chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLUR4
Symptoms: Hyperhidrosis, Injection site pain, Nausea, Sleep disorder, Urinary retention
Clinical narrative: Pt reported significant sweating and nausea/vomiting starting ~1 hr post vaccination.  Reported being unable to keep food down (i.e vomiting around an hour after eating  dinner and breakfast the following morning.)  Pt also reports significant  left medial arm pain adjacent to the injection site. Upon observing the injection site, I can confirm that it wasn't administer in the subacromial bursa.  After pt also reported that he was unable to sleep due to the soreness and inability to urinate I advised pt to seek medical care via the local urgent care center since they were next door, but they recommended that he be seen at that emergency room.
Age: 31.0
Sex: M
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: Pt reported significant sweating and nausea/vomiting starting ~1 hr post vaccination.  Reported being unable to keep food down (i.e vomiting around an hour after eating  dinner and breakfast the following morning.)  Pt also reports significant  left medial arm pain adjacent to the injection site. Upon observing the injection site, I can confirm that it wasn't administer in the subacromial bursa.  After pt also reported that he was unable to sleep due to the soreness and inability to urinate I advised pt to seek medical care via the local urgent care center since they were next door, but they recommended that he be seen at that emergency room.
Age: 13.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction. Inadvertently gave MMRV (second dose of MMR, first dose of varicella documented) to patient who is over age recommendation. Patient is 13 years old and vaccine is recommended until the age of 12.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Came to pharmacy at approximately 5:30pm 2 days after vaccination with child complaining of itching on injection site and unwillingness for any family member to touch arm. Pt had visibly swollen upper left arm . There was some discoloration that was red and splotchy. The swelling discontinued at the elbow and encompassed the shoulder though there was no report of difficulty with movement. The child also did not complain of pain.  There was no report of difficulty swallowing or swelling that extended onto the trunk. Oral Benadryl was recommended as well as a visit to the pediatrician.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash macular, Swelling
Clinical narrative: Came to pharmacy at approximately 5:30pm 2 days after vaccination with child complaining of itching on injection site and unwillingness for any family member to touch arm. Pt had visibly swollen upper left arm . There was some discoloration that was red and splotchy. The swelling discontinued at the elbow and encompassed the shoulder though there was no report of difficulty with movement. The child also did not complain of pain.  There was no report of difficulty swallowing or swelling that extended onto the trunk. Oral Benadryl was recommended as well as a visit to the pediatrician.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Face injury, Fall, Seizure
Clinical narrative: Patient walked back to sitting area to wait his 15 min. Seven (7) minutes past, patient was standing in front of mother and fell face forward on to floor. Patient proceeded to have a seizure for about 2 min. 911 was called and taken to nearby hospital. Vital Signs were taken while waiting for EMS. T: 97.7 axillary, P: 81, R 28, B/P: 120/86, O2: 100%.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Diarrhoea
Clinical narrative: patient described diarrhea over the night, but was self limiting and resolving by morning. Also the page would not let me type in that this is the Fluad Trival 2024-25
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia, Injection site pain, Sleep disorder
Clinical narrative: on 08/09/2024, pt received 2 vaccines ( first dose of shingle  vaccine on the left arm and twinrix on the right arm); pt did not experience any side effect on the day of injection at pharmacy. on 8/24/2024, pt came to pharmacy and reported her left arm has been having pain on the injection site and numbness on the left upper arm. She has been using ice pack on the injection site with no relieve. Pt has been having trouble sleeping on her left arm.  Her right arm has no issue. rec pt to follow up with primary md for an evaluation; pt understood;
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: Back pain, Chest pain, Influenza virus test negative, Injection site erythema, Malaise
Clinical narrative: Redness, induration, warmth at vaccine site and pain radiating to upper back/ thorax, malaise.
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Vaccination site induration, Vaccination site warmth
Clinical narrative: Redness, induration, warmth at vaccine site and pain radiating to upper back/ thorax, malaise.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Flushing, Influenza like illness, Injection site erythema
Clinical narrative: Woke up morning after vaccine feeling nauseous, chills, achy, flushed., flu-like.  Exhausted.  Fell asleep talking on the phone multiple times because I was so wiped out.  Injection site has a 4-5" raised red splotch, which today, 3 days after injection, is still itchy and still red.  Injection site is very sore still.  Dose #1 gave me no reaction
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Nausea
Clinical narrative: Woke up morning after vaccine feeling nauseous, chills, achy, flushed., flu-like.  Exhausted.  Fell asleep talking on the phone multiple times because I was so wiped out.  Injection site has a 4-5" raised red splotch, which today, 3 days after injection, is still itchy and still red.  Injection site is very sore still.  Dose #1 gave me no reaction
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash macular, Somnolence
Clinical narrative: Woke up morning after vaccine feeling nauseous, chills, achy, flushed., flu-like.  Exhausted.  Fell asleep talking on the phone multiple times because I was so wiped out.  Injection site has a 4-5" raised red splotch, which today, 3 days after injection, is still itchy and still red.  Injection site is very sore still.  Dose #1 gave me no reaction
Age: 22.0
Sex: F
Vaccine: COVID19, FLUC4, HEP, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Intermittent scattered diffuse Hives with itching from 08/15/24 to 08/24/2024
Age: 71.0
Sex: M
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Injection site pain, Malaise, Pain, Pain in extremity
Clinical narrative: patient reported to pharmacy and said that he was sore all over and feeling under the weather.  Said that his arms were sore and aching.  I went over to the patient and asked if he was having trouble breathing or anything and he said he was not.  He said he was just really sore all over especially at injection site.  I told patient that he needs to keep cold compress on each injection site and alternate every 15 minutes and to keep hydrated and don't be out in the sun especially after more than 1 vaccine.  I printed out med guides to go over with patient and he stated that he understood that what he was experiencing was normal for vaccines due to the body producing antibodies in response to the vaccines given to him.  It was part of the immune response.  He said again that he was really sore, but I assured the patient that what he was experiencing was normal based on the side effects that are common with the Shingrix vaccine, flu vaccine, and Boostrix he received at the time.  I again told the patient to keep an eye out for any fever that may occur and to make sure to stay hydrated and to keep cold compress at inject site and to alternate every 15 minutes.  He said he didn't have any trouble breathing, but was just sore all over.
Age: 71.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: the patient developed a swollen, red, hot to the touch, hard area when pressing down  at the immunization site  reported by his daughter. The patient did visit the PCP and he was prescribed doxycycline antibiotic therapy for 7 days on 8/23/2024
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Super, extreme, evil,  all over muscle pain.  Getting out of bed to use the bathroom almost made me cry.                              Treatment- I spent all morning in bed.                                                     Time- By about 2:00pm  23Aug24, I felt fine except still soreness in right arm.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Dizziness, Hypoaesthesia, Hypopnoea, Muscle tightness
Clinical narrative: Approximately 5 minutes after the shot patient returns to the pharmacy saying that her back feels very tight, she is in pain, and she thinks she is having an adverse reaction to her flu shot. Patient come back into the clinical services room and sits down. Her back pain continues to increase to the point she begins to take shallow breaths and states that she feels like she is going to pass out. At this point EMS is contacted. The EMS representative recommends aspirin and we give aspirin. Patient states her feet feel like they are going numb. Patient then has her cell phone ring and she answers the phone. After a short conversation on the phone, her breathing calms and her pain seems to reduce. The EMS arrives and patient is able to walk, with the help of EMS worker, to the stretcher and is taken to the local emergency room.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis that vaccine site.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Neuralgia, Pain
Clinical narrative: Pt says has had nerve pain since receiving shot. Went to emergency room morning of 8/25/2024 due to symptoms of pain and discomfort
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient had a rash on her back from Duralumab  injection  from jan ,15 2024 she received 1 st shingrix vaccinne dose  in march . no reaction . she received the second shingrix dose in june 20 .  on july 4  patient stated that she started experiencing spots and  a rash and itching all over her body..
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Redness and swelling at the injection site which began 2 days after injection. Grew to be the diameter of a baseball. At 4 days after vaccine the patient began to develop urticaria on the arms, torso and neck. Patient experienced itching and discomfort that was not relieved by hydrocortisone cream. Patient experiences relief with an oral antihistamine. Unitarian persists at 10 days post vaccination.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Numbness and tingling in thumb of injection arm. Weakness in both arms now.
Age: 67.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Erythema, Peripheral swelling
Clinical narrative: She called saying she had a reaction in her right arm and it was red and swollen. i told her to apply a cold compress.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Vasovagal syncope following administration of vaccine, occurred within 5-10 minutes of administration. Provided patient with cold water and a sucker for sugar, she recovered within several minutes.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Syncope
Clinical narrative: Patient experienced vasovagal syncope following administration of the vaccine. I provided her with cold water and a sucker and she recovered within several minutes. No completed loss of consciousness, patient did feel like she was going to vomit but never did.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired healing, Peripheral swelling, Scab, Skin wound, Sleep disorder
Clinical narrative: pt described swollen deltoid and was tender he couldn't sleep on that side,. tender and swollen for over a week up to 2 weeks. red scabbed formed and is lingering on and off. small spot keeps opening and scabbing. . pt is concerned it wont heal. no pain described, only tiny local skin wound.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: pt described swollen deltoid and was tender he couldn't sleep on that side,. tender and swollen for over a week up to 2 weeks. red scabbed formed and is lingering on and off. small spot keeps opening and scabbing. . pt is concerned it wont heal. no pain described, only tiny local skin wound.
Age: 59.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Musculoskeletal stiffness, Seizure like phenomena, Tremor
Clinical narrative: no reported adverse events at time of administration. Wife called following day (8/25/24) and reported that she thought he had seizure like activity through the night and this has not occurred to her knowledge before. She mentioned him being straight and real stiff and body shook a couple of minutes at night. He has felt fine today (8/25/24) other than a little tired. Did not receive care from doctor/hospital.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient States that she has had painn in the arm ever since vacine given approximately 4 weeks ago .  Patient is going to follow up with PCP
Age: 67.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Abdominal rigidity, Nausea
Clinical narrative: after pt received his vaccine he stood up very quickly and tried to go back to work, 5 mins later he came back to say he was feeling a tightness in his stomach and maybe a little nausea. I told him to go have a seat and I will monitor him, I checked in on him every few mins to make sure he was feeling ok, after sitting for 15 mins pt felt fine and said he was ok and went back to work.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: I took my third dose on 9/28/2021. Three days later, when I woke up and tried to get out of bed, I felt as if I were paralyzed from the waist down. I grabbed the bed with my hands and go back in. I noticed that I couldn't bend my knees, so I started moving them slowly until heard them crack. Until today, I have problems with my knees and right arm .
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Three days after receiving her second Shingrix vaccine patient experienced a tingling sensation under the bottom of her toe that 6 days later has not gone away.   Patient says she has not experienced that before, and that it does not seem to be getting worse.   No adverse events to her first Shingrix vaccine.
Age: 67.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pruritus, Rash, Rash papular, Skin lesion
Clinical narrative: reddish papular lesions 1-2 mm diameter, some in linear rows on Right upper arm, Left lower arm, right side of waist. Itchy. Rash now for 5 days- new spots this morning.
Age: 56.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Pharmacist called to report expired dose of MMRII administered to patient; This spontaneous report was received from a pharmacist referring to a 56-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-AUG-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (lot #W039699, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 25-MAY-2024 [Expired product administered]; strength, and route of administration were not provided). Sterile diluent (MK-9395) was also administered as medication dilution (lot # W037058, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 27-JUN-2025; reported as concomitant therapy). No symptoms reported. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Age: 56.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; Pharmacist called to report expired dose of MMRII administered to patient; This spontaneous report was received from a pharmacist referring to a 56-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-AUG-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (lot #W039699, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 25-MAY-2024 [Expired product administered]; strength, and route of administration were not provided). Sterile diluent (MK-9395) was also administered as medication dilution (lot # W037058, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 27-JUN-2025; reported as concomitant therapy). No symptoms reported. There was no additional adverse event (AE) or product quality complaint (PQC) reported.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Tinnitus
Clinical narrative: constant ringing in the ear; This non-serious case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15 May 2024).   On 08-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, an unknown time after receiving Shingrix, the patient experienced ringing in ears (Verbatim: constant ringing in the ear). The outcome of the ringing in ears was not resolved.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.     It was unknown if the company considered the ringing in ears to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-AUG-2024 The reporter was the patient. He had Shingrix shot 2 on 08 Aug 2024 and ever since has had a constant ringing in the ear. He did not have the lot number.
Age: 63.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Arthralgia
Clinical narrative: Per the patient, beginning the following day, he experienced join pain in different fingers on both hands.  The symptoms lasted about 24 hours, and have since resolved.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: accidentally administered with pediatric doses of Engerix B to adult; accidentally administered with pediatric doses of Engerix B to adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: accidentally administered with pediatric doses of Engerix B to adult) and adult use of a child product (Verbatim: accidentally administered with pediatric doses of Engerix B to adult). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 15-AUG-2024 Healthcare professional explained that 3 adult patients were accidentally administered with pediatric doses of Engerix-B which led to adult use of a child product and accidental underdose. This case is linked with US2024101931, same reporter.; Sender's Comments:  US-GSK-US2024101931:2nd case for another two patient
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was accidently administered an expired dose of MMR II on 15-DEC-2020. Product expired on 12-DEC-2020.; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 15-DEC-2020, the patient was accidentally vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) injection as prophylaxis (dose, route of administration and anatomical location were not provided; lot number R035704 has been verified to be valid, expiration date reported as 12-DEC-2020, but upon internal validation established as 09-DEC-2020) (expired product administered). There were no prior temperature excursions reported. No additional adverse events were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2408USA006201:MSD
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Feeling abnormal, Heart rate increased, Mobility decreased, Pain
Clinical narrative: arm is still sore and I can't move it above my head; heart rate was high; feeling bad; arm cannot move above head; fever; chills; body aches/stinging sensation; This non-serious case was reported by a consumer and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included fludrocortisone.   On 07-AUG-2024, the patient received Bexsero .5 ml. On 07-AUG-2024, less than a day after receiving Bexsero, the patient experienced fever (Verbatim: fever), chills (Verbatim: chills) and general body pain (Verbatim: body aches/stinging sensation). On an unknown date, the patient experienced pain in arm (Verbatim: arm is still sore and I can't move it above my head), heart rate high (Verbatim: heart rate was high), feeling bad (Verbatim: feeling bad) and mobility decreased (Verbatim: arm cannot move above head). The outcome of the fever, chills and general body pain were resolving and the outcome of the pain in arm and mobility decreased were not resolved and the outcome of the heart rate high was not reported and the outcome of the feeling bad was resolved.   It was unknown if the reporter considered the fever, chills, general body pain, pain in arm, heart rate high, feeling bad and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, chills, general body pain, pain in arm, heart rate high, feeling bad and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-AUG-2024 The patient had a fever of 102.7, body felt like it was stinging me, heart rate was high, chills, bodyaches. The patient felt bad for 2 days. The outcome date reported for events fever, chills, general body pain was 09 August 2024. The patient's arm was still sore and cannot move above head.  The patient had fever, chills, body aches, stinging sensation.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm is still sore and I can't move it above my head; heart rate was high; feeling bad; arm cannot move above head; fever; chills; body aches/stinging sensation; This non-serious case was reported by a consumer and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included fludrocortisone.   On 07-AUG-2024, the patient received Bexsero .5 ml. On 07-AUG-2024, less than a day after receiving Bexsero, the patient experienced fever (Verbatim: fever), chills (Verbatim: chills) and general body pain (Verbatim: body aches/stinging sensation). On an unknown date, the patient experienced pain in arm (Verbatim: arm is still sore and I can't move it above my head), heart rate high (Verbatim: heart rate was high), feeling bad (Verbatim: feeling bad) and mobility decreased (Verbatim: arm cannot move above head). The outcome of the fever, chills and general body pain were resolving and the outcome of the pain in arm and mobility decreased were not resolved and the outcome of the heart rate high was not reported and the outcome of the feeling bad was resolved.   It was unknown if the reporter considered the fever, chills, general body pain, pain in arm, heart rate high, feeling bad and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fever, chills, general body pain, pain in arm, heart rate high, feeling bad and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-AUG-2024 The patient had a fever of 102.7, body felt like it was stinging me, heart rate was high, chills, bodyaches. The patient felt bad for 2 days. The outcome date reported for events fever, chills, general body pain was 09 August 2024. The patient's arm was still sore and cannot move above head.  The patient had fever, chills, body aches, stinging sensation.
Sex: M
Vaccine: COVID19, HEPA, MEN, MENB
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of pain in arm in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Hepatitis A vaccine (batch number X2598) for prophylaxis, Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) (batch number U7949AA) for prophylaxis and ELASOMERAN (batch number AU5558B) for prophylaxis.   On 03-MAY-2024, the patient received Bexsero, Hepatitis A vaccine (intramuscular), Menquadfi (intramuscular) and ELASOMERAN (intramuscular) .25 ml. On 03-MAY-2024, less than a day after receiving Bexsero and Hepatitis A vaccine, the patient experienced pain in arm (Verbatim: Arm pain). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Hepatitis A vaccine.     It was unknown if the company considered the pain in arm to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Hepatitis A vaccine.   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: 12-AUG-2024 It was reporter that after receiving Bexsero and Hepatitis A vaccine, Menquadfi, Elasomeran  the patient experienced pain in arm. It was unknown if the company considered the pain in arm to be related to Menquadfi and Elasomeran.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: tendor upper arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In AUG-2024, the patient received the 1st dose of Shingles vaccine. In AUG-2024, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: tendor upper arm). In AUG-2024, the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-AUG-2024 The reporter stated that just had the first shot of shingles vaccine a week or so ago, second scheduled for in about 2 months.  The shot was no big deal, no more of a prick than a flu shot and he/she had no side effects other than a tender upper arm for a few days.  The reporter further stated that did it and no, really, just did it.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-AUG-2024 Reporter mentioned patients move from out of state and have received only one dose of Shingrix more than 6 months ago happens lot for her. No further details shared. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The case is linked with US2024100827, same reporter.; Sender's Comments:  US-GSK-US2024100827:same reporter diff patient
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product preparation issue
Clinical narrative: administered the vaccine without the vigorously shaking well prior administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced inappropriate reconstitution technique (Verbatim: administered the vaccine without the vigorously shaking well prior administration). The outcome of the inappropriate reconstitution technique 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: 12-AUG-2024 Caller reported one of the nurses said that she did not, she may not shaked Pediarix before administrate the vaccine. The reporter stated I wonder if you had any data or any information about administer the vaccine without the vigorously shaking well prior administration which led to inappropriate reconstitution technique. Caller did not have any information of the patient or the vaccine (lot number and expiration date). He also said that one of the nurse did shake the vaccine, but other person in the vaccine room said that they did not see this, that was why he said that it may not shake Pediarix before administer the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received the first dose of Shingrix 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-AUG-2024 The patient received first dose and never received the second dose of Shingrix. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 61.0
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 61 year old, male patient that received a dose of Menveo; 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 61-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 20-APR-2025) for prophylaxis.   On 12-AUG-2024, the patient received Menveo (intraparietal, unknown arm). On 12-AUG-2024, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 61 year old, male patient that received a dose of Menveo). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 14-AUG-2024 The patient received Menveo at inappropriate age which led inappropriate age at vaccine administration.  The reporter consented to follow up.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 4 months old male baby received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Concomitant products included Pediarix.   On 09-AUG-2024, the patient received Kinrix. On 09-AUG-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 4 months old male baby received Kinrix). 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: 14-AUG-2024 A 4 months old male patient received Kinrix, which led inappropriate age at vaccine administration.  The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B that expired 2 days ago was administered today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B) (batch number ZY7D9, expiry date 12-AUG-2024) for prophylaxis.   On 14-AUG-2024, the patient received the 1st dose of Engerix B. On 14-AUG-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B that expired 2 days ago was administered today). 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: 14-AUG-2024 The pharmacist stated that an Engerix-B vaccine that expired 2 days ago was administered today (on the reporting day), which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter The reporter consent to follow up via postal.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: incorrect preparation; incorrect preparation; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-year-old male patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: incorrect preparation) and inappropriate dose of vaccine administered (Verbatim: incorrect preparation). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   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: 15-AUG-2024 The patient was given just the diluent was given to a patient and not the vaccine portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. 5 potential patients were involved. Nurse provided Patient's initials, gender and age, she said that she did not have the exact date of birth. HCP stated that the Safety team on the clinic that she's working in is following the case and that the Patient's parents have been notified. This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024101909:Same reporter, different patient US-GSK-US2024101918:Same reporter, different patient US-GSK-US2024101901:Same reporter, different patient
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: where just  the diluent was given to a patient and not the vaccine portion; where just  the diluent was given to a patient and not the vaccine portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old female patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: where just  the diluent was given to a patient and not the vaccine portion) and inappropriate dose of vaccine administered (Verbatim: where just  the diluent was given to a patient and not the vaccine portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2024 The registered nurse reported that they had a situation where just the diluent was given to a patient and not the vaccine portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. It was reported that 5 potential patients were involved This was 1 of the 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024101918:Same reporter, different patient US-GSK-US2024101901:Same reporter, different patient US-GSK-US2024101907:Same reporter, different patient US-GSK-US2024101892:Same reporter, different patient
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Single component of a two-component product administered, Underdose
Clinical narrative: the diluent was given to a patient and not the vaccine portion; the diluent was given to a patient and not the vaccine portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 1-year-old female patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: the diluent was given to a patient and not the vaccine portion) and inappropriate dose of vaccine administered (Verbatim: the diluent was given to a patient and not the vaccine portion). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   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: 15-AUG-2024 The registered nurse reported that the diluent was given to a patient and not the vaccine portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is 1 of the 5 linked case, by same reporter.; Sender's Comments:  US-GSK-US2024101901:Same reporter, different patient US-GSK-US2024101909:Same reporter, different patient US-GSK-US2024101907:Same reporter, different patient US-GSK-US2024101892:Same reporter, different patient
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse said that they have been applying Boostrix to patients of 7 years and older.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patients received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Nurse said that they have been applying Boostrix to patients of 7 years and older.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 15-AUG-2024 Nurse stated in general that in the past that they had been applying Boostrix to patients of 7 years and older, which led inappropriate age at vaccine administered.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: A 19 months old baby received an adult dose of Havrix.; Overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 19-month-old male patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced adult product administered to child (Verbatim: A 19 months old baby received an adult dose of Havrix.) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose 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: 15-AUG-2024 A 19 months old patient received an adult dose of Havrix, which led adult product administered to child and overdose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their 1st dose (Shingrix) and it's been,over a year/late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received their 1st dose (Shingrix) and it's been,over a year/late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-AUG-2024 The reporter asked if they would have to restart the series or was something that they just continue the Shingrix. The reporter did not know where the patient get the 1st dose reject the follow up from safety team. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: RSV
Symptoms: Paraesthesia
Clinical narrative: tingling in his lower left extremities.; This non-serious case was reported by a consumer via sales rep and described the occurrence of tingling of extremity in a 64-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced tingling of extremity (Verbatim: tingling in his lower left extremities.). The outcome of the tingling of extremity was not resolved.   It was unknown if the reporter considered the tingling of extremity to be related to Arexvy.     It was unknown if the company considered the tingling of extremity to be related to Arexvy.   Additional Information: GSK receipt date: 15-AUG-2024 Reporter was an Arexvy representative for GlaxoSmithKline. Reporter stated she was visiting a healthcare office and the Nurse Practitioner was telling about his adverse event of tingling in his lower left extremities. This adverse event was still ongoing.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: an adult accidentally received a dose of Infanrix/Administration in adult; an adult accidentally received a dose of Infanrix/Administration in adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 40-year-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On 15-AUG-2024, the patient received Infanrix. On 15-AUG-2024, an unknown time after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: an adult accidentally received a dose of Infanrix/Administration in adult) and wrong vaccine administered (Verbatim: an adult accidentally received a dose of Infanrix/Administration in adult). The outcome of the adult use of a child product and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2024 The medical assistant reported that an adult patient accidentally received a dose of Infanrix vaccine, which led to adult use of a child product and wrong vaccine administered. The healthcare professional would like to know how to proceed. The reporter provided information about vaccine, event and patient.  The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Product preparation issue
Clinical narrative: Patient complained of arm pain at injection site; HCP did not reconstitute vaccine, adjuvant liquid component administered no lyophilized antigen given; HCP did not reconstitute vaccine, adjuvant liquid component administered no lyophilized antigen given; This non-serious case was reported by a physician and described the occurrence of injection site pain in a 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 injection site pain (Verbatim: Patient complained of arm pain at injection site), inappropriate dose of vaccine administered (Verbatim: HCP did not reconstitute vaccine, adjuvant liquid component administered no lyophilized antigen given) and inappropriate preparation of medication (Verbatim: HCP did not reconstitute vaccine, adjuvant liquid component administered no lyophilized antigen given). The outcome of the injection site pain was not reported and the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were resolved.   The reporter considered the injection site pain to be related to Shingrix.     The company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt date: 15-AUG-2024 A reporter reported that the HCP did not reconstitute vaccine, adjuvant liquid component administered, no lyophilized antigen given which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered Patient complained of arm pain at injection site.