chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Refrigerator temperature was out of range sporadically with the lowest temperature reaching 23.6 degrees F in the five days prior to the vaccine being given. Seqirus was contacted and stated the vaccine is no longer valid and a repeat dose will be needed.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Staring, Unresponsive to stimuli, Ventricular tachycardia
Clinical narrative: PT'S WIFE CAME IN TODAY TO REPORT HER HUSBAND'S ADVERSE REACTION TO THE COVID VACCINE (SPIKEVAX) ADMINISTERED NOV 30, 2023. SHE STATED LESS THAN 12 HOURS AFTER ADMINISTRATION THAT NIGHT SHE OBSERVED HER HUSBAND BEING AWAKE BUT UNRESPONSIVE, HAD A "BLANK STARE" AND DID NOT RESPOND TO HER SPEAKING AND SHAKING HIM. SHE CALLED EMS WHO CAME AND SAW HE WAS EXPERIENCING VENTRICULAR TACHYCARDIA. HE HAS A DEFIBRILLATOR THAT WAS IMPLANTED ABOUT 8 WEEKS PRIOR. SHE REPORTS HE HAD A BAD REACTION UPON RECEIVING A COVID VACCINE LAST YEAR BUT WAS UNKNOWN IF HE WENT INTO V TACH AS HE DID NOT HAVE A DEFIBRILLATOR PLACED AT THAT TIME. SHE NOTED THE REACTION WAS SEVERE ENOUGH LAST YEAR TO MAKE THEM CONCLUDE AFTER THIS YEAR'S COVID VACCINE THAT HE CAN NOT TOLERATE PFIZER OR MODERNA COVID VACCINES. SHE STATED HE HAD NO SUCH REACTION WITH JOHNSON & JOHNSON VACCINE. HE HAS SUBSEQUENTLY BEEN RELEASED FROM THE HOSPITAL AS OF THIS PAST MONDAY DEC 4,2023 AND IS RECOVERING WELL.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat, chills, headache
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Refrigerator temperature was out of range sporadically with the lowest temperature reaching 23.6 degrees F in the five days prior to the vaccine being given. Seqirus was contacted and stated the vaccine is no longer valid and a repeat dose will be needed.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Arthralgia, Back pain, Chills, Immunisation reaction, Injected limb mobility decreased
Clinical narrative: She got her vaccines, she went home.  Then later in teh afternoon her and her husband ran an errand and had an early dinner.  The RSV vaccine in the left arm gave her fever and chills, and body aches for about 20 hours, and was fine the next day, went away about as quickly as it came.  In her right arm she had the typical vaccine reaction that she thought, a little bit of soreness.  By that evening she mentioned to her husband that her arm hurt, and that maybe it was not a good idea to get both in the same arm.  By the next days the areas got worse and on 11/7/23 she called her PCP and continued her normal daily activities.  The symptoms of arm pain is what got worse, in the shoulder area where the band-aide was put It spread down her arm, across her shoulder blades to the middle of her back.  she had a regular APT scheduled for 11/13/23 and called on 11/7/23 and said he would see her on the 13th.  She was sent for an US of her shoulder, and the findings show that her rotator tendon in her arm had completely torn off the bone and turned to mush.  She was told that she needed to see an orthopedic surgeon, she went there and she is scheduled for an MRI on 12/22/23.    She did not have any shoulder issues or pain prior to the vaccine.  She is very active, she gardens, paints and does a lot of things with her shoulder, and never had any shoulder pain until the afternoon of the vaccine.    She has a full thickness tear of the supraspinatus approximately 1.5 cm.    She has limited use of her right arm, in a lot of pain.  She was not given anything for her shoulder pain.  She does go to a pain management clinic for her sacroiliitis and is taking Tramadol for that.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: She got her vaccines, she went home.  Then later in teh afternoon her and her husband ran an errand and had an early dinner.  The RSV vaccine in the left arm gave her fever and chills, and body aches for about 20 hours, and was fine the next day, went away about as quickly as it came.  In her right arm she had the typical vaccine reaction that she thought, a little bit of soreness.  By that evening she mentioned to her husband that her arm hurt, and that maybe it was not a good idea to get both in the same arm.  By the next days the areas got worse and on 11/7/23 she called her PCP and continued her normal daily activities.  The symptoms of arm pain is what got worse, in the shoulder area where the band-aide was put It spread down her arm, across her shoulder blades to the middle of her back.  she had a regular APT scheduled for 11/13/23 and called on 11/7/23 and said he would see her on the 13th.  She was sent for an US of her shoulder, and the findings show that her rotator tendon in her arm had completely torn off the bone and turned to mush.  She was told that she needed to see an orthopedic surgeon, she went there and she is scheduled for an MRI on 12/22/23.    She did not have any shoulder issues or pain prior to the vaccine.  She is very active, she gardens, paints and does a lot of things with her shoulder, and never had any shoulder pain until the afternoon of the vaccine.    She has a full thickness tear of the supraspinatus approximately 1.5 cm.    She has limited use of her right arm, in a lot of pain.  She was not given anything for her shoulder pain.  She does go to a pain management clinic for her sacroiliitis and is taking Tramadol for that.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Rotator cuff syndrome, Sacroiliitis, Tendon disorder, Ultrasound joint, Ultrasound joint abnormal
Clinical narrative: She got her vaccines, she went home.  Then later in teh afternoon her and her husband ran an errand and had an early dinner.  The RSV vaccine in the left arm gave her fever and chills, and body aches for about 20 hours, and was fine the next day, went away about as quickly as it came.  In her right arm she had the typical vaccine reaction that she thought, a little bit of soreness.  By that evening she mentioned to her husband that her arm hurt, and that maybe it was not a good idea to get both in the same arm.  By the next days the areas got worse and on 11/7/23 she called her PCP and continued her normal daily activities.  The symptoms of arm pain is what got worse, in the shoulder area where the band-aide was put It spread down her arm, across her shoulder blades to the middle of her back.  she had a regular APT scheduled for 11/13/23 and called on 11/7/23 and said he would see her on the 13th.  She was sent for an US of her shoulder, and the findings show that her rotator tendon in her arm had completely torn off the bone and turned to mush.  She was told that she needed to see an orthopedic surgeon, she went there and she is scheduled for an MRI on 12/22/23.    She did not have any shoulder issues or pain prior to the vaccine.  She is very active, she gardens, paints and does a lot of things with her shoulder, and never had any shoulder pain until the afternoon of the vaccine.    She has a full thickness tear of the supraspinatus approximately 1.5 cm.    She has limited use of her right arm, in a lot of pain.  She was not given anything for her shoulder pain.  She does go to a pain management clinic for her sacroiliitis and is taking Tramadol for that.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Loss of consciousness
Clinical narrative: AFTER RECEIVING SHOT PATIENT SAT DOWN AND WAITINED ON THE OTHER THREE PEOPLE GETTING THEIR FLU SHOTS. THEN THE PATIENT GOT UP IN THE WAITING AREA TALKING WITH HER MOTHER THAT WAS STANDING BESIDE HER, AND THE PATINET PASSED OUT FALLING DOWN AND HER MOTHER CATCHING HER. MY CO WORKER WAS IN WAITNG AREA AS WELL AND YELLED FOR ME.  WHEN I GOT TO THE PATIENT HER EYES WERE OPEN AND SHE SAID SHE FELT FINE.  SHE SAID SHE JUST MUST HAVE GOTTEN A LITTLE DIZZY. I MADE HER SIT UP SLOWLY AND THEN GOT HER INTO A CHAIR AND MADE HER WAIT 15 MINUTES.  AS SHE WAS WAITNING SHE ASKED FOR WATER WHICH I GAVER HER, AND HER MOTHER ASKED FOR SOMETHING SWEET SO I GAVE HER SOMETHING SWEET. AFTER 15 MINUTES SHE SAID SHE WAS STILL FEELING FINE. I ADVISED HER AND HER MOTHER THAT IF SHE STARTED FEELING BAD AGAIN AND WAS CLOSE TO PHARMACY TO COME BACK AND I WOULD HELP, OR TO CALL 911 AND SEEK MEDICAL ATTENTION.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Patient states that she has swelling and redness down her arm from the vaccination site.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Pyrexia, Rash erythematous
Clinical narrative: Patient experienced fever symptoms same day as vaccination. Starting on 12/8/23 patient had red rash and swelling in arm at vaccination site. Patient advised to try benadryl to help with symptoms but if no improvement or worsening of symptoms to go to urgent care. Patient had been taking tylenol to try and help with symptoms thus far.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Refrigerator temperature was out of range sporadically with the lowest temperature reaching 23.6 degrees F in the five days prior to the vaccine being given. Seqirus was contacted and stated the vaccine is no longer valid and a repeat dose will be needed.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Oropharyngeal pain, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: Sore throat, sinus congestin
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Heart rate increased, Oropharyngeal pain
Clinical narrative: Patient started having an elevated heart rate, lightheadedness, and a sore throat.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient became very lightheaded and slight nausea/vomiting minutes after receiving vaccine. She relaxed for 15 minutes post vaccine and left store feeling better.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Axillary pain, Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Local injection site reaction.  Localized reaction at injection site.  Redness encompassing  right shoulder and deltoid area, swelling noted right upper arm  deltoid, pain radiating from right shoulder to right deltoid and right axillary areas.   Patient with pain on movement and use of right arm.  Reaction started within 2 hours of injection lasting 4-5 days.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Felt normal soreness for a couple days and then noticed the pain becoming more painful and going down her arm towards her elbow. At time of call on 12/6/2023 she was still experiencing the pain.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccination comirnaty was put into the refrigerator on 9/25/23. Use by date was 12/4/23. Vaccine was administered on 12/5/23. I called Pfizer to confirm if this was a vaccination error and the nurse confirmed that it was indeed a vaccination error. I called the patient to confirm any side-effects, but there was no answer. I left a message for the patient to call the pharmacy at the earliest convenience. I will report incident to the Vaccine Adverse Event Reporting System (VAERS) and follow-up with patient. I also left a message with staff from his primary care doctor's office. Going forward, plan of action is to make sure every vaccination has a CLEAR and distinct use by date on each vial and box of immunizations.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Refrigerator temperature was out of range sporadically with the lowest temperature reaching 23.6 degrees F in the five days prior to the vaccine being given. Seqirus was contacted and stated the vaccine is no longer valid and a repeat dose will be needed.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: Sinus pressure, coughing
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Refrigerator temperature was out of range sporadically with the lowest temperature reaching 23.6 degrees F in the five days prior to the vaccine being given. Seqirus was contacted and stated the vaccine is no longer valid and a repeat dose will be needed.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Refrigerator temperature was out of range sporadically with the lowest temperature reaching 23.6 degrees F in the five days prior to the vaccine being given. Seqirus was contacted and stated the vaccine is no longer valid and a repeat dose will be needed.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: Refrigerator temperature was out of range sporadically with the lowest temperature reaching 23.6 degrees F in the five days prior to the vaccine being given. GSK was contacted and stated the vaccine is no longer valid and a repeat dose will be needed.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness
Clinical narrative: Pt received vaccines a few minutes after she passed out and fell headfirst on the floor. Pt stated she had not eaten anything all day she was monitored by nurse , provider, and medical assistant for about 30 mins. she was then feeling better to go home.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient was given a high dose flu vaccine instead of the regular Flulaval.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccination comirnaty was put into the refrigerator on 9/25/23. Use by date was 12/4/23. Vaccine was administered on 12/5/23. I called Pfizer to confirm if this was a vaccination error and the nurse confirmed that it was indeed a vaccination error. I called the patient to confirm any side-effects, but there was no answer. I left a message for the patient to call the pharmacy at the earliest convenience. I will report incident to the Vaccine Adverse Event Reporting System (VAERS) and follow-up with patient. I also left a message with his primary care doctor's office. Going forward, plan of action is to make sure every vaccination has a CLEAR and distinct use by date on each vial and box of immunizations.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Visual red spot on arm, around 3.5 inches in diameter, warm to touch, itching and not hurting otherwise.  Patient will use topical hydrocortisone, benadryl, and tylenol or ibuprofen for pain.  Patient aware of when she should contact a provider.
Age: 9.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given dose of PCV 13 out of recommended age range, due to not having any previous vaccine records. Pt is not a high risk. Pt showed no reaction to vaccine.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Lip swelling, Swelling face
Clinical narrative: Patient stated she noticed that her lips and face were swelled up at 6 am 12/6/23. Patient stated she took Benadryl for 2 days. The swelling is now resolved.
Age: 64.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: patient said she was sore by the evening and by the next day she could not turn her neck.  This has continued for 7 days and she is still not able to turn.  She received a steroid shot and is getting  medications to treat pain and inflammation.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardiac monitoring, Electrocardiogram abnormal, Fatigue, Heart rate decreased
Clinical narrative: PATIENT INITIALLY REPORTED FATIGUE BUT WHEN THEY READ THEIR HEART RATE IT WAS VERY LOW, DOWN AROUND THE 40'S WHICH IS UNUSUAL FOR HER, SHE ALSO REPORTED RAPID INCREASES UP TO 100.  PATIENT ENDED UP GOING TO THE ER AND WAS FOUND TO HAVE AFIB ON 12/4
Age: 9.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient received flu shot at md office before coming to pharmacy to get Prevnar 20 shot at 9:45am 12/7/2023; afternoon while at school - swollen arm from shoulder to elbow with pain, treated with ibuprofen and ice packs.  Swelling and pain continued through night and next day; mother contacted pharmacy to inform us of reaction - per mother seemed stable at 3:00pm 12/8/2023 (not better but not worse).
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia
Clinical narrative: Generalized weakness
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity
Clinical narrative: Body soreness, chills at 2200 12/7/2023; followed by persistent slight-moderate headache. Headache lasted 12-18hours. Alternated between Advil and Tylenol to relieve affects from headache. Upper right arm moderately sore.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered
Clinical narrative: INADVERENTLY GAVE AN EXTRA DOSE OF BOTH VACCINES ON 11/27/2023 VISIT. PATIENT RECEIVED THESE VACCINES ON 11/13/2023.  VACCINES HAD NOT BEEN ENTERED INTO THE IMMUNIZATION SYSTEM AND WAS NOT SHOWING ON THE VACCINE RECORD.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Accidental exposure to product, Injury associated with device
Clinical narrative: Our nurse received a needlestick after the vaccine administration. She was trying to activate the safety mechanism on the needle and it failed.
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Diarrhoea, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states starting 4 days post vaccination began having diarrhea lasting about 3 days, and bilateral shoulder pain which has slowly progressed as of 12/8/23. Patient also reports progressive pain and swelling in the hands beginning approximately 2 weeks after vaccination, has continued to progressively get worse as of 12/8/2023. Patient advised by pharmacy to contact PCP, patient is on hydrocodone/apap 10/325 for knee pain and states is not helping with hand or shoulder pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient complaining of extremely sore arm and numb thumb
Age: 76.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Fall, Femur fracture, Syncope
Clinical narrative: The day after patient received 2 vaccines, she fainted with no warning symptoms and fell and broke the femur bone in her leg.    She was revived and consequently treated for the broken leg and spent a month in a rehabilitation facility.  She is recovering at home now and wanted to report that it is possible the RSV vaccine caused her to faint since she had read this is a possibility on line.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, HPV9
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Wrong product administered
Clinical narrative: Mother called and left message stating patient has developed knots and reddness at her injection sites beginning on 12/06/2023 , when mother called on 12/7/2023 to leave a message she stated they were getting larger and the redness was spreading. Note sent to PCP and Provider advised normal reaction and to use ice packs, hydrocortisone cream. Mother was contacted same day as the message and she stated no change but verbalized understanding of treatment plan along with Tylenol as needed and to contact our office 1st thing in the morning if no change to make an appointment to be seen. As of 12/8/2023 at 1345 mother has not contacted the office. 12/8/2023 mother contacted and informed of incorrect vaccine.  Mother advised patient is doing much better and swelling and reddness have gone down.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: Immediate post-injection reaction, Rash, Rash erythematous
Clinical narrative: WITHIN A MINUTE AFTER THE ROTARIX AND VACINES WERE GIVEN, THE PATIENTS FACE STARTED BREAKING OUT IN RED PATCHES. HER CHEST AND ABDOMEN BROKE OUT AS WELL. THE RESIDENT, DR, CAME IMMEDIATELY TO CHECK VITALS, OBSERVE THE BABY, ASESS HER BREATHING AND WATCH HER. SHE ORDERED US TO ADMINISTER 2ML OF BENADRYL AND WATCH THE PT. THE RASH/RED PATCHES WENT AWAY WITHIN 10 MINUTES AND THE PT WAS NOT IN DSITRESS. DR ADVISED THAT SHE WILL BE IN HE ROOM FOR THE 6 MONTH OLF VACCINES, TO SIRECTLY OBSERVE THE PATIENT.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: redness and swelling progressively getting worse. patient visited doctor and they determined it was cellulitis.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Joint swelling, Product administered at inappropriate site
Clinical narrative: Injected incorrectly mid arm subcutaneously below the deltoid muscle. Large swelling and increased heat at injection site. Severe headaches. Mild fever 100.1 Previous vaccinations had more mild reactions and no injection site swelling
Sex: F
Vaccine: RSV, RVX
Symptoms: Immediate post-injection reaction, Rhinorrhoea
Clinical narrative: runny nose; This non-serious case was reported by a consumer and described the occurrence of runny nose in a 65-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number 00069034405) for prophylaxis.   Co-suspect products included RSV VACCINE PROT. SUBUNIT PREF 2V (ABRYSVO) (batch number 00069034405) for prophylaxis.   Additional patient notes included her lungs are clear and she not contagious and she did not have Covid.   On an unknown date, the patient received RSV vaccine and ABRYSVO. On an unknown date, immediately after receiving RSV vaccine, the patient experienced runny nose (Verbatim: runny nose). The outcome of the runny nose was not resolved.   It was unknown if the reporter considered the runny nose to be related to RSV vaccine.     It was unknown if the company considered the runny nose to be related to RSV vaccine.   Additional Information: RA Receipt date: 29-NOV-2023  A patient reported for her-self. She stated that immediately, she started had a runny nose and saw doctor and it did not seem to be in the allergy and her lungs were clear and she was not contagious.  She did not have Covid and it's been going on ever since and her symptoms not treated. It was unknown if the reporter considered the runny nose to be related to Abrysvo. The reporter had permission to contact.
Sex: U
Vaccine: RSV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Pain in arm; sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a 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 fever (Verbatim: Fever), pain in arm (Verbatim: Pain in arm) and pain (Verbatim: sore). The outcome of the fever and pain were not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the fever, pain in arm and pain to be related to Arexvy.     It was unknown if the company considered the fever, pain in arm and pain to be related to Arexvy.   Additional Information: GSK Receipt date: 29-NOV-2023 This case was reported by patient via (Open field AE monitoring) interactive digital media. The patient reported that Injected (illegible) fever through (illegible) (101.8 degree F max) arm still (illegible) and sore. The patient wanted to know what to do for pain in arm. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Patient was given the diluent and no adjuvant; Patient was given the diluent and no adjuvant; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 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 inappropriate preparation of medication (Verbatim: Patient was given the diluent and no adjuvant) and inappropriate dose of vaccine administered (Verbatim: Patient was given the diluent and no adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:30-NOV-2023 The patient was given the diluent and no adjuvant.  They were investigating to uncover who the patient was and will recall them to give the full vaccine. The patient received only diluent of Arexvy, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: pain at the injection site in the arm; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: pain at the injection site in the arm). The outcome of the injection site pain was resolved (duration 1 week).   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain 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: 29-NOV-2023 The physician mentioned long lasting arm pain. The physician reported the patient was reported pain at injection site in the arm that lasted roughly a week. The patient resolved without further incidence. The reporter consent to followup.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: third dose of Shingrix was inadvertently administered; requested for an RSV vaccine but inadvertently administered shingrix vaccine; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received dose 2nd dose of shingrix at least 3 years ago) and Shingrix (Received 1st dose of shingrix).   On 28-NOV-2023, the patient received the 3rd dose of Shingrix .5 ml. On 28-NOV-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: third dose of Shingrix was inadvertently administered) and wrong vaccine administered (Verbatim: requested for an RSV vaccine but inadvertently administered shingrix vaccine). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-NOV-2023 The reporter was a GSK staff employee. The reporter reported that patient received 3rd dose of Shingrix vaccine inadvertently on 28th November 2023 which led to extra dose administered. The patient actually requested for RSV vaccine but patient received Shingrix vaccine which led to wrong vaccine administered. As per the reporter patient did not have a good experience with side effects from her second dose and was very worried about how she will react now. Since she was not supposed to get three doses of Shingrix. The reporter agrees to follow up from GlaxoSmithKline.
Age: 0.33
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Nurse reports a 4 month old patient was inadvertently given a flu shot.; 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 Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number BB222) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced inappropriate age at vaccine administration (Verbatim: Nurse reports a 4 month old patient was inadvertently given a flu shot.). 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: 28-NOV-2023 The Nurse reported a 4 month old patient was inadvertently given a flu shot, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Inappropriate schedule of product administration
Clinical narrative: going to received the second dose today; going to received the second dose today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (4 years ago received 1st dose.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: going to received the second dose today) and drug dose administration interval too long (Verbatim: going to received the second dose today). The outcome of the circumstance or information capable of leading to medication error and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt date: 28-NOV-2023 A pharmacist reported that a patient got the first dose of Shingrix 4 years ago and the patient was going to receive the second dose today and the HCP asked if the patient needs to re start the series. The patient going to receive 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule and Circumstance or information capable of leading to medication error. The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who received 1st Shingrix dose in 2020 and 2nd Shingrix dose on 03/2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   In MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: patient who received 1st Shingrix dose in 2020 and 2nd Shingrix dose on 03/2023). The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK receipt date: 28 Nov 2023 The pharmacist reported that a patient who received 1st Shingrix dose in 2020 and 2nd Shingrix dose on March 2023, which led to inappropriate schedule of vaccine administered. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 3 years old male patient received Boostrix shot today by mistake; 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 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number KP547, expiry date 29-NOV-2024) for prophylaxis.   On 28-NOV-2023, the patient received Boostrix. On 28-NOV-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 years old male patient received Boostrix shot today by mistake). 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:28-NOV-2023 The reporter was a clinic supervisor. The reporter reported that a 3 years old male patient received Boostrix shot on the day of reporting by mistake, which led to inappropriate age at vaccine administration. According to the reporter the patient was fine. Treating physician was aware of that event. The reporter did not consent to follow up. This case is linked with US2023166465, reported by same reporter.; Sender's Comments:  US-GSK-US2023166465:Same Patient
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Rotarix diluent was administered without reconstitution with lyophilized portion of the vaccine to 2 patients; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 9-week-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 5279E, expiry date 25-FEB-2024) for prophylaxis.   On 13-JUL-2023, the patient received Rotarix lyophilized formulation. On 13-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Rotarix diluent was administered without reconstitution with lyophilized portion of the vaccine to 2 patients) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). 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: 28-NOV-2023 The health care professional reported that Rotarix diluent was administered without reconstitution with lyophilized portion of the vaccine to the patient. The patient received only diluent of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with US2023166471 The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023166471:Same Reporter , same Product .
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: she has developed Fever Blisters; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included aciclovir (Acyclovir).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever blister (Verbatim: she has developed Fever Blisters). The outcome of the fever blister was not resolved.   It was unknown if the reporter considered the fever blister to be related to Shingrix.     It was unknown if the company considered the fever blister to be related to Shingrix.   Additional Information: RA receipt date: 28-NOV-2023 The reporter stated that she had developed fever blisters.  The reporter did not specify if she had the fever blisters before she got her first Shingrix vaccine.  That was not resolved.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: shorter than recommended interval between 2nd dose and 3rd dose had; longer than recommended between 1st and 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Previously administered products included Pediarix (On August 2021 received 1st dose at 2 month of age.).   On 30-NOV-2021, the patient received the 3rd dose of Pediarix. On 09-NOV-2021, the patient received the 2nd dose of Pediarix. On 09-NOV-2021, not applicable after receiving Pediarix and an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: longer than recommended between 1st and 2nd dose). On 30-NOV-2021, the patient experienced drug dose administration interval too short (Verbatim: shorter than recommended interval between 2nd dose and 3rd dose had). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt date: 29-NOV-2023 A nurse reported that the first dose of Pediarix was given to a 2-month-old patient in August 2021 and then the second dose was administered when patient was 5 months old in 09 November 2021 longer than recommended between doses for the schedule and third dose on 30 November 2021.  The patient received 2nd dose of Pediarix later than the recommended interval, which led to lengthening of the vaccine schedule. The patient received 3rd dose of Pediarix shorter than the recommended interval, which led to Drug Shortening of the vaccine schedule. The reporter consented to follow up by email.
Sex: F
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: a patient who came in with a prescription for Arexvy, but she is not 60 years of age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included diabetes and heart disorder.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: a patient who came in with a prescription for Arexvy, but she is not 60 years of age). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK receipt date: 29-NOV-2023 A pharmacist reported that he had a patient who came in with a prescription for Arexvy, but she was not 60 years of age. The reporter was not sure who to put under health care professional details, so they put the prescribing doctor's information for follow up as well. The pharmacist had not given the Arexvy to the patient because she was not 60 at the time, which led to intercepted drug prescribing error. The reporter consented to follow up.
Age: 7.0
Sex: M
Vaccine: HEPAB
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: they were meant to receive Twinrix Junior; they were meant to receive Twinrix Junior; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 7-year-old male patient who received HAB (Twinrix adult) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Hepatitis A (received 2 doses of hepatitis A vaccine on an unknown date) and Hepatitis B (received 5 doses of Hepatitis B vaccine on an unknown date).   On 29-NOV-2023, the patient received Twinrix adult. On 29-NOV-2023, an unknown time after receiving Twinrix adult, the patient experienced adult product administered to child (Verbatim: they were meant to receive Twinrix Junior) and overdose (Verbatim: they were meant to receive Twinrix Junior). 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-29-NOV-2023 The nurse reported that the child patient were administered a dose of Twinrix adult. The patient had previously received hepatitis A 2 doses and hepatitis B 5 doses. The nurse stated they were meant to receive Twinrix Junior, but this product was not available in specific country. The child patient were administered a dose of Twinrix adult, which led to adult product administered to child and overdose. this case is linked to same reporter for different patient for any tolerance please refer case US2023167168 The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023167168:Patient 2
Age: 7.0
Sex: M
Vaccine: HEPAB
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: they were meant to receive Twinrix Junior; they were meant to receive Twinrix Junior adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 7-year-old male patient who received HAB (Twinrix) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   Previously administered products included Hepatitis A (received 2 doses of hepatitis a on an unknown date.) and Hepatitis B (received 5 doses of hepatitis b on an unknown date.).   On 29-NOV-2023, the patient received Twinrix. On 29-NOV-2023, an unknown time after receiving Twinrix, the patient experienced adult product administered to child (Verbatim: they were meant to receive Twinrix Junior adult) and overdose (Verbatim: they were meant to receive Twinrix Junior). The outcome of the adult product administered to child and overdose were unknown.   This report is made by RA without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: RA Receipt Date-29-NOV-2023 The nurse reported that the child male patient were administered a dose of Twinrix adult. The patient had previously received hepatitis A 2 doses and hepatitis B 5 doses. The nurse stated they were meant to receive Twinrix Junior, but this product was not available. this case is linked to same reporter for different patient for any tolerance please refer case US2023167168 The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023167160:1 of 2 report
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: but hasn't gotten second dose; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, received first dose over a year ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: but hasn't gotten second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 29-NOV-2023 Reporter wanted data if patient got first dose but had not gotten second dose and it had been over a year. Reporter asked a question, was there data showing it was ok to give second dose after 2 year. The reporter consented to follow up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Computerised tomogram, Headache, Pain in extremity, Sinusitis
Clinical narrative: Sinus infection; Headache; Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2X7NA, expiry date 23-MAR-2025) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia. Concomitant products included zanubrutinib.   On 23-OCT-2023, the patient received Arexvy (intramuscular). On 24-OCT-2023, 1 days after receiving Arexvy, the patient experienced pain in arm (Verbatim: Sore arm). On 25-OCT-2023, the patient experienced headache (Verbatim: Headache). On an unknown date, the patient experienced sinus infection (Verbatim: Sinus infection). The patient was treated with amoxicillin trihydrate, clavulanate potassium (Augmentin) and cefuroxime axetil (Ceftin). On 28-OCT-2023, the outcome of the pain in arm was resolved. The outcome of the headache was not resolved and the outcome of the sinus infection was not reported.   It was unknown if the reporter considered the headache, pain in arm and sinus infection to be related to Arexvy.     It was unknown if the company considered the headache, pain in arm and sinus infection to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-NOV-2023 The patient received Arexvy vaccine and for few days she experienced sore arm. After 48 hours of vaccination, she began having a headache which has not yet stopped. She took Zanubrutinib as concomitant for chronic lymphocytic leukemia. For one week she held the Zanubrutinib to see if it was the culprit, but the headache continued, so she resumed Zanubrutinib. She also reported that she has been battling a sinus infection. She has been treated with Augmentin and Ceftin for sinus infection. She has seen multiple doctors (4 doctors, 2 PAs, 1 dentist and 1 optometrist). She had multiple tests including a CT scan.  There was no diagnosis.  She was scheduled for an MRI next week and a neurology consult in January of 2024.  The patient required (Emergency room) ER Visit.  The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: hot at injection site; Bumpy rash; itching; Big red rash; Tiredness; Low fever; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24-NOV-2023, the patient received the 1st dose of Shingrix. In NOV-2023, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: hot at injection site), papular rash (Verbatim: Bumpy rash), pruritus (Verbatim: itching), red rash (Verbatim: Big red rash), tiredness (Verbatim: Tiredness), fever (Verbatim: Low fever) and chills (Verbatim: Chills). The outcome of the injection site warmth, tiredness, fever and chills were unknown and the outcome of the papular rash was resolved and the outcome of the pruritus and red rash were not resolved.   It was unknown if the reporter considered the injection site warmth, papular rash, pruritus, red rash, tiredness, fever and chills to be related to Shingrix.     It was unknown if the company considered the injection site warmth, papular rash, pruritus, red rash, tiredness, fever and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-Nov-2023 The patient was self-reported this case. The patient received Shingrix vaccine and experienced chills, low fever, tiredness, big red rash, bumpy rash, hot at the injection site and itching. Patient reported that the bumps had resolved but the rash and the itching have not resolved.  The patient reported that the person that injected the vaccine squeezed the injection site for more than a minute before administering the vaccine.  The reporter stated that she was a nurse and this was not a known practice. The reporter did not consent to follow up.