chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported that a dose of VARIVAX was administered to a patient after a temperature excursion. Caller stated the dose was administered on 10/26/2023 and the product had 3 temperature excursion prior being administered. Caller stated pa; This spontaneous report was received from a nurse and refers to a patient of unknown ae and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W031810, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before admission to a patient in 6 Farenheit for 35 minutes (Product storage error). Previous excursion also occured in 14 degree Farenheit for 1 hour 29 minutes and in 6 degree Farenheit to 14 degree Farenheit fo 1 hours 15 minutes. No additional adverse events were reported.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Rash that appeared about 5 weeks post vaccine. It was not itchy or blistering, just a raised pink rash allover my neck and torso. My PMD said it looked like a reaction to the RSV vaccine.
Age: 52.0
Sex: F
Vaccine: FLUR4, PNC20, TDAP, VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: no reported adverse events- vaccine administration error- Shingrix adjuvent only injected, no active antigen
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: deltoid vaccine injection noticed 12hrs after injection, redness, swelling, warmth, closer to elbow than deltoid, no systemic symptoms, local reaction only
Age: 31.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: Immunization Administration Error: Pt. was given a Dtap instead of a Tdap. No adverse reaction occured.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Electronystagmogram, Vertigo, Vertigo positional
Clinical narrative: Within a week I had vertigo on the right side.  Then both sides, then looking up and down. Going to Clinic for PT.   I had the exact same experience in 2022 after the booster. The vertigo lasted 4 months and was much worse than this years.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Ecchymosis, Epistaxis, Haemorrhage, Immune thrombocytopenia, Immunoglobulin therapy
Clinical narrative: Patient is a 76 y.o. is a 76 y.o. gentleman with profound thrombocytopenia of unclear etiology but presumed to be ITP perhaps due to recent RSV vaccination. He has been refractory to corticosteroids as well as IVIG 1g/kg daily x2 given in conjunction with corticosteroids. He has been having ongoing ecchymoses and bleeding (epistaxis). He has now received romiplostim 1mcg/kg on 11/14.  Lack of response so far on platelets. Ongoing mild bleeds on and off  Would have next dose be increased to 3 mcg/kg instead of 2.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Platelet count decreased, Therapy non-responder, Thrombocytopenia
Clinical narrative: Patient is a 76 y.o. is a 76 y.o. gentleman with profound thrombocytopenia of unclear etiology but presumed to be ITP perhaps due to recent RSV vaccination. He has been refractory to corticosteroids as well as IVIG 1g/kg daily x2 given in conjunction with corticosteroids. He has been having ongoing ecchymoses and bleeding (epistaxis). He has now received romiplostim 1mcg/kg on 11/14.  Lack of response so far on platelets. Ongoing mild bleeds on and off  Would have next dose be increased to 3 mcg/kg instead of 2.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Conjunctivitis, Dysphonia, Eye disorder, Eye swelling
Clinical narrative: She got her vaccine, made sure to sit there and talk for a few minutes about 10 minutes.  She felt a little bit strange and did not think much about it.  She started driving and went to the grocery store with a friend, and the next thing she knew they got into the grocery store and felt bad, a little wobbly.  They were on their way back to the house and it was like she had gauze in front of her eyes, not able to see.  She was sitting there stating that her eyes were doing something funny and they needed to get back to the house.  Her friend told her that her eyes were swelling.  Her friend went to get the Epi-Pen as she knew she was having an allergic reaction.  She waited and got an ice pack and put it on her eyes, which helped.  She got to sleep that night and when she woke up around 3:00 AM she was having a lot of problems.  Her eyes were so swollen that her right eye was swollen shut.  She also realized that her nasal cavity was swollen almost shut, and her throat felt like somebody had taken a wire brush and gone and down in her throat.  She had no itching like she has when she has had other reactions.  It was just the burning sensation in her throat and her eyes.  The right eye was totally closed and it was humongous.  She let it take it's course, was real careful and can barely talk as she has lost her voice.  There was 2 days that she did not say anything to anybody, did not drive, could see partially out of her left eye and run her hand down the wall to see where she was going.   She did not have to use the Epi-pen.  Today her eye is much better, open some and bright red when she looked on it, the left one was like pink eye and she did have conjunctivitis in it.  She did not call her doctor as it was the weekend, and they would not have been open and they would tell her to go to the hospital and she knew what to do from prior experience and she could use the Epi-pen and roommate could call 911.    She is better today, her eye on the right side is not fully opened, but it is not like a softball anymore, but she is able to see out of it.  Her throat is still feeling scratchy and sounds scratchy and is having to drink water and getting more irritated.    Has had all her previous COVID vaccines and had never had a reaction.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Hypersensitivity, Impaired driving ability, Nasal oedema
Clinical narrative: She got her vaccine, made sure to sit there and talk for a few minutes about 10 minutes.  She felt a little bit strange and did not think much about it.  She started driving and went to the grocery store with a friend, and the next thing she knew they got into the grocery store and felt bad, a little wobbly.  They were on their way back to the house and it was like she had gauze in front of her eyes, not able to see.  She was sitting there stating that her eyes were doing something funny and they needed to get back to the house.  Her friend told her that her eyes were swelling.  Her friend went to get the Epi-Pen as she knew she was having an allergic reaction.  She waited and got an ice pack and put it on her eyes, which helped.  She got to sleep that night and when she woke up around 3:00 AM she was having a lot of problems.  Her eyes were so swollen that her right eye was swollen shut.  She also realized that her nasal cavity was swollen almost shut, and her throat felt like somebody had taken a wire brush and gone and down in her throat.  She had no itching like she has when she has had other reactions.  It was just the burning sensation in her throat and her eyes.  The right eye was totally closed and it was humongous.  She let it take it's course, was real careful and can barely talk as she has lost her voice.  There was 2 days that she did not say anything to anybody, did not drive, could see partially out of her left eye and run her hand down the wall to see where she was going.   She did not have to use the Epi-pen.  Today her eye is much better, open some and bright red when she looked on it, the left one was like pink eye and she did have conjunctivitis in it.  She did not call her doctor as it was the weekend, and they would not have been open and they would tell her to go to the hospital and she knew what to do from prior experience and she could use the Epi-pen and roommate could call 911.    She is better today, her eye on the right side is not fully opened, but it is not like a softball anymore, but she is able to see out of it.  Her throat is still feeling scratchy and sounds scratchy and is having to drink water and getting more irritated.    Has had all her previous COVID vaccines and had never had a reaction.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Sleep disorder, Throat irritation, Visual impairment
Clinical narrative: She got her vaccine, made sure to sit there and talk for a few minutes about 10 minutes.  She felt a little bit strange and did not think much about it.  She started driving and went to the grocery store with a friend, and the next thing she knew they got into the grocery store and felt bad, a little wobbly.  They were on their way back to the house and it was like she had gauze in front of her eyes, not able to see.  She was sitting there stating that her eyes were doing something funny and they needed to get back to the house.  Her friend told her that her eyes were swelling.  Her friend went to get the Epi-Pen as she knew she was having an allergic reaction.  She waited and got an ice pack and put it on her eyes, which helped.  She got to sleep that night and when she woke up around 3:00 AM she was having a lot of problems.  Her eyes were so swollen that her right eye was swollen shut.  She also realized that her nasal cavity was swollen almost shut, and her throat felt like somebody had taken a wire brush and gone and down in her throat.  She had no itching like she has when she has had other reactions.  It was just the burning sensation in her throat and her eyes.  The right eye was totally closed and it was humongous.  She let it take it's course, was real careful and can barely talk as she has lost her voice.  There was 2 days that she did not say anything to anybody, did not drive, could see partially out of her left eye and run her hand down the wall to see where she was going.   She did not have to use the Epi-pen.  Today her eye is much better, open some and bright red when she looked on it, the left one was like pink eye and she did have conjunctivitis in it.  She did not call her doctor as it was the weekend, and they would not have been open and they would tell her to go to the hospital and she knew what to do from prior experience and she could use the Epi-pen and roommate could call 911.    She is better today, her eye on the right side is not fully opened, but it is not like a softball anymore, but she is able to see out of it.  Her throat is still feeling scratchy and sounds scratchy and is having to drink water and getting more irritated.    Has had all her previous COVID vaccines and had never had a reaction.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pruritus, Skin warm
Clinical narrative: redness, swelling, itchiness, tenderness, pain, warm to touch began immediately and lasted for a couple days after vaccination
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Swelling, Tenderness
Clinical narrative: redness, swelling, itchiness, tenderness, pain, warm to touch began immediately and lasted for a couple days after vaccination
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Per pt, she stated to person vaccinating that it was too high as she was applying alcohol swab on her shoulder.  Person vaccinating said it was in the right spot and proceeded to administer flu shot.  Pt states vaccination was very painful.  Pt has had to go to physical therapy since she still has pain and is unable to move/lift her arm like normal.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: higher dose than recommended for age
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea and vomiting; Chills with Fever of 102' F - Treated with PRN acetaminophen and zofran. Resident improved with Treatment.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: I'm still experiencing left arm/shoulder upper pain around the injection area.  It's been over a month since I got the flu shot.  It hurts when I lift my arm or move it around.
Age: 68.0
Sex: F
Vaccine: COVID19, FLUA4, PNC20, RSV
Symptoms: Vomiting
Clinical narrative: spontaneous vomiting.  I had no warning ahead of time.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Blindness transient, Blood glucose normal, Blood pressure decreased, Diaphragmatic hernia, Excessive eye blinking
Clinical narrative: Approximately 5 minutes after second vaccine (Menveo), patient stated "I can't see anything" from the Immunization Waiting room. Patient appeared to be pale, blinking rapidly, pupils were dilated, and she was diaphoretic. Registered nursing staff contacted to assist, and several doctors came in to evaluate patient. Patient had low blood pressure, running in the 60's/40's. Sent to ER via stretcher.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Mydriasis, Pallor
Clinical narrative: Approximately 5 minutes after second vaccine (Menveo), patient stated "I can't see anything" from the Immunization Waiting room. Patient appeared to be pale, blinking rapidly, pupils were dilated, and she was diaphoretic. Registered nursing staff contacted to assist, and several doctors came in to evaluate patient. Patient had low blood pressure, running in the 60's/40's. Sent to ER via stretcher.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Rash, Throat irritation
Clinical narrative: Rash developing with 48 hours on left side of the neck, sore / scratchy throat,  arm soreness persisting.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Muscular weakness, Nausea, Tremor
Clinical narrative: Flulaval administered 9/7/2023. 9/11/2023 patient experienced a severe migraine upon waking with arm weakness and tremors. Patient also experienced nausea from 9/11/23 to 9/13/23. Patient has not had to return for further evaluation since.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: COVID vaccine diluted incorrectly. Dose repeated based on CDC recommendation.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Condition aggravated, Dyskinesia, Infantile spasms, Laboratory test
Clinical narrative: Patient previously healthy , started having episodes of abnormal movements later recognized as infantile spasms, that mom identifies they started after receiving Vaxelis vaccine at 2-month-old.  Mother noticed that after his 2nd and 3rd dose of Vaxelis, the number of episodes intensified after the vaccination of this combination vaccine.  The infantile spasms were witnessed by a nurse 1 week after receiving his 3rd dose of Vaxelis (dose given 11/08/2023), and there was an immediate workup and admission for diagnosis and treatment for this condition.  Note that baby only received 1 type of vaccine per week per mother's preference, so she was able to identify the frequency of episodes was different when other vaccines were given.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Dizziness, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Left shoulder pain  Limited movement Left arm Right hand finger joint swelling  Dizziness  Headache
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint swelling, X-ray limb
Clinical narrative: Left shoulder pain  Limited movement Left arm Right hand finger joint swelling  Dizziness  Headache
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Pt was accidentally given the pediatric dosage of Moderna COVID-19 vaccine,  0.25ml = 25mcg. After review of CDC's, literature. Error was corrected by administering 0.25ml (25mcg) of Adult Moderna COVID -19 Vaccine on the same day so pt got a total of 0.50ml = 50mcg. Pt reports some nausea today 11/20/23 which is 4 days out from the event but otherwise tolerated without issue.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Abdominal pain upper, Cold sweat, Dizziness, Fatigue, Loss of consciousness
Clinical narrative: Pt woke up at 0400 on 11/16 with stomach ache and nausea.  Got up and went to the bathroom at 0600 with nausea, dizzyness, and cold sweats.  Pt passed out leaving the bathroom.  Woke on the floor by himself without any noted injuries.  Had 99.7 temperature, fatigue, and did not feel well all day.  Remained not feeling good on 11/7, felt better by the afternoon on 11/18.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Malaise, Nausea
Clinical narrative: Pt woke up at 0400 on 11/16 with stomach ache and nausea.  Got up and went to the bathroom at 0600 with nausea, dizzyness, and cold sweats.  Pt passed out leaving the bathroom.  Woke on the floor by himself without any noted injuries.  Had 99.7 temperature, fatigue, and did not feel well all day.  Remained not feeling good on 11/7, felt better by the afternoon on 11/18.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient was inadvertently  given MMRV instead of MMR vaccine.
Age: 17.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Blood gases, Cyanosis, Electrocardiogram, Immediate post-injection reaction, Pallor
Clinical narrative: Patient received both flu and COVID (Pfizer) vaccines by the nurse while seated in the immunization at approximately 10:30am. Soon after receiving both vaccines, the patient immediately fainted while seated and started turning pale and lips were turning purple. I was not aware of this until I was flagged by the pharmacy cashier to go into the immunization room to triage the situation. After being informed that the patient fainted, I had the patient elevate her legs. I proceeded to call 9-1-1. During the call, the patient started feeling better. I insisted that EMS take a look at the patient and let them decide if they should head to the hospital for further evaluation. EMS arrived around 10:40am and evaluate the patient. 10 minutes after evaluation, EMS reported the vitals were within normal limits, but recommended that the patient go to the hospital. The parent of the patient refused transport to the hospital. EMS left, and then after that the family left without further incident. Per the parent, this is the first time the patient has ever fainted from a vaccination. This was likely a vasovagal response. Will note this incident within patient profile.
Age: 17.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Syncope
Clinical narrative: Patient received both flu and COVID (Pfizer) vaccines by the nurse while seated in the immunization at approximately 10:30am. Soon after receiving both vaccines, the patient immediately fainted while seated and started turning pale and lips were turning purple. I was not aware of this until I was flagged by the pharmacy cashier to go into the immunization room to triage the situation. After being informed that the patient fainted, I had the patient elevate her legs. I proceeded to call 9-1-1. During the call, the patient started feeling better. I insisted that EMS take a look at the patient and let them decide if they should head to the hospital for further evaluation. EMS arrived around 10:40am and evaluate the patient. 10 minutes after evaluation, EMS reported the vitals were within normal limits, but recommended that the patient go to the hospital. The parent of the patient refused transport to the hospital. EMS left, and then after that the family left without further incident. Per the parent, this is the first time the patient has ever fainted from a vaccination. This was likely a vasovagal response. Will note this incident within patient profile.
Age: 32.0
Sex: F
Vaccine: FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLU VACCINE HIGH DOSE WAS GIVEN INSTEAD OF REGULAR DOSE  PATIENT WAS INFORMED, NO ADVERSE EFFECTS WAS REPORTED
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Pt was accidentally given the pediatric dosage of Moderna COVID-19 vaccine,  0.25ml = 25mcg. After review of CDC's, "Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates". Error was corrected by administering 0.25ml (25mcg) of Adult Moderna COVID -19 Vaccine on the same day so pt got a total of 0.5ml = 50mcg. Pt tolerated well.
Age: 60.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Injection site mass, Injection site warmth, Product administered at inappropriate site
Clinical narrative: Patient develoved 2 raised lumps on arm around injection sites. They were hot to touch but after 3 days seemed to be going away. One shot was given in rear deltoid muscle and the other was almost on back of patient's arm.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: wrong vaccine given (age 12 yo+ given to 7 yo)
Age: 70.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Peripheral swelling, Staphylococcal infection
Clinical narrative: patient said the next day she had a swollen arm and when she went to the drs office a few days later she had mrsa  from the vaccine
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Pt was accidentally given the pediatric dosage of Moderna COVID-19 vaccine,  0.25ml = 25mcg. After review of CDC's, literature. Error was corrected by administering 0.25ml (25mcg) of Adult Moderna COVID -19 Vaccine on the same day so pt got a total of 0.5ml = 50mcg
Age: 18.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLU VACCINE HIGH DOSE WAS GIVEN INSTEAD OF REGULAR DOSE  PATIENT WAS INFORMED, NO ADVERSE EFFECTS WAS REPORTED
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Pt was accidentally given the pediatric dosage of Moderna COVID-19 vaccine,  0.25ml = 25mcg. After review of CDC's, "Interim Clinical Considerations for Use of COVID-19 Vaccines: Appendices, References, and Previous Updates". Error was corrected by administering 0.25ml (25mcg) of Adult Moderna COVID -19 Vaccine on the same day so pt got a total of 0.5ml = 50mcg. Pt tolerated well.
Age: 68.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Skin exfoliation
Clinical narrative: Skin peeling off bottom of feet and toes
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatine phosphokinase increased, Blood creatinine increased, Blood potassium increased, Blood urea increased
Clinical narrative: Patient could not ambulate for entire 2 days after vaccination and had to be lying down on the floor unable to get up at all, admitted to Medical center  with AKI and rhabdomyolysis
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Mobility decreased, Rhabdomyolysis, Troponin I increased
Clinical narrative: Patient could not ambulate for entire 2 days after vaccination and had to be lying down on the floor unable to get up at all, admitted to Medical center  with AKI and rhabdomyolysis
Age: 62.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: soreness in his arm; 2nd dose not receivd yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Influenza vaccine for prophylaxis.   On 19-OCT-2021, the patient received the 1st dose of Shingrix (left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 19-OCT-2023, the patient received the 1st dose of Influenza vaccine. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: soreness in his arm) and incomplete course of vaccination (Verbatim: 2nd dose not receivd yet). The outcome of the pain in arm was resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 10-NOV-2023 The patent mentioned that he had his first dose of the Shringrix vaccine in October 19th of 2021 and never received the 2nd dose. The patient had no lot number or expiry date, or route of administration to provide. The patient stated he probably received the 1st dose of Shingrix in his left arm, but was not sure. The patient also reported that he was pretty sure he received a flu shot (unknown product) at the same time. The patient reported that he had soreness in his arm for a few days after receiving Shingrix. No further information provided about this event. The patient stated that he left the country and was unable to schedule a second dose. The patient enquired that as a very healthy 65 year old, was it recommended to start over and get two shots and was there a significant risk in simply getting a booster now or alternatively was there a significant risk in getting two more now. The consent to follow up with Healthcare professional was obtained, however the patient did not had a primary care physician, and was not able to provide any Healthcare professional information. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity
Clinical narrative: allergic to the product; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of drug allergy in a 83-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced drug allergy (Verbatim: allergic to the product). The outcome of the drug allergy was not reported.   The reporter considered the drug allergy to be related to Shingles vaccine.     The company considered the drug allergy to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 11-NOV-2023 A patient was reported for her-self. She started treatment on an unreported date with shingles vaccine at an unreported dose, route and frequency of administration for an unreported indication.  It was reported the patient was allergic to the product.  No further follow-up is anticipated.
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: inadvertently received a dose ofBoostrix instead of a DTaP on 24-APR-2023/wrong vaccine administered; Inappropriate age at vaccine administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24-APR-2023, the patient received Boostrix. On 24-APR-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: inadvertently received a dose ofBoostrix instead of a DTaP on 24-APR-2023/wrong vaccine administered) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK recipt date: 10-NOV-2023 The reporter reported that a 3 year old patient inadvertently received a dose of Boostrix instead of a DTaP, which led to wrong vaccine administered and inappropriate age at vaccine administration. The caller declined to provide date of birth or initials. The reporter consented to follow up via email would be okay.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the first dose of Twinrix on 12Jun2023, and the second dose today on 10Nov2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (could have received the 1st dose of Twinrix in May 2023).   On 10-NOV-2023, the patient received the 2nd dose of Twinrix. On 10-NOV-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of Twinrix on 12Jun2023, and the second dose today on 10Nov2023.). The outcome of the drug dose administration interval too long 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: 10-NOV-2023 The pharmacist reported that the patient had received 2 doses of Twinrix. At the end of the call pharmacist stated that it was possible that the patient started the series in his physician's office and could have received the first dose in May 2023. The patient received second dose of Twinrix later than the recommended interval, which led to drug dose administration too long. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Fluarix QIV vaccine experienced temperature excursion that occurred for more than 72 hours; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   On 26-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season .5 ml. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: Fluarix QIV vaccine experienced temperature excursion that occurred for more than 72 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2023 The reporter was pharmacist. The reporter reported that that reports Fluarix QIV vaccine experienced temperature excursion that occurred for more than 72 hours. It occurred over several days where temperature fluctuated between 28 to 29 to 55 Fahrenheit. The product received Fluarix QIV vaccine after temperature excursion, which led to incorrect storage of drug. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 19th October 2021), Flulaval and Shingrix (received 1st dose on 19th October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-NOV-2022 The reporter was patient's husband. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter also states the wife received a Flulaval 21/22 SYR (no further information provided) at the same time. No lot number expiry date , route of administration, or location of administration was provided for either vaccine. The patient was on the phone in the background on the call but did not speak directly with the patient. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on12th September 2018).   On 14-JUL-2023, the patient received the 2nd dose of Shingrix. On 14-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date:10-NOV-2023 The reporter was consumer. The reporter reported that patient was confused about whether she needs another shingles shot due to a reminder sent to her on her phone that she needs another shingles shot. The patient had no further information to provide about this event. The patient reports she probably received both vaccines in her right arm, but she was not sure. The patient received 2nd dose later than recommended which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Needle issue, Underdose
Clinical narrative: during administration of Arexvy, the needle leaked vaccine out onto the patient's arm and she did not get a full dose; during administration of Arexvy, the needle leaked vaccine out onto the patient's arm and she did not get a full dose; during administration of Arexvy, the needle leaked vaccine out onto the patient's arm and she did not get a full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number T4AP4, expiry date 26-MAR-2025) for prophylaxis.   On 10-NOV-2023, the patient received Arexvy. On 10-NOV-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: during administration of Arexvy, the needle leaked vaccine out onto the patient's arm and she did not get a full dose), inadvertent exposure to vaccine (Verbatim: during administration of Arexvy, the needle leaked vaccine out onto the patient's arm and she did not get a full dose) and exposure via skin contact (Verbatim: during administration of Arexvy, the needle leaked vaccine out onto the patient's arm and she did not get a full dose). The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional Information: GSK Receipt Date: 10-NOV-2023 The pharmacist reported during administration of Arexvy, the needle leaked vaccine out onto the patient's arm and she did not get a full dose, which led to incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. The reporter consented to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient was due for Pediarix but got Kinrix instead; a patient who is 5 months old inadvertently received a dose of Kinrix; a patient who is 5 months old inadvertently received a dose of Kinrix/Kinrix was the patient's 2nd DTaP and 2nd Polio; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 01-NOV-2023, the patient received Kinrix. On 01-NOV-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient was due for Pediarix but got Kinrix instead), inappropriate age at vaccine administration (Verbatim: a patient who is 5 months old inadvertently received a dose of Kinrix) and inappropriate schedule of vaccine administered (Verbatim: a patient who is 5 months old inadvertently received a dose of Kinrix/Kinrix was the patient's 2nd DTaP and 2nd Polio). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule 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: 10-NOV-2023 The nurse reported that a patient who was 5 months old inadvertently received a dose of Kinrix, which led to inappropriate age at vaccine administration. The patient was due for Pediarix but got Kinrix instead, which led to wrong vaccine administered.  The Kinrix was the patient's 2nd DTaP and 2nd Polio dose, which led to inappropriate schedule of vaccine administered. The reporter stated, had they received Pediarix, it would have been the patients 3rd dose of Hepatitis B. The reporter consented to follow up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: injected with Shingrix adjuvant, not the reconstituted product; injected with Shingrix adjuvant, not the reconstituted product; 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 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7ta92, expiry date 29-SEP-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: injected with SHINGRIX ADJUVANT, not the reconstituted product) and inappropriate dose of vaccine administered (Verbatim: injected with SHINGRIX ADJUVANT, not the reconstituted product). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 10-NOV-2023 The reporter was health care professional (HCP).   The patient was injected with Shingrix adjuvant, not the reconstituted product (Inappropriate Reconstitution Technique), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Pharmacist stated that a patient received their first dose of Shingrix three years ago.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Pharmacist stated that a patient received their first dose of Shingrix three years ago.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:10-NOV-2023 Caller declined to provide more information. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Shingrix incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-NOV-2023, the patient received Shingrix. On 09-NOV-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Shingrix incomplete dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date:10-NOV-2023 Pharmacist reported while administering Shingrix the needle was not screwed correctly to the syringe and most of the vaccine was administered but saw one or two drops leaking, which led to incomplete dose administered. Information about patient and vaccine requested but call was decline because caller was not at facility at the moment of call. The reporter consented to follow up via email.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: having soreness in the arm where the vaccine was administered/ pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-NOV-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm). On 10-NOV-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: having soreness in the arm where the vaccine was administered/ pain at the injection site). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK receipt date:10-NOV-2023 The reporter was the brother of the patient.  The reporter stated that the vaccine was administered at a local pharmacy. The reporter stated that patient had soreness in the arm where the vaccine was administered. The reporter stated that patient had pain at the injection site. It was unknown in which arm the vaccine was administered.  Lot and Expiry date were unknown.   No additional information was provided. Not all information was available.  Consent for follow up was not obtained.
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: the interchangeability of Bexsero and Trumenba.; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number 5P2P7) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 09-JUN-2023, the patient received the 1st dose of Bexsero. On an unknown date, the patient received TRUMENBA. On 09-JUN-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: the interchangeability of Bexsero and Trumenba.). The outcome of the interchange of vaccine products 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: 10-NOV-2023 A Registered nurse contacted inquiring about Bexsero and what information is available about the information available for the interchangeability of Bexsero and Trumenba which led to interchange of vaccine products. They provided partial information about event, patient and vaccine. The reporter consented to follow up.  The vaccine administration facility is the same as primary reporter.
Sex: F
Vaccine: RSV
Symptoms: Blood test normal, Extremity necrosis
Clinical narrative: arm necrosis; This serious case was reported by a consumer via call center representative and described the occurrence of necrosis in a 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 necrosis (Verbatim: arm necrosis) (serious criteria GSK medically significant). The outcome of the necrosis was not resolved.   It was unknown if the reporter considered the necrosis to be related to Arexvy.     It was unknown if the company considered the necrosis to be related to Arexvy.   Additional Information: GSK Receipt Date:13-NOV-2023 Consumer reported that the arm was necrotic after RSV injection. The reporter stated that medical attention had been sought which included several emergency room visits. The reporter stated that she was given permission to go on a cruise by her doctor and when she returned her arm was very necrotic. Consumer reported that she saw doctor on Thursday and bloodwork was okay. The patient followed all medical guidelines and it was still necrotic. Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SUFFERED BECAUSE OF THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date, the patient experienced suffered because of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffered because of the vaccine was not reported. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Coronary artery thrombosis, Myocardial infarction
Clinical narrative: BLOOD CLOT IN HEART LAD (LEFT ANTERIOR DESCENDING ARTERY); HEART ATTACK; CARDIAC ARREST; This spontaneous report received from a consumer concerned a 58 year old, male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (rarely), and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient was on no medications prior to the event. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number series 1) (suspension for injection, route of admin not reported, batch number: 1855190 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-OCT-2021 in left arm for covid-19 prophylaxis. It was unknown if patient experienced any adverse event after covid-19 vaccine (Dose number series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 27-APR-2022 in left arm for covid-19 prophylaxis. Age at time of vaccination 56 years old. No concomitant medications were reported.  On 20-OCT-2023, the patient experienced blood clot in heart LAD (left anterior descending artery), the clot was presumably in heart for long time and passed while patient was running on treadmill. The patient had a heart attack that caused cardiac arrest (Dose number series 2). The CPR (Cardiopulmonary resuscitation) was performed on patient. The patient was on no medication prior to event. The patient had to put stent in and currently wearing external defibrillator. The patient was on acetylsalicylic acid (aspirin), blood thinner, statins. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in heart lad (left anterior descending artery), heart attack and cardiac arrest was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231138879-blood clot in heart LAD (left anterior descending artery), heart attack,  cardiac arrest. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.