chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, FLU3, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received three vaccines on 11-15-24. We noticed after the fact that the pneumovax 23 was expired. It had an expiration date of 08-25-24. Patient has not report any adverse event at this time.  Patient will be advise to come in for a re-dose.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness with swelling, heat and mild pain
Age: 64.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: patient was fine the day of the shot (10/25/2024) when she woke up on 10/16/24 she felt really faint and her blood pressure was 80/something which was very low for her. She had a teaspoon of honey and drank a lot of water and her blood pressure came back up to normal after an hour.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Diarrhoea, Dyschezia, Frequent bowel movements, Grunting, Irritability
Clinical narrative: Large watery bowel movement on 11/6/2024, diarrhea stool started on 11/7/2024.  Stools were 7-8 times per day when it started. He was more clingy and less playful, did not sleep well on day 2-3, eating well. He is back to normal. Yesterday  (11/12/2024) at 5 stools per day. He is grunting and straining with stooling with small volume. No blood or mucus. No fever, cough, congestion, vomiting.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Poor quality sleep, Stool analysis normal
Clinical narrative: Large watery bowel movement on 11/6/2024, diarrhea stool started on 11/7/2024.  Stools were 7-8 times per day when it started. He was more clingy and less playful, did not sleep well on day 2-3, eating well. He is back to normal. Yesterday  (11/12/2024) at 5 stools per day. He is grunting and straining with stooling with small volume. No blood or mucus. No fever, cough, congestion, vomiting.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Patient became dizzy after the vaccination. She sat down and then fainted. Patient states that it was the sight of blood and not the immunization that bothered her.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: PATIENT GOT VACCINE, HAS HAD FLU SHOTS IN THE PAST.  PT WAS THE FIRST OF SIBLINGS TO GET SHOTS.  SHE DID FINE, BUT THEN WHEN SAW SISTER GET SHOT A FEW MINUTES AFTER HERSELF, SHE PASSED OUT.  SHE LEANED ON HER MOM, AND DID NOT RECEIVE ANY INJURIES....SHE WOKE BACK UP AND WAS FINE WITH NO RESIDUAL SIDE EFFECTS. MOM WAS INFORMED TO LET US KNOW IF ANY ISSUES THAT MAY COME UP...
Age: 16.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Flu vaccine given instead of the covid .vaccine . Reported to Mother, Provider and Nurse Manager . No symptoms or signs. no adverse event .
Age: 60.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Asthma, Dyspnoea, Fear, Incomplete course of vaccination, Respiratory disorder
Clinical narrative: 2-3 hours later I couldn?t breathe well and I was extremely scared, I was minutes away from calling 911 firefighters ??. Since then I?ve had breathing issues exasperated because of the reaction to the vaccines. I?ve had flu shots and Covid shots since but I?ve never had the second 2# booster shot for the shingles. Due to my age and medication, please ensure that no one is given two vaccines at the same time. Curious what the ingredients of shingles 2  dose vaccine are and how it differs from the newer ones. I?m curious to know which rsv vaccine would be recommended based on ingredients that I?ve reacted to vs two types of RSV vaccine/ pneumonia vaccine etc. thanks
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Ear discomfort, Impaired work ability, Nasal congestion
Clinical narrative: Felt okay after initial shot, then later that night starting getting chills, body aches, and shaking. Next day woke up with slight fever (100.1°F), body aches, fatigue, and stuffy nose. Was unable to go to work. Next day the fever and body aches were improved, but head cold developed. Stuffy nose, dry mouth, sinus pressure, full ears, and occasional sneezing. Head cold continued for 3 more days, getting slightly better each day.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Paranasal sinus discomfort, Sneezing, Tremor
Clinical narrative: Felt okay after initial shot, then later that night starting getting chills, body aches, and shaking. Next day woke up with slight fever (100.1°F), body aches, fatigue, and stuffy nose. Was unable to go to work. Next day the fever and body aches were improved, but head cold developed. Stuffy nose, dry mouth, sinus pressure, full ears, and occasional sneezing. Head cold continued for 3 more days, getting slightly better each day.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discharge
Clinical narrative: Patient alleged that her vaccination was given subcutaneously instead of into the muscle.  The pharmacist on duty verified that the correct vaccination and needle 25G 1 inch was used. She also reviewed the area of injection which was the left deltoid. The pharmacy manager also reviewed the area of injection and spoke to the patient about her complaint. Based on the information we received it seems that she believes that she received a subcutaneous vaccination because the vaccination did not hurt like previous vaccinations and a tiny drip of liquid came out of the area of injection. Based on the assessment of both pharmacists and the location of her bandage, we believe her vaccination was given correctly, intramuscularly into the left deltoid. We did not revaccinate the patient.
Age: 25.0
Sex: F
Vaccine: FLUN3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reports experiencing numbness and tingling in both arms while driving home after the vaccination. She called EMS and was taken to the ER. This was reported to me via phone call from patient's mother while they were waiting  for triage in the ER. Outcome is unknown to me.
Age: 24.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Mobility decreased, Swelling
Clinical narrative: Received vaccine on 10/8. Shoulder pain got worse throughout the next week, making it difficult to lift my arm above shoulder. Then I took ibuprofen for two days to try and calm down swelling. It got better, and then worsened again. Then I had a doctors appointment on November 1st to discuss treatment. They had me take Naproxen twice daily for a week. Things improved, but as soon as I got off the naproxen, it worsened again. I still have my receipts from the original pharmacy vaccination appointment if you need that info.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received twice this year. Patient already received Fluad on 7/29/24 and then again on 11/13/24
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received a high dose flu vaccine but was supposed to get a regular flu vaccine. No issues reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Cardiac flutter, Chest pain
Clinical narrative: 15 min after vaccine Heart palpitation, hunger, arm pain, light headed, dizzy, stomach pain, jitters. 20 min after sore throat, itchy legs, cold and chills, blurry vision, muted hearing, dulled senses. 15 hrs stabbing in chest, fluttering in chest, sharp pain in chest when lifting arm. next day light headed, dizzy, rash on face, watery eyes, chest pain, back pain, head pain, congestion, could not stand without assistance. Lasted for 4 days. Resolved on its own after a week
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Feeling cold, Feeling jittery, Headache
Clinical narrative: 15 min after vaccine Heart palpitation, hunger, arm pain, light headed, dizzy, stomach pain, jitters. 20 min after sore throat, itchy legs, cold and chills, blurry vision, muted hearing, dulled senses. 15 hrs stabbing in chest, fluttering in chest, sharp pain in chest when lifting arm. next day light headed, dizzy, rash on face, watery eyes, chest pain, back pain, head pain, congestion, could not stand without assistance. Lasted for 4 days. Resolved on its own after a week
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoacusis, Lacrimation increased, Oropharyngeal pain, Pain, Palpitations
Clinical narrative: 15 min after vaccine Heart palpitation, hunger, arm pain, light headed, dizzy, stomach pain, jitters. 20 min after sore throat, itchy legs, cold and chills, blurry vision, muted hearing, dulled senses. 15 hrs stabbing in chest, fluttering in chest, sharp pain in chest when lifting arm. next day light headed, dizzy, rash on face, watery eyes, chest pain, back pain, head pain, congestion, could not stand without assistance. Lasted for 4 days. Resolved on its own after a week
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Respiratory tract congestion, Vision blurred
Clinical narrative: 15 min after vaccine Heart palpitation, hunger, arm pain, light headed, dizzy, stomach pain, jitters. 20 min after sore throat, itchy legs, cold and chills, blurry vision, muted hearing, dulled senses. 15 hrs stabbing in chest, fluttering in chest, sharp pain in chest when lifting arm. next day light headed, dizzy, rash on face, watery eyes, chest pain, back pain, head pain, congestion, could not stand without assistance. Lasted for 4 days. Resolved on its own after a week
Age: 65.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Arthralgia, Pain
Clinical narrative: Patient came by to tell us that after she received her vaccinations she has had radiating  pain from her shoulder.  Anytime she moves her arm and it involves her shoulder it hurts.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Fatigue, Hypersomnia
Clinical narrative: Diarrhea severe, severe fatigue. Sleeping alot
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthropod bite, Deep vein thrombosis, Impaired healing, Peripheral swelling
Clinical narrative: On  the morning of 10/29/2024 I noted an ache in the back of my right knee.  After walking on it for a few hours the ache became much worse.  I'm a traveling Nurse, working in Surgery.  I asked a General surgeon if he could take a look at me leg.  The leg was swollen and previous wounds from some bug bites had not been healing.  The Drs initial impression was a DVT.  He ordered an Ultrasound / Doppler which subsequently showed a Blood clot extending from my Right groin down to my Right Knee.  The Hospital I'm at during this event could not handle the procedure required to address the blood clot.  I had to drive 1 1/2 hr south of my current location to have it evaluated and treated.  It took 2 procdures in the cath lab to get all the clot out.  The 1st procedure could only get out 80% of the clot. The surgeon ordered for me to receive TPA over night and bring me back to the cath lab the next day.  The 2nd procedure was able to remove the remaining 20% of the clot, after the TPA treatment. As I type this I am 3 wks post op.  A follow up ultrasound at 2 wks post op showed continued clot in my lower right leg and clot extending up above my right knee.  Which means the original clot was not all removed, or the clot as returned. I am now on Eloquis 5 mg BID for the foreseeable future.   As a 57 yr old, with NO family hx of blood clots, and no personal hx of blood clots it makes me wonder whether the Covid Vaccine I received was an influencing factor in my developing such a massive blood clot, and blood clots that continue to plague me.  My experience with my previous 4 Covid vaccines were unremarkable, up until this most recent vaccination.  I did not find out until after this event happened that there has been increased incidence of Blood clot formation shortly after Covid vaccination.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombectomy, Ultrasound Doppler abnormal
Clinical narrative: On  the morning of 10/29/2024 I noted an ache in the back of my right knee.  After walking on it for a few hours the ache became much worse.  I'm a traveling Nurse, working in Surgery.  I asked a General surgeon if he could take a look at me leg.  The leg was swollen and previous wounds from some bug bites had not been healing.  The Drs initial impression was a DVT.  He ordered an Ultrasound / Doppler which subsequently showed a Blood clot extending from my Right groin down to my Right Knee.  The Hospital I'm at during this event could not handle the procedure required to address the blood clot.  I had to drive 1 1/2 hr south of my current location to have it evaluated and treated.  It took 2 procdures in the cath lab to get all the clot out.  The 1st procedure could only get out 80% of the clot. The surgeon ordered for me to receive TPA over night and bring me back to the cath lab the next day.  The 2nd procedure was able to remove the remaining 20% of the clot, after the TPA treatment. As I type this I am 3 wks post op.  A follow up ultrasound at 2 wks post op showed continued clot in my lower right leg and clot extending up above my right knee.  Which means the original clot was not all removed, or the clot as returned. I am now on Eloquis 5 mg BID for the foreseeable future.   As a 57 yr old, with NO family hx of blood clots, and no personal hx of blood clots it makes me wonder whether the Covid Vaccine I received was an influencing factor in my developing such a massive blood clot, and blood clots that continue to plague me.  My experience with my previous 4 Covid vaccines were unremarkable, up until this most recent vaccination.  I did not find out until after this event happened that there has been increased incidence of Blood clot formation shortly after Covid vaccination.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient already received Fluad on 7/29/24 and received again on 11/13/24
Age: 18.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Nurse calling to report inadvertently administering a second dose of VARIVAX vaccine prior to minimum 4-week interval. Caller stated first dose was administered on 9/23/2024 and second dose was administered on 10/11/2024. Caller stated patient has no; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-SEP-2024, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot#, expiry date and route of administration were not provided). On 11-OCT-2024, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y007637, expiration date: 11-APR-2026, administered for prophylaxis (strength, dose, and route of administration were not provided). The second dose of varicella virus vaccine live (oka/merck) (VARIVAX) was administered inadvertently prior to minimum 4-week interval (Inappropriate schedule of product administration). The patient has not reported any symptom. No additional AE was reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; expired dose of MMR II was administered; This spontaneous report was received from a physician assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 12-NOV-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 ml, lot#: X005840, expiration date: 05-NOV-2024; strength was not provided) intramuscularly for prophylaxis by a health professional (expired product administered). No additional adverse events (AE) were reported (no adverse event).
Age: 0.17
Sex: U
Vaccine: PNC13, PNC15
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PREVNAR 13 vaccine at ages 2 months, 4 months and 6 months/her child received the VAXNEUVANCE vaccine at 12 months of age to complete the vaccination series as the fourth dose; No additional AE; This spontaneous report was received from consumer and refers to a 12-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with 1st, 2nd, 3rd dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) at ages 2 months, 4 months and 6 months (strength, formulation, dose, lot #, expiry date,  anatomical site of administration and route of administration were not provided); and with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, complete the vaccination series as the fourth dose at 12 months of age, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) (Product administered to patient of inappropriate age), patient's mother had no further clarifications to provide. No additional adverse event (AE).  Additional Information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: near Killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: near Killed me) (serious criteria GSK medically significant). The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.     The company considered the near death experience to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-NOV-2024 This case was reported by a patient via interactive digital media. The patient said if we have had Shingles as he/she did had years ago and then a doctor told him/her that needed the new updated shot and it near killed the patient.; Sender's Comments: Near death experience is an unlisted event  which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blister, Herpes zoster, Lymphadenopathy, Pain, Pruritus
Clinical narrative: Shingles; lymph node enlargement; Pain; itchy/sore area by my left axilla that developed into vesicles; itchy; This non-serious case was reported by a consumer and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number G2XE5, expiry date 10-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included diabetes. Concomitant products included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall), rabeprazole sodium (Aciphex), bupropion hydrochloride (Wellbutrin), alprazolam (Xanax) and benzylpenicillin potassium (Pen).   On 29-AUG-2024, the patient received Shingrix (left arm) .5 ml and Tdap Vaccine (left arm). On 30-AUG-2024, 1 days after receiving Shingrix and Tdap Vaccine, the patient experienced shingles (Verbatim: Shingles), enlargement of lymph nodes (Verbatim: lymph node enlargement), pain (Verbatim: Pain), vesicles (Verbatim: itchy/sore area by my left axilla that developed into vesicles) and pruritus (Verbatim: itchy). The patient was treated with aciclovir sodium (Zovirax). On 12-SEP-2024, the outcome of the shingles was resolved. The outcome of the enlargement of lymph nodes, pain, vesicles and pruritus were not reported.   It was unknown if the reporter considered the shingles, enlargement of lymph nodes, pain, vesicles and pruritus to be related to Shingrix and Tdap Vaccine.     It was unknown if the company considered the shingles, enlargement of lymph nodes, pain, vesicles and pruritus to be related to Shingrix and Tdap Vaccine.   Additional Information: GSK Receipt Date: 16-OCT-2024 The case was self reported by patient. The patient received TDaP and the Shingrix vaccine both in the left arm. The patient had lymph node enlargement and pain, and an itchy/sore area by the left axilla that developed into vesicles. The patient had a virtual appointment with a physician through which provided pictures, and they diagnosed this as shingles and started Zovirax. The patient had blood work pending to see if patient was diabetic, other than that, patient was overweight, but in good health.  Also had chickenpox once, before first birthday.
Sex: U
Vaccine: RSV
Symptoms: Incorrect route of product administration
Clinical narrative: Arexvy was administered subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a specified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-OCT-2024, the patients received Arexvy (subcutaneous). On 15-OCT-2024, an unknown time after receiving Arexvy, the patients experienced intramuscular formulation administered by other route (Verbatim: Arexvy was administered subcutaneously). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 16-OCT-2024 The reporter reported that the Arexvy vaccine was administered subcutaneously to 3 patient yesterday (Day before reporting) which led to, intramuscular formulation administered by other route. The vaccine administration facility was the same as primary reporter. The reporter did not had patient details at the time of the call, nor did had lot numbers. The reporter stated she could get them.
Sex: F
Vaccine: RVX
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: impaired her ability to play tennis; Soreness in arm for 1 week; This non-serious case was reported by a physician via sales rep and described the occurrence of pain in arm in a elderly female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine (unknown arm). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Soreness in arm for 1 week) and activities of daily living impaired (Verbatim: impaired her ability to play tennis). The outcome of the pain in arm was resolved (duration 1 week) and the outcome of the activities of daily living impaired was resolved.   The reporter considered the pain in arm and activities of daily living impaired to be related to RSV vaccine.     The company considered the pain in arm and activities of daily living impaired to be related to RSV vaccine.   Additional Information: GSK receipt date: 17-OCT-2024 Reporter reported that the patient received the first dose of RSV vaccination and unknown which vaccine had received.  Patient experienced Soreness in arm for 1 week and also indicated that the arm soreness impaired her ability to play tennis. Reporter was having a conversation with a researcher at the conference and one of their Healthcare Professional colleagues came up and started mentioning their own Adverse Events related to RSV vaccination and product was not known. Reporter did not know the person who experienced the Adverse Events.
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Contraindicated product administered, Exposure during pregnancy, Wrong product administered
Clinical narrative: was given arexvy instead of abrysvo; was given arexvy instead of abrysvo to pregnant women; was given arexvy instead of abrysvo to pregnant women; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered in a 29-year-old female 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 wrong vaccine administered (Verbatim: was given arexvy instead of abrysvo), contraindicated drug administered (Verbatim: was given arexvy instead of abrysvo to pregnant women) and vaccine exposure during pregnancy (Verbatim: was given arexvy instead of abrysvo to pregnant women). The outcome of the wrong vaccine administered, contraindicated drug administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 37 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 14-OCT-2024 The patient was 29 years female, coming upto 37 weeks pregnant. The patient had received RSV vaccine, and noted when she looked on the immunisation paper that she was given Arexvy, instead of Abrysvo which led to wrong vaccine administered, contraindicated drug administered and vaccine exposure during pregnancy. The patient was concerned as Arexvy was not approved for pregnant women. Was there anything she should do or anything she need to be worried about.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult patient received the child dose of Engerix B; adult patient received the child dose of Engerix B; 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 patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: adult patient received the child dose of Engerix B) and underdose (Verbatim: adult patient received the child dose of Engerix B). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2024 The reporter had an instance where an adult patient received the child dose of Engerix B (dose 2) which led to adult use of a child product and underdose. The reporter questioned would the patient complete the series with the adult dose and get titers.
Sex: U
Vaccine: RSV
Symptoms: Cough
Clinical narrative: flimy cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough 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 cough (Verbatim: flimy cough). The outcome of the cough was not reported.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-OCT-2024 This case was reported by a patient via interactive digital media. The patient had filmy cough after receiving Arexvy vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Injection site pruritus
Clinical narrative: The location of the injection still itches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than 2 weeks after receiving Arexvy, the patient experienced injection site itching (Verbatim: The location of the injection still itches). The outcome of the injection site itching was not resolved.   It was unknown if the reporter considered the injection site itching to be related to Arexvy.     It was unknown if the company considered the injection site itching to be related to Arexvy.   Additional Information: GSK receipt date: 17-OCT-2024 Consumer reported that the location of the injection was still itches 13 days after receiving the vaccine. The follow-up could not be possible as no contact details were available.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Accidental underdose; This non-serious case was reported by a other health professional and described the occurrence of accidental underdose in a 14-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 3363M) for prophylaxis.   On 17-SEP-2024, the patient received the 1st dose of FluLaval 2024-2025 season (intramuscular, right deltoid) .5 ml. On 17-SEP-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental underdose (Verbatim: Accidental underdose). The outcome of the accidental underdose 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: Update narrative : GSK receipt date: 16-OCT-2024 Other healthcare professional reported that a patient received FluLaval Trivalent 2024-2025 season. The vaccine shot out the side of the Luer lock, presumably from a crack in the lock. At this point he/she had been assembling the vaccines and checking the seal carefully multiple times leading up to injection. At no point during assembly did the reporter hear/feel/see the Luer lock crack. There were no signs something was wrong with the vaccine until they administered it.  The vaccines were very temperamental, and we walk a very fine line between the needle not being screwed on tight enough and being for tight. The same vaccine was leaked during administration to the patient, which led to accidental underdose.; Sender's Comments:  US-GSK-US2024AMR128465: US-GSK-US2024AMR114494: US-GSK-US2024AMR128469:
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Accidental underdose; This non-serious case was reported by a other health professional and described the occurrence of accidental underdose in a 39-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 3363M) for prophylaxis.   On 20-SEP-2024, the patient received FluLaval 2024-2025 season (intramuscular) .5 ml. On 20-SEP-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental underdose (Verbatim: Accidental underdose). The outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-OCT-2024 MA (medical assistant) reported that assembled and administered Flulaval vaccine appropriately and checked seal during assembly. However, upon administration much of the vaccine leaked out the side instead of going into the patient, which led to an accidental underdose. As per MD (doctor of medicine), MA prepped new vaccine and re-administered without issue. Patient received hypodermic needle-pro edge safety device 256 x 5/8 in, as concomitant. This was 1 of 4 linked case, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR114494: US-GSK-US2024AMR128468: US-GSK-US2024AMR128465:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Shoulder operation, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have shingles currently; itching was intense til I got on medicine for it; just some stabbing pain every now; shoulder surgery; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In OCT-2024, an unknown time after receiving Shingles vaccine, the patient experienced shoulder operation (Verbatim: shoulder surgery) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have shingles currently), pruritus (Verbatim: itching was intense til I got on medicine for it) and pain (Verbatim: just some stabbing pain every now). The outcome of the vaccination failure, shoulder operation and pruritus were not reported and the outcome of the shingles and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shoulder operation, shingles, pruritus and pain to be related to Shingles vaccine.     The company considered the vaccination failure and shoulder operation to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, pruritus and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-NOV-2024 This case was reported by a patient via interactive digital media. The reporter reported that a patient had shingles currently after just having shoulder surgery two weeks ago and had the vaccine but it must help because it was no severe, just come stabbing pain every now and then but the itching was intense till got the medicine for it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles) is considered unrelated to GSK vaccine Shingles vaccine.  Shoulder operation is an unlisted events which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: most painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In SEP-2019, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: most painful). The outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2024 The patient was the reporter. The patient had the first dose of Shingrix in July of 2019, and the second in September of 2019. The patient stated it was the most painful shot he ever had. It was unclear if the patient was referring to the first, second or both doses of Shingrix. Date of birth was not collected.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: dose of the 2 vial formulation of Menveo was reconstituted with regular sterile water instead of the supplied CYW-135 component; dose of the 2 vial formulation of Menveo was reconstituted with regular sterile water instead of the supplied CYW-135 component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis.   On 10-OCT-2024, the patient received Menveo. On 10-OCT-2024, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: dose of the 2 vial formulation of Menveo was reconstituted with regular sterile water instead of the supplied CYW-135 component) and wrong solution used in drug reconstitution (Verbatim: dose of the 2 vial formulation of Menveo was reconstituted with regular sterile water instead of the supplied CYW-135 component). The outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.   Additional Information: GSK receipt date: 16-OCT-2024 The medical assistant reported a dose of the 2-vial formulation of Menveo was reconstituted with regular sterile water instead of the supplied CYW-135 component which led to, inappropriate dose of vaccine administered, and wrong solution used in drug reconstitution. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix, patient has 6th Dtaps; accidentally received a dose of Infanrix instead of BOOSTRIX as intended; 11 year old pateint received Infanrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Infanrix (received 5 doses on an unknown date).   On 09-OCT-2024, the patient received the 6th dose of Infanrix. On an unknown date, the patient did not receive Boostrix. On 09-OCT-2024, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Infanrix, patient has 6th Dtaps), wrong vaccine administered (Verbatim: accidentally received a dose of Infanrix instead of BOOSTRIX as intended) and inappropriate age at vaccine administration (Verbatim: 11 year old pateint received Infanrix vaccine). The outcome of the extra dose administered, wrong vaccine administered and inappropriate age at vaccine administration 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: 16-OCT-2024 The reporter reported that the patient received the accidentally received a dose of Infanrix instead of Boostrix as intended which led to wrong vaccine administered and inappropriate age at vaccine administration. This was the patient 6th Dtaps which led to extra dose administered.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix plus adjuvant only administered; Shingrix plus adjuvant only 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 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 9595Y, expiry date 27-OCT-2026) for prophylaxis.   On 17-OCT-2024, the patient received Shingrix. On 17-OCT-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix plus adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix plus adjuvant only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-OCT-2024 Medical assistant called to report the adjuvant suspension of Shingrix was administered without the lyophilized component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: FLU4
Symptoms: Intercepted product administration error
Clinical narrative: explained that last year's Fluarix (2023-2024) should be expired; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted product administration error in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2024-2025 season) for prophylaxis.   On an unknown date, the patient did not receive Fluarix Quadrivalent 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2024-2025 season, the patient experienced intercepted product administration error (Verbatim: explained that last year's Fluarix (2023-2024) should be expired). The outcome of the intercepted product administration error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-OCT-2024 The patient self-reported this case for himself. The reporter did not want an adverse event reported.  The reporter was explained that last year's Fluarix (2023-2024) was quadrivalent but the reporting year's Fluarix (2024-2025) was trivalent.  The reporter explained that last year's Fluarix (2023-2024) should be expired.  The reporter indicated that he recently went into a pharmacy and asked for a flu shot.  The reporter reported that they were repreparing the shot and were going to inject him but he asked to look at the syringe.  The syringe said "Fluarix Quadrivalent."  The patient declined the shot because he knew that the Centers for Disease Control and Prevention was recommending the trivalent this season which led to intercepted product administration error.  No further questions were asked.the reporter wanted to end the call.
Sex: M
Vaccine: RSV
Symptoms: Incorrect route of product administration, Injection site mass
Clinical narrative: lump developed on left arm; administer Arexvy by intercostal route; This non-serious case was reported by a physician via call center representative and described the occurrence of mass in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Arexvy (intercostal, left arm) .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced mass (Verbatim: lump developed on left arm) and intramuscular formulation administered by other route (Verbatim: administer Arexvy by intercostal route). The outcome of the mass and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the mass to be related to Arexvy.     It was unknown if the company considered the mass to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-OCT-2024 The physician reported that the patient who was the health care professional received RSV vaccine in the same arm that he previously had cancer located. The age of the patient was 75 years and older. No identifying information was given about RSV vaccine, however, the patient states that the vaccine was Arexvy. After receiving the RSV vaccine a lump developed on left arm, (Symptomatic). Patient made a statement to the field representative saying he thinks the vaccine awakened the cancer and he was going to get a biopsy. The Arexvy vaccine was administered by intercostal route, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: RSV
Symptoms: Intercepted product prescribing error
Clinical narrative: prescribed a second dose of Arexvy to a 71 year old patient/not administered the dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 71-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose a year ago, on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: prescribed a second dose of Arexvy to a 71 year old patient/not administered the dose). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 23-OCT-2024 The pharmacist reported that the physician prescribed a second dose of Arexvy to the patient without any specific reason. At the time of the call, the pharmacist had not administered the dose, which led to intercepted drug prescribing error.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: administration of a second dose of Arexvy to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X4EA5, expiry date 16-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received first dose of Arexvy on 4th December 2023).   On 31-OCT-2024, the patient received the 2nd dose of Arexvy. On 31-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: administration of a second dose of Arexvy to a patient). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2024  The pharmacist reported the administration of a second dose of Arexvy to a patient.  The patient first dose was given and second dose was given on the day of reporting which led to extra dose administered.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: and then received 2nd dose; Co-suspect products included  .   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).     On 24-MAY-2019, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim:  and then received 2nd dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2024 The pharmacist reported that he/she had a patient who was requesting a 3rd dose of Shingrix, and the reason was that her first two doses were least that 8 weeks apart, that she got on her provider office. The patient was telling that she needed an extra dose and the pharmacist could find any information to support that the patient got the 1st one and then 2nd one which led to drug dose administration interval too short. The reporter missed to report the adverse event in the appropriate time, that why the patient was reporting the adverse event on the day of reporting, however, the healthcare professional originally called, during the call, the healthcare professional mentioned that the patient received the 1st Shingrix dose and then the 2nd dose, within 6 weeks apart, that why the patient was requesting a 3rd dose also.