chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: No adverse event
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: I accidentally gave the patient the Moderna vaccine shortly after the DOh discontinued it. The vaccine was not expired.
Age: 19.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Tachycardia
Clinical narrative: severe headache, tachycardia to 130 bpm, chills within 12 hours of vaccination
Age: 1.17
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: unknown effect- no adverse event reported by parent
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: MMR was given with expired expiration date. Vaccine given on 1/09/2025 and expiration date was 01/02/2025.  no adverse outcome related to event. State immunization specialist contacted for advice- vaccine will still provide protection. Did not recommend redosing unless parent requested. Parent and physician notified.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Two flu shots given in same season, 10/2024 and 1/2025. No adverse reactions.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Donor reported erythema and tenderness at injection site starting approximately 8 hours post injection. Donor reported that she treated herself with ibuprofen, acetaminophen, and warm/cold compresses to site.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse events reported by patient at this time.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder injury, Chest X-ray, Computerised tomogram abdomen, Culture urine, Cystoscopy abnormal
Clinical narrative: Gross hematuria with egg sized clots. Went to the ER. Was there for 12 hours. Many diagnostics done . Sent home on antibiotics.  Hematuria returned on 10-17-24. Called Dr.'s answering service. Was told to go back to the ER.  Many tests  done. Sent home again on antibiotics. Dr. did an in office cystoscope on 10/22/24. Nothing found except many small abrasions on the walls of my entire bladder.  He suggested it was a post vaccine adverse reaction but gave me no further plan of care. I doubt he reported it.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Haematuria, Laboratory test, Thrombosis
Clinical narrative: Gross hematuria with egg sized clots. Went to the ER. Was there for 12 hours. Many diagnostics done . Sent home on antibiotics.  Hematuria returned on 10-17-24. Called Dr.'s answering service. Was told to go back to the ER.  Many tests  done. Sent home again on antibiotics. Dr. did an in office cystoscope on 10/22/24. Nothing found except many small abrasions on the walls of my entire bladder.  He suggested it was a post vaccine adverse reaction but gave me no further plan of care. I doubt he reported it.
Age: 28.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: The patient was in today to get the Menquadfi vaccine but was given the Prevnar 20 vaccine instead by the pharmacy technician
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient complained of dizziness and nausea two days after receiving vaccine
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Brain fog, Injection site discolouration, Injection site pain, Injection site pruritus, Product administered at inappropriate site
Clinical narrative: Received varicella #2 on 12/9/24 at Pharmacy. The injection was administered to back of left arm near triceps area, subcutaneous. Alcohol was rubbed on for a while before administering. The next day, noticed very bright raised patch to injection site area. The area was itching intermittently for a few days and was painful to the touch. Felt brain fog for a day or two. Had scratchy throat on 12/12, but no other symptoms. Family has pictures documenting rash - when she was seen in the office on 12/13/24, it was minor discoloration to skin in area where bright erythematous rash previously was.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Throat irritation
Clinical narrative: Received varicella #2 on 12/9/24 at Pharmacy. The injection was administered to back of left arm near triceps area, subcutaneous. Alcohol was rubbed on for a while before administering. The next day, noticed very bright raised patch to injection site area. The area was itching intermittently for a few days and was painful to the touch. Felt brain fog for a day or two. Had scratchy throat on 12/12, but no other symptoms. Family has pictures documenting rash - when she was seen in the office on 12/13/24, it was minor discoloration to skin in area where bright erythematous rash previously was.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: Medical Assiten reported On Wednesday January 8, 2025, patient DOB: 06/XX/2022 Acct# XXX came in to the office for a WCC. Patient was due for a total of 8 vaccines. Mop did not want to have child be poked more than 3 times so I tried to find a way to do some combo vaccines. To avoid less injections. I had spoke with our IZ coordinator to figure out if any of the vaccines listed for patient could be combined and we had agreed on giving pt Pentacel, Hep A,  ??and MMRV. Unfortunately I must have been distracted and grabbed an extra vaccine (Vaxelis) which already includes Dtap, IPV, & HIB same as the Pentacel dose. Causing me to give patient double of those doses. I have called MOP and left her a voicemail advising her to call the office back to notify of situation. I also advised Dr. of the situation.
Sex: M
Vaccine: DTAPIPVHIB, DTPPVHBHPB, DTAPIPVHIB, DTPPVHBHPB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Medical Assiten reported On Wednesday January 8, 2025, patient DOB: 06/XX/2022 Acct# XXX came in to the office for a WCC. Patient was due for a total of 8 vaccines. Mop did not want to have child be poked more than 3 times so I tried to find a way to do some combo vaccines. To avoid less injections. I had spoke with our IZ coordinator to figure out if any of the vaccines listed for patient could be combined and we had agreed on giving pt Pentacel, Hep A,  ??and MMRV. Unfortunately I must have been distracted and grabbed an extra vaccine (Vaxelis) which already includes Dtap, IPV, & HIB same as the Pentacel dose. Causing me to give patient double of those doses. I have called MOP and left her a voicemail advising her to call the office back to notify of situation. I also advised Dr. of the situation.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dr ordered HPV vaccine to be given and a Meningococcal Group B vaccine was given instead. No known adverse reaction.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: Patient was given Vaccine at HD on 12/6/2025 Vaccine did not appear on State System Printed for Visit on 12/10/24 Per Providers order Vaccine was Given on 12/10/24
Age: 1.83
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: About 15 minutes following  his vaccination, he had small raised bumps on his left foot. He was observed for 45 minutes after the reaction and spots were resolving. There were no additional symptoms or rashes at the time. After leaving clinic, through the night he continued to have intermittent breakouts over his entire body which were itchy. No difficulties breathing or GI symptoms.
Age: 78.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine given in error. He should have been given Hep B Adult. Was instead given Hep B pediatric. NO ADVERSE REACTION. Pt reports no reaction, swelling, pain or redness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Sight swelling and erythema, recommended zyrtec and keflex
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient had vaccine done at her child's pediatrician's office. Suffered shoulder injury related to vaccine administration. Has had ongoing pain with movement in left shoulder for 3 weeks. Pain with overhead reaching. Mildly improving over time.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event reported- patient received 3 doses of shingrix which is 1 more than the recoemmended
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient came in for Covid-19 shot.  The time would be 11/26/2024.  Patient stated that the left arm started aching around December 3, 2024.   Patient was encouraged to see the doctor.  Doctor prescribed an antibiotic and Prednisone.   Patient still having pain in left arm and said that she was having an x ray on 01/20/2025.    Patient did receive a Flu shot at Clinic on or around12/12/2024 after receiving the covid shot  but it was in the right arm. According to patient
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient came by pharmacy on 01/15/25 to report adverse event related to the vaccination. The patient described a painful site after injection of the arm with bruising and next day after receiving the shot had to go to Urgent Care for further treatment. Patient was then referred to hospital from urgent care and had an unknown length of stay (patient did not report). Currently patient is still experiencing a large amount of pain for the last three months and is still receiving further treatment
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Pruritus
Clinical narrative: Minor's grandmother reported  reaction to health dept almost 24 hrs after vaccine administration by phone. Minor's grandmother reports 15 minutes after minor received vaccine reaction occurred while traveling in car. Pt. became pale , sweaty, dizzy,  and nauseated. He was splotchy red from head to toe and itching. No breathing problems noted. Pt. did not lose consciousness. Benedryl 25mg was administered by guardian about 30 minutes after vaccine given. Symptoms began to resolve at that time but pt still felt faint and itchy after 2 hours so another benedryl 25mg tab was administered. Symptoms resolved shortly after.  At this time, 22 hrs later, pt has not had another episode.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Rash macular
Clinical narrative: Minor's grandmother reported  reaction to health dept almost 24 hrs after vaccine administration by phone. Minor's grandmother reports 15 minutes after minor received vaccine reaction occurred while traveling in car. Pt. became pale , sweaty, dizzy,  and nauseated. He was splotchy red from head to toe and itching. No breathing problems noted. Pt. did not lose consciousness. Benedryl 25mg was administered by guardian about 30 minutes after vaccine given. Symptoms began to resolve at that time but pt still felt faint and itchy after 2 hours so another benedryl 25mg tab was administered. Symptoms resolved shortly after.  At this time, 22 hrs later, pt has not had another episode.
Age: 44.0
Sex: M
Vaccine: COVID19, FLU3, TDAP
Symptoms: Dizziness, Hypotension
Clinical narrative: Patient presented to Employee Health office for pre-employment health screening. After administration of Flu, Covid, and Tdap vaccine caregiver began experiencing lightheadedness and hypotension. No syncopal episode occurred. Caregiver reports hx of lightheadedness following blood draw, but states he normally recovers quickly. Caregiver was monitored for 20 minutes but hypotension and lightheadedness failed to resolve. Rapid response was called over facility intercom and rapid response nurse evaluated patient and transported patient to emergency department for evaluation. Caregiver denies any previous reaction to vaccines. Vitals as follows: 1135 am BP 83/43, 1140 am BP 69/39 HR 37, 1145 am BP 68/43 HR 45, 1150 am BP 74/44 HR 47.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered the incorrect vaccine for the patient's age. Administered Covid 19 Moderna vaccine for ages 6 -11 years (0.25ml, IM).
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 YEAR OLD presented to office with redness and swelling around in injection site of Quadracel. Given in right thigh. 7X5 cm.  No wheezing, GI symptoms joint swelling or rash elsewhere.  Suspected mild/ moderate local reaction to vaccine related to immune response. No concern for serum sickness.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered the wrong Covid vaccine for the patient's age. Administered Moderna Covid 19 for ages 6-11 years.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Loss of personal independence in daily activities, Pain, Pain in extremity, Rash
Clinical narrative: 4 year old received MMRV and Dtap-IPV on 12/2/24. In the days after had pain. It seemed to be better for a week or so. Family reports that around Christmas he was noted to have a rash the mother thought was hive-like. Around that time he started to report leg pain and not wanting to do things. Pain seems to be less now but still will unprompted report pain. He has not played at school for the last three days due to leg pain.
Age: 24.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: nothing
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site Red, Swollen, Raised, Warm to touch.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had received dose previously on 10/5/2023. Second dose was not advised per current CDC/ACIP guidelines.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had received dose previously on 10/5/2023. Second dose was not advised per current CDC/ACIP guidelines.
Age: 42.0
Sex: F
Vaccine: HEP, PNC21
Symptoms: Abscess, Erythema, Peripheral swelling
Clinical narrative: pateint called on 01/15/2025 morning and reported that her right arm is swallon and red. later in day she had dr appoitment and dr said its looks like abses. pateint prescribed antibiotics.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: On 1/6/2025 pt was to receive Pentacel vaccine (DTAP/IPV/HIB). The Medical Assistant administering did not administer the HIB vial as part of the vaccine. Before administering the DTAP/IPV part of the vaccine they mixed it with Sterile Water Diluent and administered the vaccine. Contacted manufacturer the vaccine is subpotent due to being administered with Sterile Water Diluent.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Vaccine exposure during pregnancy; No symptoms reported; This spontaneous report was received from Other Health Professional and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-JAN-2025, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #Y014510, expiration date: 01-NOV-2026, administered for prophylaxis (strength, and route of administration were not provided).  The patient was pregnant when vaccination (Vaccine exposure during pregnancy), no symptoms reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; patient received GARDASIL 9 dose outside of the Prescribing Information schedule regimen/received first dose on July 2012, second dose September 2013 and has not yet received third dose; This spontaneous report was received from a nurse practitioner concerning to a patient of unspecified age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On an unknown date in July 2012, the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (lot #, expiry date, anatomical location and route of administration were not provided). Then, on an unknown date in September 2013, the patient was vaccinated with the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (lot #, expiry date, anatomical location and route of administration were not provided) (inappropriate schedule of product administration). Both vaccine doses were administered as prophylaxis. The patient had not received vaccine 3rd dose yet.  No additional adverse event (AE) was reported (no adverse event.)  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: VARCEL
Symptoms: Skin laceration, Syringe issue
Clinical narrative: Injury to hand NOS; noticed that 2 of the vials were broken and multiple shreds of glass were in the tray; This spontaneous report as received from Medical Assistant referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 09-JAN-2025, around 4:00pm, a shipment of varicella virus vaccine live (oka/merck)(VARIVAX) lot # Y014868, expiration date: 03-SEP-2026 (strength, dose, dose number, route, and anatomical location were not provided) for prophylaxis arrived and when opening the carton, the customer noticed that 2 of the vials were broken and multiple shreds of glass were in the tray (Syringe issue); the body of the vial was broken; the neck and where the cap is was not affected    There was lyophilized powder in the tray and some remained in the bottom of the vials. It was reported that there was a call to vaccine shop and they told her to discard the product so the product had been discarded and could not be returned and pictures cannot be provided; when cleaning up the shards of glass, the customer hand was cut a little bit. She reports that it was "no big deal" (Limb injury); The patient stated that it was cut on the hand by the shreds of glass when removing them from the tray    The outcome of limb injury was unknown.     The action taken with varicella virus vaccine live (oka/merck)(VARIVAX) wa snot reported.  The causal relationship between limb injury and therapy with varicella virus vaccine live (oka/merck)(VARIVAX) was not provided.
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: (Meningococcal B (Bexserol incorrectly administered to an adolescent intended to receive Meningococcal ACWY MenQuadfi; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of wrong vaccine administered in a adolescent patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero and did not receive Menquadfi. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: (Meningococcal B (Bexserol incorrectly administered to an adolescent intended to receive Meningococcal ACWY MenQuadfi ). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that the patient received Meningococcal vaccine B (Bexsero) incorrectly who was intended to receive meningococcal ACYW 135 (T CONJ) vaccine (Menquadfi) with no reported adverse event, which led to wrong vaccine administered.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles/got it again; 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.   The patient's past medical history included shingles (4 times on face) and pain.   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: shingles/got it again). 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-DEC-2024 This case was reported by a patient via interactive digital media. The patient got vaccinated with Shingles vaccine because he/she got shingles 4 times on face, but a few months ago in 2024 (from the date of reporting) with everything plus Shingles vaccination he/she got it again, the only thing was that the pain was not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: there were times that he could not sit; experienced extreme arm soreness of the injected arm ever since receiving the vaccine; after receiving Shingrix vaccine this sensation in his buttocks went away; This non-serious case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pain in arm. Previously administered products included Covid-19 vaccine (had received Covid-19 vaccine in the past). Concurrent medical conditions included feeling abnormal (before receiving Shingrix, he was having a sensation in his buttocks as if shingles was coming on) and mobility decreased (many times that he could not sit).   In SEP-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injected limb mobility decreased (Verbatim: there were times that he could not sit), pain in arm (Verbatim: experienced extreme arm soreness of the injected arm ever since receiving the vaccine) and unexpected therapeutic effect (Verbatim: after receiving Shingrix vaccine this sensation in his buttocks went away). The outcome of the injected limb mobility decreased was not reported and the outcome of the pain in arm was not resolved and the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.     It was unknown if the company considered the injected limb mobility decreased and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 16-DEC-2024 The reporter self-reported this case for him. He received the first dose of Shingrix vaccine in first week of September 2024 in the upper left arm, close to the shoulder. The reporter was experiencing extreme soreness of the injected arm ever since receiving the vaccine and felt as if he was punched in the shoulder 3 to 4 times. The reporter stated that he did had mobility of the left arm, but when he uses it, it gets aggravated and becomes more sore. The patient stated that before receiving Shingrix, he was having a sensation in his buttocks as if shingles was coming on and there were times that he could not sit. The reporter reported that after receiving Shingrix, this sensation in his buttocks went away, which led to unexpected therapeutic effect. The patient stated he had received other vaccines in the past (such as COVID), but had not experienced long term soreness in the arm as he was with Shingrix. He reported that he had an appointment to see his doctor on the day of reporting.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Laboratory test, Pain in extremity, Urticaria
Clinical narrative: burning in her arm; arm hurt/ pain in her arm; hives all over body; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-SEP-2024, the patient received the 1st dose of Shingrix (left arm). On 07-SEP-2024, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm hurt/ pain in her arm). In SEP-2024, the patient experienced generalized urticaria (Verbatim: hives all over body). On an unknown date, the patient experienced burning sensation (Verbatim: burning in her arm). The patient was treated with loratadine (Claritin). The outcome of the generalized urticaria was not resolved and the outcome of the pain in arm and burning sensation were unknown.   It was unknown if the reporter considered the generalized urticaria, pain in arm and burning sensation to be related to Shingrix.     It was unknown if the company considered the generalized urticaria, pain in arm and burning sensation to be related to Shingrix.   Additional Information: GSK Receipt Date 16-DEC-2024 The patient self-reported this case for herself.  She stated that she was vaccinated with her first dose of Shingrix and a few days after vaccination with Shingrix she had hives all over her body.  She was examined by her PCP (primary care physician) and given a prescription for short term steroid use and Claritin to be used for 30 days in 2024. The reporter instructed if hives did not resolve to make an appointment with an allergist. The patient stated she was exam and tested by an allergist who stated she did not show allergies to anything.  The patient mentioned it had been 3 months since vaccination with Shingrix and she still currently has hives all over her body. She stated that her arm hurt immediately upon vaccination with Shingrix. She experienced burning and pain in her arm after the injection in 2024. The reporter did not provide lot number for Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex reactivation, Incomplete course of vaccination
Clinical narrative: reactivation of Herpes Simplex/five days after the 1st  vaccination she had an outbreak with herpes simplex; This non-serious case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex (she was diagnosed with herpes simplex in the early 1970's and she stated that herpes outbreaks stopped in the mid 1970's).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced herpes simplex (Verbatim: reactivation of Herpes Simplex/five days after the 1st  vaccination she had an outbreak with herpes simplex). The outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.     It was unknown if the company considered the herpes simplex to be related to Shingrix.   Additional Information: GSK receipt date: 16-DEC-2024 The patient was the reporter.  The reporter reported that last forty years she had not had any outbreaks and was not on any medication used as a prevention for outbreaks. The patient stated that she was vaccinated with dose one of Shingrix in early 2023 and five days after the vaccination she had an outbreak with herpes simplex. The patient mentioned that she had one blister and that has resolved, and she had not had anymore outbreaks since her vaccination.  The reporter reported that due to this reactivation of Herpes Simplex she had not had the second dose administered (missed dose).
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia
Clinical narrative: Vertical Double Vision; This non-serious case was reported by a consumer via call center representative and described the occurrence of double vision in a 71-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis.   On 06-DEC-2024, the patient received Fluarix 2024-2025 season. On 07-DEC-2024, 1 days after receiving Fluarix 2024-2025 season, the patient experienced double vision (Verbatim: Vertical Double Vision). The outcome of the double vision was resolving.   It was unknown if the reporter considered the double vision to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     It was unknown if the company considered the double vision to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-DEC-2024 The case was self reported by patient.  The patient received Fluarix vaccine and the following day, the patient began experiencing vertical double vision which lasted all week.   The vertical double vision was better yesterday and today. This case is linked with US2024159689, reported by same reporter.; Sender's Comments:  US-GSK-US2024159689:Same reporter/Different patient
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 4 month old patient was inadvertently administered with a first dose of FLULAVAL; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number FJ47R, expiry date 07-JUN-2025) for prophylaxis.   On 22-NOV-2024, the patient received the 1st dose of FluLaval 2024-2025 season. On 22-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: a 4 month old patient was inadvertently administered with a first dose of FLULAVAL). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-DEC-2024 The registered nurse reported that a patient of an inappropriate age was inadvertently administered with a first dose of Flu Laval vaccine, which led to inappropriate age at vaccine administration.  The reporter wanted to knew if that can be considered a valid dose, or which advise or guidance can they provide them. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: overdose; 18 year old patient received an adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B adult) (batch number 5JX2E, expiry date 14-DEC-2026) for prophylaxis.   On 03-DEC-2024, the patient received the 1st dose of Engerix B adult. On 03-DEC-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: overdose) and adult product administered to child (Verbatim: 18 year old patient received an adult dose). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-DEC-2024 The 18 year old patient received an adult dose of Engerix B, which led to overdose and adult product administered to child. This is 1 of 5 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024013448:SAME REPORTER US-GSK-US2024055489:SAME REPORTER US-GSK-US2024055491:SAME REPORTER US-GSK-US2024061882:SAME REPORTER
Sex: F
Vaccine: HEP
Symptoms: Antibody test abnormal, Therapeutic response decreased
Clinical narrative: Low Hepatitis B titers; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a 18-year-old female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced therapeutic response decreased (Verbatim: Low Hepatitis B titers). The outcome of the therapeutic response decreased was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-DEC-2024 Reporter stated they had an 18-year-old patient who had low titers on her Hepatitis B and needed an Engerix-B booster. Therefore, there was no additional information available.  The patient's previous Hepatitis B vaccination history was not known.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of Rotarix first dose over age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 5n2an, expiry date 10-MAY-2026) for prophylaxis.   On 22-OCT-2024, the patient received the 1st dose of Rotarix lyophilized formulation. On 22-OCT-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Rotarix first dose over age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-DEC-2024 The patient's age was 17 weeks and 4 days old The nurse reported that the patient of inappropriate age received first dose of Rotarix vaccine, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric dose to adult patient; Engerix-B pediatric dose to adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 42-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis.   On 25-NOV-2024, the patient received Engerix B pediatric. On 25-NOV-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose to adult patient) and underdose (Verbatim: Engerix-B pediatric dose to adult patient). The outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-DEC-2024 The pharmacist reported that a pediatric dose of Engerix-B was given to an adult patient, which led to adult use of a child product and underdose. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: 3 patients have received a dose of Priorix expired on December 1st 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a specified number of patients who received MMR (Priorix) (batch number D2LP3, expiry date 01-DEC-2024) for prophylaxis.   On an unknown date, the patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: 3 patients have received a dose of Priorix expired on December 1st 2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-JAN-2025 The clinic administrator reported that at least 3 patients had received an expired dose of Priorix vaccine, which led to expired vaccine used.  The reporter was not sure if the last dose was administered on 21st December and had no patient's data. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given after the maximum recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01-JAN-2022).   On 07-JAN-2025, the patient received the 2nd dose of Shingrix. On 07-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Second dose given after the maximum recommended interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 07-JAN-2025 The pharmacist reported there was administration of 2nd dose of Shingrix after the recommended interval to the patient. The reporter asked Glaxo SmithKline to request data about the administration of Shingrix after the recommended interval. They mentioned this question was asked by someone at their site, so they could not offer data about the patient nor the vaccine. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: The caller further describes the last infection in November as "the worst" as she experienced a "hard time" breathing, when the caller tries to eat it felt like her "throat is closing up like I was getting an allergic reaction to it.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The caller further describes the last infection in November as "the worst" as she experienced a "hard time" breathing, when the caller tries to eat it felt like her "throat is closing up like I was getting an allergic reaction to it.) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included Head injury (5 closed head injuries), Lung scarring (scar tissue forming on lungs) and Gastrointestinal bleeding (bleed internally all the time in my stomach from scleroderma and have to keep on getting iron infusions). Concurrent medical conditions included Chronic kidney disease stage 3 (stage 3 kidney disease), Scleroderma (bleed internally all the time in stomach from scleroderma), Heart disorder (she was in really bad physical shape and the caller's heart was not good either) and Immunocompromised.    On 01-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced COVID-19 (The caller further describes the last infection in November as "the worst" as she experienced a "hard time" breathing, when the caller tries to eat it felt like her "throat is closing up like I was getting an allergic reaction to it.). At the time of the report, COVID-19 (The caller further describes the last infection in November as "the worst" as she experienced a "hard time" breathing, when the caller tries to eat it felt like her "throat is closing up like I was getting an allergic reaction to it.) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient shared that she contracted with COVID-19 despite receiving the said doses. It was reported that patient chest hurts, and heart rate was going up high. The caller was frightened of contracting with COVID-19 the 4th and more time. The caller shared that her provider previously recommended her to get 2 doses of Moderna vaccines by stating one time she was ok for her to have two of them. And they gave her a double dose. She went back a month later and she got another one of the latest vaccine. It was unknown if the patient experienced any additional symptoms and events. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-781009, US-MODERNATX, INC.-MOD-2025-781011, US-MODERNATX, INC.-MOD-2025-781012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781009:Same report for different Product (SPIKEVAX 2024-2025 PFS) US-MODERNATX, INC.-MOD-2025-781011:Same report for different Product US-MODERNATX, INC.-MOD-2025-781012:SPIKEVAX 2024-2025 PFS
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood test
Clinical narrative: Arthritis; Joint pain; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Underactive thyroid" (unspecified if ongoing); "heart failure" (unspecified if ongoing); "cancer" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ARTHRITIS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthritis, arthralgia.  Additional information: Patient wanted to report the adverse reaction to her Covid vaccine (Clarified as Pfizer Covid-19 vaccine). Consumer stated, "Arthritis, Joint pain." Consumer stated, "Yes, however I did not have arthritis until after I took the vaccine. I have never had arthritis or joint pain and I have been taking all these other medications for years." Patient had blood work. It was also reported that the only treatment she have for the event is, she tried Tylenol and Tramadol.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Discomfort, Illness, Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: discomfort; URT; cough; throat pain; sick; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history included: "Periodically eczema/Eczema, left wrist" (unspecified if ongoing), notes: sporadic mostly dormant; "Chigger bite allergy feet irritation" (unspecified if ongoing), notes: Spring  plus summer; "Orthopaedic" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol, notes: (Tylenol occasionally but not at or near time plus date of vaccination (covid)); Relafen, reaction(s): "Drug allergy", notes: do not tolerate NSAIDs plus they generally cause or upper chest rash.; Relafen, reaction(s): "upper chest rash", notes: do not tolerate NSAIDs plus they generally cause or upper chest rash. The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2022, outcome "recovered", described as "URT"; COUGH (non-serious) with onset 2022, outcome "recovered"; ILLNESS (non-serious) with onset 2022, outcome "recovered", described as "sick"; OROPHARYNGEAL PAIN (non-serious) with onset 2022, outcome "recovered", described as "throat pain"; DISCOMFORT (non-serious), outcome "recovered".  Additional information: got sick before holiday with URT cough plus throat pain that took over a month to recover.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400320520 Same patient, different vaccine and event.;
Age: 12.0
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects were reported; ROTATEQ was administered instead of the RSV vaccine BEFORTUS to a 12 day old infant on 09-JAN-2025; This spontaneous report has been received from a Nurse referring a 12-year-old male patient.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 09-JAN-2025, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 milliliter (mL), administered orally (PO) (strength, and indication were not provided; lot # reported as 2032347, which has been determined to be a valid lot # for this vaccine, expiration date provided and validated to be on 22-OCT-2025), this vaccine was administered instead of the Respiratory Syncytial Virus (RSV) vaccine nirsevimab (BEYFORTUS) (also reported as BEFORTUS) to a 12 day old infant (wrong product administered). No adverse effects were reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: flu-like symptoms; felt exhausted; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms) and exhaustion (Verbatim: felt exhausted). The outcome of the influenza-like symptoms and exhaustion were resolved (duration 2 days).   It was unknown if the reporter considered the influenza-like symptoms and exhaustion to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms and exhaustion to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JAN-2025 The patient reported that after her first dose of Shingrix she felt exhausted and flu-like symptoms for 2 days.