the same side as the injection  site(left).
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Patient received vaccine on 6/18/25. Was achy and weak in arm for 3-4 days. Then on 6/23/25, patient reports redness and tenderness in most of her right arm. Was very concerned and made an appointment to follow up with physician. Was given antibiotics per patient on 6/23/25 and on 6/24/25 reported swelling reduced and improvement in arm.
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: L ANTERIOR MID THIGHT AT INJECTION SITE IS RED TENDER AND INDURATED. A PATCH OF 2 INCHES BY 1.5 INCHES WITH ERYTHEMA. R THIGH ONLY INDURATED AT INJECTION SITE.
Age: 1.17
Sex: M
Vaccine: HIBV, PNC20, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Right thigh (PCV-20) had a hard sensitive lump at the injection site, was slightly raised/swollen, and hot to the touch. Parent stated it bled a bit more than usual upon injection. Upon follow up on 06.24.2025, it is still red and has a small lump, along with it still being mildly sensitive. Left thigh (HIB) was sensitive to the touch and mildly raised. Upon follow up on 06.24.2025. It is still a little red and warm to the touch, but is no longer sensitive. Child had a slight fever for roughly 24 hours, and was given motrin on 06.20.2025 and 06.21.2025.  They went to their primary care physician determining it an adverse reaction.
Age: 1.17
Sex: M
Vaccine: HIBV, PNC20, VARCEL
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Right thigh (PCV-20) had a hard sensitive lump at the injection site, was slightly raised/swollen, and hot to the touch. Parent stated it bled a bit more than usual upon injection. Upon follow up on 06.24.2025, it is still red and has a small lump, along with it still being mildly sensitive. Left thigh (HIB) was sensitive to the touch and mildly raised. Upon follow up on 06.24.2025. It is still a little red and warm to the touch, but is no longer sensitive. Child had a slight fever for roughly 24 hours, and was given motrin on 06.20.2025 and 06.21.2025.  They went to their primary care physician determining it an adverse reaction.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: There were two sets of Pentacel, Prenvar20, and Rota ordered.  Two staff members were preparing vaccines next to one another.  Nurse looked over at second staff member and saw her inject the Prevnar20 into the Pentacel vial. Nurse  immediately stopped what she was doing and alerted staff member of what she witnessed. Nurse took those vaccines from staff member and set them aside not to use.  Nurse then retrieved a new Pentacel set and Prevnar20, and prepared and administered the correctly mixed vaccines.  The VFC program was notified of the wasted Pentacel and Prevnar20.  The staff member was placed on a safety pause while she receives re-education on the vaccines and the immunization workflow.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administration error.  Vaccine expired on 6/22/25 and given on 6/24/25
Age: 85.0
Sex: M
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Ongoing right localized arm pain 4 months post vaccine.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: 06/20/25- Rash all over  the body developed same day vaccine was given, hours later. Mother said it looked like hives, patient was very fussy and scratching. Mother gave benadryl and rash completely resolved within 2 hours of the medication. Mother gave benadryl the next morning to prevent rash from returning, but it did not return. The next day on 06/21/25 she had a red bump and swelling at the injection site. 06/24/25- Redness has resolved and just has a hard tender lump in the area.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Irritability, Pruritus, Rash, Urticaria
Clinical narrative: 06/20/25- Rash all over  the body developed same day vaccine was given, hours later. Mother said it looked like hives, patient was very fussy and scratching. Mother gave benadryl and rash completely resolved within 2 hours of the medication. Mother gave benadryl the next morning to prevent rash from returning, but it did not return. The next day on 06/21/25 she had a red bump and swelling at the injection site. 06/24/25- Redness has resolved and just has a hard tender lump in the area.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Paraesthesia, Vomiting
Clinical narrative: Headache, lightheadedness, vomiting, tingling in extremities-patient parent took patient to ED for further evaluation, patient was treated and released home
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: When I went to give the patient her meningococcal injection notice only had 0.25 ml. Pulled up another injection only had 0.25 ml Ask Provider to come look to confirm. Call RN  to advise on what to do. Was told to call someone else. Was told to give the other 0.25 to equal 0.5 ml
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Aphasia, Blindness, Neurological symptom
Clinical narrative: Roughly 1/2 hr after receiving the flu vaccine, he endorsed stroke like symptoms that he couldn't understand/comprehend people talking, couldn't see, and couldn't talk. He went to sleep it off and when he woke up many hours later, his symptoms resolved. This occurred while he was deployed to (redacted) in Dec 2024.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine to patient. Expired May 21st 2025. Administered 6/23/25
Age: 51.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: No adverse event, Underdose
Clinical narrative: Gave children's dose to an adult. No other adverse reactions noted.
Age: 43.0
Sex: M
Vaccine: TYP, YF
Symptoms: Disorientation, Dizziness, Hyperhidrosis, Mydriasis, Unresponsive to stimuli
Clinical narrative: Patient was instructed to wait in the pharmacy waiting area for RPH to monitor as that is protocol with YF-VAX. After a few minutes the patient called out to RPH and said he felt faint. RPH went out to his side and patient then became disoriented in his chair, could not respond to RPH calling his name and pupils were dilated. RPH instructed lead tech to call 911. Patient became responsive again and did not want 911 to come by. RPH got patient an ice pack a water and an orange juice. Patient started to faint again and was sweating. EMS checked his vitals and he was cleared to be taken home with his partner that came into the store. Patient was alert and oriented when he left.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Continued shoulder and arm pain.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Face oedema, Lip oedema
Clinical narrative: Patient reports that 4 days after initial shot started to develop facial edema starting in lips and progressing to cheeks. lasted for about 36 to 48 hours. Patient applied ice packs and self administered ibuprofen and diphenhydramine from over the counter. No further progression or adverse effects.  No lasting effects .
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Inbound call from pharmacist calling to inquire about GARDASIL-9 dosing schedule.  Caller states that patient received her first dose of GARDASIL-9 a year prior on 13-JUN-2024 and received her second dose in 02-JUN-2025.  Pharmacist states that patie; This spontaneous report was received from a pharmacist and refers to a 45-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided.  On 13-JUN-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis.  On 02-JUN-2025, she was administered the second dose of Human Papillomavirus 9-valent Vaccine (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis (Inappropriate schedule of product administration). No adverse events were reported.  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC; Patient was given their first dose of CAPVAXIVE in February 2025 and a second dose of CAPVAXIVE on 04JUN2025; This spontaneous report was received from an office manager who placed a physician on the line, and refers to a 75-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unspecified date in February 2025, the adult patient was administered the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis. On 04-Jun-2025, the adult patient was administered the second dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site, lot # and expiration date were not reported) for prophylaxis (extra dose administered). No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event). No additional information was reported.  Lot # is being requested and will be submitted if received.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Inbound call from HCP to report AE for VAQTA. HCP noted that a dose of expired VAQTA was inadvertently administered to a patient. No symptomatic events were reported. Information regarding supported dose of VAQTA was provided via post-memo article. N; This spontaneous report was received from a Pharmacist 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 06-Jun-2025, the patient started therapy with Hepatitis A Vaccine, Inactivated Injection(VAQTA) (lot #X026485, expiration date: 11-May-2025)(a dose of expired VAQTA was inadvertently administered to a patient). No symptomatic events were reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE; HCP calling to report an AE regarding the VARIVAX vaccine. HCP reported that a one year old male patient received a smaller than recommended dose of the VARIVAX vaccine. HCP stated that the patient did not receive the full dose of the vaccine and hal; This spontaneous report was received from a medical assistant and refers to a 1-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.   On 23-JUN-2025, the patient was vaccinated with varicella virus vaccine live (Oka-Merck) (VARIVAX) solution for injection (exact dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) before administration (lot # and expiry date were not provided). The patient did not receive the full dose of the vaccine, and half the dose was given to him inadvertently (Accidental underdose). No additional adverse event (AE) was reported.   Lot # is being requested and will be provided if received.
Sex: F
Vaccine: RSV
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: Rash became cellulitis/Cellulitis near Arexvy injection site; This non-serious case was reported by a consumer and described the occurrence of injection site cellulitis in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included asthma. Concurrent medical conditions included egg allergy (egg white and egg yolk allergy), grass allergy, spice allergy, allergy to plants (Mold and Ragweed) and drug allergy (Allergic to ampicillin, erythromycin, Avelox, Lincocin, Seconal, atropine, fillers used in Doxycycline tablets, NSAIDS).   On 07-JUN-2025, the patient received Arexvy (right deltoid). On 08-JUN-2025, 1 days after receiving Arexvy, the patient experienced injection site cellulitis (Verbatim: Rash became cellulitis/Cellulitis near Arexvy injection site). The patient was treated with doxycycline (Doxycycline Monohydrate). The outcome of the injection site cellulitis was not resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Arexvy.     It was unknown if the company considered the injection site cellulitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-JUN-2025 This report was submitted via the online direct entry reporting system. The patient had vaccine, and rash became cellulitis and cellulitis occurred near Arexvy injection site.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I too have Shingles too it's really bad on my back  I have on legs arms too; Received 3rd dose of vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included stress. Family history included alzheimer's disease (husband who has Alzheimer's.).   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I too have Shingles too it's really bad on my back  I have on legs arms too) and extra dose administered (Verbatim: Received 3rd dose of vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2025 This case was reported by a patient via interactive digital media. The patient got the 3 shots and after that have Shingles too it was really bad on the back, on legs and arms too. The patient was on different types of medicines too they told have a lot of stress in the life and that's what activated them. The patient had it over a year now.  The stress was from taking care of husband who has Alzheimer's. 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 (Dose 1, 2 & 3)
Vaccine: VARZOS
Symptoms: Dyspnoea, Electric shock sensation, Pain, Performance status decreased
Clinical narrative: Pain; electric shocks; could not sleep; could not breathe; could not function; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: Pain), electric shock (Verbatim: electric shocks), insomnia (Verbatim: could not sleep), difficulty breathing (Verbatim: could not breathe) and performance status decreased (Verbatim: could not function). The outcome of the pain, electric shock, insomnia, difficulty breathing and performance status decreased were not reported.   It was unknown if the reporter considered the pain, electric shock, insomnia, difficulty breathing and performance status decreased to be related to Herpes Zoster vaccine.     It was unknown if the company considered the pain, electric shock, insomnia, difficulty breathing and performance status decreased to be related to Herpes Zoster vaccine.   Additional Information: GSK Receipt Date:14-JUN-2025 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient could not, the pain was unreal and could not breathe, sleep or function. The reporter stated that it was sheer torture, stabbing, electric shocks, etc.
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: be sick for 8 months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: be sick for 8 months). The outcome of the sickness was resolved (duration 8 months).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUN-2025 This case was reported by a patient via interactive digital media. The patient stated others can take the vaccine shots (2 Shingrix) and be sick for 8 months, like he/she was after the vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; but she still had it; 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: but she still had it). 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: 15-JUN-2025  This case was reported by a patient via interactive digital media. The reporter just had it too even though having vaccines, but taking antibiotics right away, it was not bad but yes it was so painful. This case was considered as suspected vaccination failure as details regarding primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case US2025AMR078645 reported by the same reporter; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR078645:Same reporter/ diff patient
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: not as painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: not as painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-JUN-2025 This case was reported by a patient via interactive digital media. Patient stated had 2 round of medicine 14 days starting to look better and I had the 2 shots few years back but didn't feel to bad shot make it not as painful still no you have them.
Vaccine: VARZOS, VARZOS
Symptoms: Frustration tolerance decreased, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles on his/her face; 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 facial herpes zoster (Verbatim: shingles on his/her face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving.   It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2025 This case was reported by a patient via interactive digital media. Patient had received both shots and was recovering from shingles on his/her face.  It had been very frustrating and annoying trying to deal with them.  It was everything they said it would be. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose) and Shingles (2nd dose) .
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; Incomplete course of vaccination; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In DEC-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the shingles was not resolved and the outcome of the incomplete course of vaccination was not applicable.   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: 16-JUN-2025 This case was reported by a patient via interactive digital media. The patient received the first shot 6 months ago and had shingles now. Till the time of reporting the patient did not receive the second dose of Shingles vaccine which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; but she still had it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: but she still had it). 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: 15-JUN-2025  This case was reported by a patient via interactive digital media. The reporter reported that reporter sister had shots, but she still had it, terrible pain for months. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with US2025AMR077327 reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR077327:Same reporter/ diff patient
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received 4th dose; Second dose: Jan 29 2025 Third dose: Feb 26 2025; First Dose: Sept 03 2024 Second dose: Jan 29 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 03-SEP-2024).   On 29-MAY-2025, the patient received the 4th dose of Engerix B. On 26-FEB-2025, the patient received the 3rd dose of Engerix B. On 29-JAN-2025, the patient received the 2nd dose of Engerix B. On 29-JAN-2025, not applicable after receiving Engerix B and Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: First Dose: Sept 03 2024 Second dose: Jan 29 2025). On 26-FEB-2025, the patient experienced drug dose administration interval too short (Verbatim: Second dose: Jan 29 2025 Third dose: Feb 26 2025). On 29-MAY-2025, the patient experienced extra dose administered (Verbatim: Patient received 4th dose). The outcome of the extra dose administered, drug dose administration interval too short and drug dose administration interval too long were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-JUN-2025 A registered nurse reported that the patient received their first dose of Engerix B on 3rd September 2024, their second dose on 29th January 2025, the third dose on 25th February 2025 and the fourth dose on 29th May 2025. The nurse initially stated they wanted data about the administration of a vaccine because the intervals were shorter than recommended. They also stated the need to test for titers. The Vaccine Administration Facility was the same as Primary Reporter The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B earlier than recommended interval, which led to shortening of vaccination schedule.  The patient received 4th dose of Engerix B not as per local schedule, which led to extra dose administered.; Sender's Comments:  US-GSK-US2025071733:same reporter
Age: 37.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Engerix-B late third dose; Engerix-B late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 37-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 03-NOV-2014).   On an unknown date, the patient received the 3rd dose of Engerix B. On 20-JUL-2015, the patient received the 2nd dose of Engerix B. On 20-JUL-2015, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Engerix-B late second dose). On an unknown date, the patient experienced drug dose administration interval too long (Verbatim: Engerix-B late third dose). The outcome of the drug dose administration interval too long and drug dose administration interval too long were not applicable.   Additional Information: GSK Receipt Date: 13-JUN-2025  The pharmacist reported that an adult female patient had received a first Engerix-B dose on 03rd November 2014 and a second Engerix-B on 20th July 2015 and received 3rd dose late. No data about lot number or expiration dates. The vaccine administration facility was the same as primary reporter. The patient received 2nd and 3rd dose later than official recommendation which led to lengthening of vaccination schedule.
Age: 20.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix less than 30 days expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9532Y, expiry date 23-MAY-2025) for prophylaxis.   On 16-JUN-2025, the patient received the 4th dose of Boostrix. On 16-JUN-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix less than 30 days expired dose administration). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-JUN-2025 A nurse manager wanted to know how to proceed after giving an expired dose of Boostrix (05.23.25) on 16th Jun 2025 (less than 30 days between both dates) which led to expired vaccine use. It was the fourth dose in the immunization schedule and the second o Boostrix that the patient received
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: Lymphedema; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (Lymphedema) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (Lymphedema). At the time of the report, LYMPHOEDEMA (Lymphedema) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No Concomitant medication was reported. She added that similar symptoms happened around 3 years ago, after Moderna vaccine, she started manual lymphatic drainage, for lymphedema after first episode. She contacted GP 3rd week in May for pain relief, and started manual lymphatic drainage again as was successful after 18 months. It was unknown if the patient experienced any additional symptoms/events. No treatment drug was reported.   This case was linked to MOD-2025-787680 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immune system disorder, Interchange of vaccine products, Post-acute COVID-19 syndrome
Clinical narrative: long COVID; developed "auto-immune" problems; developed COVID19; developed COVID19; interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccines (Primary immunization series completed), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) both with onset Nov2022, outcome "unknown", described as "developed COVID19"; POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown", described as "long COVID"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "developed "auto-immune" problems".  Clinical course: Reporter states received a Pfizer mRNA shot in Oct2022 (after receiving the Moderna vaccines for her primary series). She states that she developed COVID19 in Nov2022. Since that time, she stated she has developed  autoimmune problems and wonders if she has "long COVID". It was unknown if patient received any other vaccines on the same date as the vaccine and 4 weeks prior to the vaccine. It was also unknown if the patient was taking any other medication 2 weeks prior to the event starting  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Dysstasia, Gait disturbance
Clinical narrative: the patient began experiencing difficulty walking; they could no longer stand or walk; stroke; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 2, single (Lot number: ER2613) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 23Feb2021, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Nov2021, outcome "recovered", described as "stroke"; GAIT DISTURBANCE (non-serious), outcome "recovered", described as "the patient began experiencing difficulty walking"; DYSSTASIA (non-serious), outcome "recovered", described as "they could no longer stand or walk". Therapeutic measures were taken as a result of cerebrovascular accident, gait disturbance, dysstasia.  Clinical course: Patient experienced a stroke in Nov2021 (Stated afterwards that she doesn't recall the date, but was before getting the Pfizer Covid 19 Shot). After 8 weeks of therapy, made a full recovery, regaining the ability to walk, go up and down stairs, and showing no remaining reactions, whatsoever. Prior to the stroke, the patient received the first dose of the Pfizer COVID-19 vaccine in Feb2021, with no adverse reaction. Approximately a month later (Mar2021), received the second dose. Within a few days of the second shot, the patient began experiencing difficulty walking, which progressed to the point where they could no longer stand or walk. Patient would like to know if those side effects are common or rarely common after the Covid 19 shot.  No follow-up attempts are possible.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: did have the COVID/I got two vaccines from Pfizer; did have the COVID/I got two vaccines from Pfizer; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 74-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did have the COVID/I got two vaccines from Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: "I was just calling, I have a patient on my back line who express that he was taken the Paxlovid in 2020 when he did have the COVID. So, I was just transferring him over to you all to let him express his experience on the medication." When paraphrased the above concern, transferring agent stated, "Yes, that is correct 2020." When paraphrased the above concern, consumer confirmed the same. Consumer stated, "I got to go to the drugstore. I am very sick." When probed if consumer has taken the Paxlovid medication before, consumer stated, "I took in 2020 and I also got my shots from you. I got two vaccines from Pfizer." Consumer stated, "I just got to go to drugstore and get my medicine." During an inbound call for financial assistance, the patient stated, "I have COVID, and I'm sick, and they called in my prescription last time I think I spent 10 or 15 Dollar". After confirming the reason for the call, the patient stated, "I took it like in 2020. I got COVID back then" Then the patient stated, "I also got your shots, I also got the two Pfizer shots just so you know." After providing enrollment options, the patient stated, "I'm not feeling well at all"   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.