chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Hives and itching and red rash at the top of right arm. Also around the neck and upper back, some starting on stomach, neck was the worst area. Mother gave PO Benadryl, reports she also gave two more doses throughout the night. Says he did not need any more doses today. Says the rash is mostly gone. Denied any shortness of breath, did go to the ER just in case he needed to be seen, mother reports he did not have to be seen by ER staff.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Confusional state, Muscle tightness, Peripheral swelling, Seizure
Clinical narrative: Patient was on the couch, felt tension go up their neck, and then was having cycles of seizure activity that lasted a couple hours. Says when they do have seizures due to their disorder they do not last this long. Patient said their arm swelled up and it is swollen. Patient says today they still feel confused and out of it.
Age: 95.0
Sex: F
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Client reports some swelling to right arm where vaccine was administered. Denies redness, but pain to the upper arm down to the wrist area. Client reports unable to raise arm up.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 YEAR OLD PATIENT RECIEVE PFIZER COVID VACCINE WHICH IS RECOMMENDED FOR AGES 12 AND OLDER. PATIENT DISPLAYED NO SYMPTOMS.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a combination vaccine of Dtap and Polio. Patient should have been given these 2 vaccines separately. This dose still counts as a valid dose and does not have to be repeated.
Age: 29.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: G3P1  29WKS 4DAYS PREGNANT EDD 12/27/24
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Injection site rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: patient came in 7 days after vaccination with a raised red and scaly rash around the injection site and about 8-10 inches of the area around the site. Rash was itchy and tender. Patient was referred onto her primary care doctor for evaluation and treatment with steroids if applicable.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Chills, Culture urine negative, Dizziness, Fatigue
Clinical narrative: fatigue, chills, shaking, the night of the vaccine, same the following day. Felt good the next day and exercised although very tired. The following day very nauseous,  light headed,  achy and shaking. High BP208/150 but came down throughout the day. Called a nurse line for advice and she called the rescue squad. They checked me out and all vitals were normal. Did not go to hospital. Felt weak the rest of the day, ate very little but the next morning felt nauseous again and tired called my gp and got checked out by her
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test negative, Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: fatigue, chills, shaking, the night of the vaccine, same the following day. Felt good the next day and exercised although very tired. The following day very nauseous,  light headed,  achy and shaking. High BP208/150 but came down throughout the day. Called a nurse line for advice and she called the rescue squad. They checked me out and all vitals were normal. Did not go to hospital. Felt weak the rest of the day, ate very little but the next morning felt nauseous again and tired called my gp and got checked out by her
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: fatigue, chills, shaking, the night of the vaccine, same the following day. Felt good the next day and exercised although very tired. The following day very nauseous,  light headed,  achy and shaking. High BP208/150 but came down throughout the day. Called a nurse line for advice and she called the rescue squad. They checked me out and all vitals were normal. Did not go to hospital. Felt weak the rest of the day, ate very little but the next morning felt nauseous again and tired called my gp and got checked out by her
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: pain in her arm two weeks after vaccinations
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain
Clinical narrative: PATIETN CALLED SHE HAD RECICVED HER COVID VACCINE ON MONDAY AND THAT NIGHT A LUMP DEVLOPED WHERE THE VACCINE WAS GIVEN. IT IS NOT COLD OR HOT TOUCH, WAS NOT ITCHY, WAS TENDER/SORE. PATIENT HAS NOT DONE ANY IBUPROFEN OR TYLENOL FOR PAIN AND HAS NOT USED ICE. EDUCATED APTIETN SHE COULD USE THOSE TO ASSIST WITH PAIN/SWELLING
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Adrenal insufficiency, Blood pressure decreased, Blood pressure increased, Colitis, Computerised tomogram
Clinical narrative: pt states less than an hour after being vaccinated she went back to work clinic and developed a massive headache. Her head hurt so bad she had to get a doctor check her BP. She was sent to a clinic to get checked out. They sent her straight to the Emergency room for EKG. The EKG showed that she had SVT. She was admitted for a couple of days to be treated. She was prescribed heart medication. After being discharged from hospital she had to continue to monitor her BP and heart rate because it would become elevated to where she feel dizzy and her head hurts and then it will drop and cause her to feel very fatigued. She has been following up with doctors at Clinic. She is now having new symptoms where she feels she has something moving thoughout the body and causing her spit up unidentified material. She describes it looking like little bead of wax with spots red, black or yellow. This sensation is felt from head to toe. She feels like something is tearing her apart from the inside out. She had something come out of her cheek and some things come out from other parts of her body. She developed skin lessions.  She since has been treated by an infectious disease doctor, and endocronologist, dermatologist, gastroenterologist, neurologist and a hemotologist. She was diagnosed with  endocranial hypotension, papilledema, she is adrenal insufficient, diverticulitis and colitis. She has an appt to see a heart doctor tomorrow.  She keeps getting new different symptoms all of the time.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Dizziness, Electrocardiogram abnormal, Fatigue, Headache
Clinical narrative: pt states less than an hour after being vaccinated she went back to work clinic and developed a massive headache. Her head hurt so bad she had to get a doctor check her BP. She was sent to a clinic to get checked out. They sent her straight to the Emergency room for EKG. The EKG showed that she had SVT. She was admitted for a couple of days to be treated. She was prescribed heart medication. After being discharged from hospital she had to continue to monitor her BP and heart rate because it would become elevated to where she feel dizzy and her head hurts and then it will drop and cause her to feel very fatigued. She has been following up with doctors at Clinic. She is now having new symptoms where she feels she has something moving thoughout the body and causing her spit up unidentified material. She describes it looking like little bead of wax with spots red, black or yellow. This sensation is felt from head to toe. She feels like something is tearing her apart from the inside out. She had something come out of her cheek and some things come out from other parts of her body. She developed skin lessions.  She since has been treated by an infectious disease doctor, and endocronologist, dermatologist, gastroenterologist, neurologist and a hemotologist. She was diagnosed with  endocranial hypotension, papilledema, she is adrenal insufficient, diverticulitis and colitis. She has an appt to see a heart doctor tomorrow.  She keeps getting new different symptoms all of the time.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Intracranial hypotension, Laboratory test, Magnetic resonance imaging, Papilloedema
Clinical narrative: pt states less than an hour after being vaccinated she went back to work clinic and developed a massive headache. Her head hurt so bad she had to get a doctor check her BP. She was sent to a clinic to get checked out. They sent her straight to the Emergency room for EKG. The EKG showed that she had SVT. She was admitted for a couple of days to be treated. She was prescribed heart medication. After being discharged from hospital she had to continue to monitor her BP and heart rate because it would become elevated to where she feel dizzy and her head hurts and then it will drop and cause her to feel very fatigued. She has been following up with doctors at Clinic. She is now having new symptoms where she feels she has something moving thoughout the body and causing her spit up unidentified material. She describes it looking like little bead of wax with spots red, black or yellow. This sensation is felt from head to toe. She feels like something is tearing her apart from the inside out. She had something come out of her cheek and some things come out from other parts of her body. She developed skin lessions.  She since has been treated by an infectious disease doctor, and endocronologist, dermatologist, gastroenterologist, neurologist and a hemotologist. She was diagnosed with  endocranial hypotension, papilledema, she is adrenal insufficient, diverticulitis and colitis. She has an appt to see a heart doctor tomorrow.  She keeps getting new different symptoms all of the time.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Regurgitation, Sensory disturbance, Skin lesion, Supraventricular tachycardia
Clinical narrative: pt states less than an hour after being vaccinated she went back to work clinic and developed a massive headache. Her head hurt so bad she had to get a doctor check her BP. She was sent to a clinic to get checked out. They sent her straight to the Emergency room for EKG. The EKG showed that she had SVT. She was admitted for a couple of days to be treated. She was prescribed heart medication. After being discharged from hospital she had to continue to monitor her BP and heart rate because it would become elevated to where she feel dizzy and her head hurts and then it will drop and cause her to feel very fatigued. She has been following up with doctors at Clinic. She is now having new symptoms where she feels she has something moving thoughout the body and causing her spit up unidentified material. She describes it looking like little bead of wax with spots red, black or yellow. This sensation is felt from head to toe. She feels like something is tearing her apart from the inside out. She had something come out of her cheek and some things come out from other parts of her body. She developed skin lessions.  She since has been treated by an infectious disease doctor, and endocronologist, dermatologist, gastroenterologist, neurologist and a hemotologist. She was diagnosed with  endocranial hypotension, papilledema, she is adrenal insufficient, diverticulitis and colitis. She has an appt to see a heart doctor tomorrow.  She keeps getting new different symptoms all of the time.
Age: 0.33
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: INADVERTENLY GIVEN FLU VACCINE NO ADVERSE REACTION NOTED AT THE TIME .
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: was at clinic and was told pt needed 2nd dose shingrix, when we billed it back at pharmacy discovered they had already had 2 shots so pt rec'd 3rd shingles vaccine
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: was at a nursing home clinic was told pt needed RSV vaccine. when we billed it later it was discovered pt had already rec'd the rsv vaccine
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: patient stated full body rash about 18 hours after vaccine.  was itchy.  came to pharmacy 10/16/24 and said rash had pretty much resolved except her hands or feet... employee looked and didnt see anything at that point.  the shot site looked normal with no rash, swelling or redness.  patient stated shot site never had redness or swelling in shot area.  She said she used hydrocortisone and got relief, and the only itchy part at this point was her feet and it" wasnt horrible. "  She stated she has had many vaccines in the past with no problems,  Patient contacted dr
Age: 85.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood test normal, Rash macular
Clinical narrative: Red blotches on right inner arm, spread to left inner arm then to left and right inner legs  No blotches on torso
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Injection site pain
Clinical narrative: Patient described abnormal pain in left deltoid upon injection of vaccine, she felt like it hit bone or a nerve. The pain in her shoulder decreased within a few minutes but she now reported pain near her left elbow when she moved her arm.  No confirmed injury yet. I advised icing the area and taking ibuprofen.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was given to nursing home patient during an on site vaccine clinic at senior living memory care unit. Upon processing the claim for the vaccine it was realized that the patient is 63 not 65. The nursing facility, medical proxy and primary care provider were contacted and no adverse reaction is expected.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MNQ, TDAP
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: No adverse reaction occurred during this event as it was just a syringe malfunction. Incident Reported in portal    As writer was administering MMRV on left arm, needle leakage occurred due to a needle malfunction, resulting in a loss of the majority of the vaccine (Estimated loss of more than half of vaccine)  MMRV information not documented in patient chart as administered since this vaccine was wasted.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, MMRV, PNC20
Symptoms: Wrong product administered
Clinical narrative: Patient was given two Hep B vaccines instead of Hep B and Hep A. There was a Hep B in the Pediarix and a Hep B was pulled instead of Hep A
Age: 64.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: On October 15, 2024 the patient came to the pharmacy to receive the RSV vaccine (Abrysvo). After the patient received the vaccine and leave the pharmacy, we realized the vaccine wasn't reconstituted. The sterile water was administered without the active ingredient. RPh called to the patient and informed her the event. The patient said, she is coming on Thursday, (October 17, 2024) to get the vaccine.  No adverse event was reported.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chest discomfort, Dizziness, Lip swelling, Paraesthesia oral, Rash
Clinical narrative: About 15 minutes after receiving immunizations, patient began experiencing chest tightness.  Within 5 minutes, red patches began to be seen on her neck and she had some lightheadedness. Patient was given 25mg of diphenhydramine.  3 minutes later, the patient had lip tingling and was starting to complain of slight wheezing.  EMT administered 0.3mg epinephrine.  Patient was then transported via ambulance for observation.  She was released a few hours later and was feeling better.
Age: 30.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash erythematous, Wheezing
Clinical narrative: About 15 minutes after receiving immunizations, patient began experiencing chest tightness.  Within 5 minutes, red patches began to be seen on her neck and she had some lightheadedness. Patient was given 25mg of diphenhydramine.  3 minutes later, the patient had lip tingling and was starting to complain of slight wheezing.  EMT administered 0.3mg epinephrine.  Patient was then transported via ambulance for observation.  She was released a few hours later and was feeling better.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Blood test, Cough, Dyspnoea, Electrocardiogram, Headache
Clinical narrative: Morning of 9/19/24 woke up with headache, achy body, hurt to move, trouble breathing, runny nose and horrible cough
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Rhinorrhoea, X-ray
Clinical narrative: Morning of 9/19/24 woke up with headache, achy body, hurt to move, trouble breathing, runny nose and horrible cough
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Chills, Myalgia
Clinical narrative: Severe chills; body temperature was 95.4; muscle aches that occurred in waves especially running down my legs.  Took 2 extra-strength Tylenols.  Did not help.  Took two Advils at 2 a.m.   Symptoms started to abate by 9 a.m.   Was not fully recovered until the following day.
Age: 8.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: form received in pt's chart and used was not for the pt. The pt was inadvertently given the hep a vaccine 9 days too soon.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt had adverse reaction in L deltoid after receiving Covid injection.  Unknown approximate date.  She has experienced redness, heat to the touch, pain, swelling , and itching in and around injection site.  Also reported some fluid underlay around the injection site.  She does have a hx of cellulitis and concerned it may have been triggered by vaccine response.  She is being treated with antihistamines to help control symptoms
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Pt had adverse reaction in L deltoid after receiving Covid injection.  Unknown approximate date.  She has experienced redness, heat to the touch, pain, swelling , and itching in and around injection site.  Also reported some fluid underlay around the injection site.  She does have a hx of cellulitis and concerned it may have been triggered by vaccine response.  She is being treated with antihistamines to help control symptoms
Age: 1.58
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Death, Dyskinesia, Irritability, Pulse absent, Resuscitation
Clinical narrative: Of note, patient also received Beyfortus injection with vaccinations. He went home from appointment, took a nap, became fussy when he woke. Unsure if he had fever but felt warm. Then had event at home where he made some abnormal movements and then became unresponsive. CPR was started immediately, transported to the hospital where he received CPR and multiple doses of epi. Remained pulseless throughout and was pronounced deceased after an hour of attempted resuscitation.
Age: 1.58
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Skin warm, Unresponsive to stimuli
Clinical narrative: Of note, patient also received Beyfortus injection with vaccinations. He went home from appointment, took a nap, became fussy when he woke. Unsure if he had fever but felt warm. Then had event at home where he made some abnormal movements and then became unresponsive. CPR was started immediately, transported to the hospital where he received CPR and multiple doses of epi. Remained pulseless throughout and was pronounced deceased after an hour of attempted resuscitation.
Age: 63.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood glucose increased, Condition aggravated, Type 2 diabetes mellitus
Clinical narrative: Patient came in on 10/16 to report that after receiving both vaccines above, patient went to hospital on 10/14 with severely high glucose readings in the 600s.  Patient mentioned that Dr said it was due to the vaccines.  Patient was discharged from hospital on 10/16 from this, with increased insulin requirement and changing up of diabetes medications.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Neck pain
Clinical narrative: Patient got Fluad on 10-11-24.  Came in on 10-16-24 and informed us that she started having extreme neck and shoulder pain on 10-13-24.  She has no redness or swelling at site of injection.  She can raise her arm and rotate it with no issues.  Patient has seen her chiropractor twice since the vaccine for the pain with no relief.  Patient is going to call primary care dr.
Age: 78.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Fatigue, Influenza, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient felt like she was coming down with the flu and fatigued on 10/15.  Patient developed a ovular rash at injection site 3 inches in diameter. Rash is not raised. Does not itch. Site is a little warm and sore. No other issues.
Age: 72.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: On 10/15/24, patient received both the Fluzone High dose influenza vaccine and Comirnaty Covid-19 vaccine. Patient has never had a reaction to either vaccine in the past. Vaccines were administered by pharmacist, and patient left the pharmacy and premise without incident. Patient called today 10/16/24 to inform us that she had an anaphylactic reaction requiring an emergency department visit in the evening.
Age: 13.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Inflammation, Palpitations, Rash erythematous, Skin exfoliation
Clinical narrative: Rash same day, rash got red and larger 4 inches in diameter. Next day brighter red, swelling, inflammation, skin (peeling). Cough started the day after vaccine, heart racing. no pain. Swelling, rash lasted 9-10 days, faded and was pink for 15 days from date of injection. Dry cough continues today 10-16-24. Patient gets similar reaction to every shot for the last 25 years but the shingles shot reaction was more severe and lasted longer. The injection site has healed by now but cough remains. The doctor was not sure that the cough is related to the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Rash same day, rash got red and larger 4 inches in diameter. Next day brighter red, swelling, inflammation, skin (peeling). Cough started the day after vaccine, heart racing. no pain. Swelling, rash lasted 9-10 days, faded and was pink for 15 days from date of injection. Dry cough continues today 10-16-24. Patient gets similar reaction to every shot for the last 25 years but the shingles shot reaction was more severe and lasted longer. The injection site has healed by now but cough remains. The doctor was not sure that the cough is related to the vaccine.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given 3yrs and up Influenza vaccine, Patient age is 2yrs old.
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 5.0
Sex: M
Vaccine: RV5
Symptoms: Irritability, Product administered to patient of inappropriate age, Respiratory symptom
Clinical narrative: Patient received vaccine in error at age 5.  He had the 3 primary series as a newborn.  He had irritability day 1 and mild URI symptoms day 2-5.  No fever or signs of Intussusception.
Age: 50.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pain, Periorbital swelling, Swelling face
Clinical narrative: PATIENT RECEIVED VACCINES ON 10/15 AND REPORTED TO PHARMACY ON 10/16 WITH COMPLAINTS OF MILD SWEELING  AND PAIN UNDER HER LEFT EYE AND CHEEK.  SHE ALOS COMPLAINED OF PAIN AT INJECTION SITE. SHE DID NOT HAVE ANY NUMBNESS, TINGLING OR PAIN ANYWHERE ELSE. PATIENT THOUGHT IT WAS A REACTION FROM SHNGLES VACCINE.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Burning sensation, Erythema, Muscle swelling, Myalgia
Clinical narrative: started burning. got in the shower, and a little redness and a small blister appeared. Skin opened and muscle feels swollen, sore and tender. Redness extended
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Skin disorder
Clinical narrative: started burning. got in the shower, and a little redness and a small blister appeared. Skin opened and muscle feels swollen, sore and tender. Redness extended
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Patient experienced a 3 inch diameter circular welt on left deltoid area surrounding area of immunization. S/S: Redness, warm to touch, tender to touch. Denies fever, aches, headache. Denies any history of allergic reaction to prior immunizations, including flu. Welt has lasted over 48 hours,. No treatment required.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received high dose vaccine, under 65 y/o
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Pt had a local reaction on her left upper arm experiencing swelling, tenderness, and bruising when she got the Pneumonia Vaccine (PCV20) on 08/19/2024. Symptoms lasted for 30 days following symptom onset on 08/19/2024.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Large red, hot welt at injection site and itchy hands
Age: 3.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: Vaccine stored in a fridge that had a temperature excursion and inadvertently administered to patient.
Age: 53.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash dots began on upper chest and have started spreading downward. Currently non irritating.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Axillary pain, Burning sensation, C-reactive protein increased
Clinical narrative: Burning in my left axilla with intense pain with any left arm movement. Was diagnosed in the emergency department with Brachial Plexitis via brachial plexus MRI. I was instructed to take 800mg of ibuprofen TID and then started steroids (medrol dose pack on 10/13/24). My health care team is now concerned that I have brachial neuritis/parsonage turners syndrome. I'm currently experiencing weakness through my left shoulder girdle and pain at my left scapula and wrist.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Electrocardiogram normal, Lymphadenopathy, Magnetic resonance imaging abnormal, Musculoskeletal pain
Clinical narrative: Burning in my left axilla with intense pain with any left arm movement. Was diagnosed in the emergency department with Brachial Plexitis via brachial plexus MRI. I was instructed to take 800mg of ibuprofen TID and then started steroids (medrol dose pack on 10/13/24). My health care team is now concerned that I have brachial neuritis/parsonage turners syndrome. I'm currently experiencing weakness through my left shoulder girdle and pain at my left scapula and wrist.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgic amyotrophy, Oedema, Pain, Ultrasound chest, X-ray limb
Clinical narrative: Burning in my left axilla with intense pain with any left arm movement. Was diagnosed in the emergency department with Brachial Plexitis via brachial plexus MRI. I was instructed to take 800mg of ibuprofen TID and then started steroids (medrol dose pack on 10/13/24). My health care team is now concerned that I have brachial neuritis/parsonage turners syndrome. I'm currently experiencing weakness through my left shoulder girdle and pain at my left scapula and wrist.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blindness, Blood magnesium, Culture urine
Clinical narrative: Dizzy/faint, seeing duplicate of objects and people, hot flashes, loss of Vision, taste, smell, couldn t feel my body/ went numb, couldn?t breath normally, Nausea, Palpitations.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Diplopia, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Dizzy/faint, seeing duplicate of objects and people, hot flashes, loss of Vision, taste, smell, couldn t feel my body/ went numb, couldn?t breath normally, Nausea, Palpitations.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Hot flush, Hypoaesthesia, Influenza virus test, Metabolic function test
Clinical narrative: Dizzy/faint, seeing duplicate of objects and people, hot flashes, loss of Vision, taste, smell, couldn t feel my body/ went numb, couldn?t breath normally, Nausea, Palpitations.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, SARS-CoV-2 test, Syncope, Troponin
Clinical narrative: Dizzy/faint, seeing duplicate of objects and people, hot flashes, loss of Vision, taste, smell, couldn t feel my body/ went numb, couldn?t breath normally, Nausea, Palpitations.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Dizzy/faint, seeing duplicate of objects and people, hot flashes, loss of Vision, taste, smell, couldn t feel my body/ went numb, couldn?t breath normally, Nausea, Palpitations.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: I have swelling in my left arm starting at the upper arm muscle with redness and itching.  This occurred on 10/15 which is after the injection which was given on 10/14 at 12:43 pm.  On day three (10/17) the swelling continued from my upper arm downward extending to my elbow bend.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE occurred; the patient received a dose of PROQUAD after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient with unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-OCT-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, 1 dose, administered for prophylaxis (lot #Y012074, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 05-JAN-2026; strength, dose, route of administration, and anatomical location were not provided). It was reported that the vaccine underwent a temperature excursion which was 10.2 degrees Fahrenheit (F) for 1 hour 30 minutes (product storage error). No previous temperature excursion was reported. It was confirmed no other adverse event (AE) occurred (No adverse event). No product quality complaint (PQC).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA001417:MSD US-009507513-2410USA001407:MSD US-009507513-2410USA001596:MSD
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood cholesterol increased, Colorectal adenoma, Full blood count abnormal, Papilloma viral infection, Vitamin B12 increased
Clinical narrative: patient was diagnosed HPV+ on 18SEP2024 after receiving a full vaccination series of GARDASIL in 2007.; High B12; high cholesterol; CBC abnormal; Tumor adenoma of colon (2019); This spontaneous report has been received from medical assistant, regarding a 32-year-old non-pregnant female patient. The patient's medical history included herpes 2 infection, depression, intrauterine device (IUD) interaction, and chronic gastroesophageal reflux disease  (GERD). The patient's concurrent conditions and concomitant medications were not provided. No known allergies.    On 21-FEB-2007, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection, intramuscularly administrated (strength, dose, frequency, vaccination scheme, site of administration, and expiration date were not provided; lot # 1208F which has been verified to be a valid number for vial formulation) as prophylaxis. On 21-MAR-2007, the patient was vaccinated with the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection, intramuscularly administrated (strength, dose, frequency, vaccination scheme, site of administration, and expiration date were not provided; lot # 1208F which has been verified to be a valid number for vial formulation) as prophylaxis. On 19-DEC-2007, the patient was vaccinated with the third dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection, intramuscularly administrated (strength, dose, frequency, vaccination scheme, site of administration, and expiration date were not provided; lot # 1208F which has been verified to be a valid number for vial formulation) as prophylaxis.   On unspecified date in 2019, the patient experienced a tumor adenoma of colon (colorectal adenoma). Moreover, after the patient received full vaccination series, on 18-SEP-2024, the patient experienced human papillomavirus infection (HPV+) with a diagnosis of any one or combination of HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, or 68. In addition, the patient had the following lab results: high B12, high cholesterol, and complete blood count was abnormal. The patient had not yet received a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Moreover, the patient sought medical attention. No treatment was administrated for the events. At the reporting time, the outcome of the event of colorectal adenoma was not provided, whereas for the events of human papillomavirus infection, high B12, high cholesterol, and complete blood count abnormal was reported as not recovered. No further information was available.  The causal relationship between suspect vaccine with the events was not reported.
Age: 58.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed no symptomatic adverse events were reported; HCP states that the vaccine expired on 25-SEP-2024 and was administered on 8-OCT-2024; This spontaneous report has been received from a medical assistant regarding  a 58-year-old female patient. Information regarding medical history, concurrent conditions and concomitant therapies was not reported.  On 8-OCT-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, for prophylaxis, 0.5 milliliters, lot number W027449 which has been verified to be valid, expiration date reported and validated as 25-SEP-2024. (scheme, route of administration and anatomical site not reported). (Expired vaccine used). The reporter confirmed the vaccine did not have any temperature excursions. No symptomatic adverse events were reported.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Condition aggravated, Systemic lupus erythematosus
Clinical narrative: I have gotton Lupus Flars; This serious case was reported by a consumer via interactive digital media and described the occurrence of sle flare in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and an unknown time after receiving Influenza vaccine, the patient experienced sle flare (Verbatim: I have gotton Lupus Flars) (serious criteria GSK medically significant). The outcome of the sle flare was not reported.   The reporter considered the sle flare to be related to Shingles vaccine.     The company considered the sle flare to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-OCT-2024 This case was reported by a patient via interactive digital media. The patient had gotten lupus flares to Shingles shot and the High dose flu shot. The patient asked question was this vaccine that had for respiratory syncytial virus vaccine with lupus. The reporter considered the sle flare to be related to High dose flu shot.; Sender's Comments: Systemic lupus erythematosus is an unlisted event which is considered unrelated to GSK  vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I had two doses of Shingrix but they were 17 months apart; 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in SEP-2020).   In FEB-2022, the patient received the 2nd dose of Shingrix. In FEB-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I had two doses of Shingrix but they were 17 months apart). The outcome of the drug dose administration interval too long was not applicable.  Additional Information: GSK Receipt Date: 03-OCT-2024 The patient self-reported this case. The patient had two doses of Shingrix but they were 17 months apart, which was delayed than the recommended time interval, which led to lengthening of the vaccination schedule. The reporter asked, if he/she should get another 2 dose series or not. The reporter got response that, Shingrix was administered as a 2 dose series. The FDA (Food and Drug Administration) approved schedule does not include a booster dose of Shingrix or a repeat of the series. The patient was advised to consult with their healthcare provider about this guidance and their individual situation.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; she still got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she still got the shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-OCT-2024 The case was received from the consumer via interactive digital media. The patient was sister of the reporter. The reporter stated that everybody was so eager to go stand in line for a magical vaccine, if it wasn't so ridiculous it would be funny. The patient got the vaccine and she still got the shingles, then she kept urging him/her to get the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Product administered to patient of inappropriate age, Therapy non-responder
Clinical narrative: patient was not immune; Engerix-B booster dose 20mcg/1ml a 19 year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 19-year-old female patient who received HBV (Engerix B adult) (batch number 92NK2, expiry date 29-SEP-2026) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On 17-SEP-2024, the patient received Engerix B adult. On 15-DEC-2005, the patient received the 3rd dose of Hepatitis B vaccine. On 18-AUG-2005, the patient received the 2nd dose of Hepatitis B vaccine. On 13-JUN-2005, the patient received the 1st dose of Hepatitis B vaccine. On 17-SEP-2024, an unknown time after receiving Engerix B adult, not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: Engerix-B booster dose 20mcg/1ml a 19 year old patient). On an unknown date, the patient experienced therapy non-responder (Verbatim: patient was not immune). The outcome of the therapy non-responder and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-SEP-2024 and 19-SEP-2024 The nurse explained that a medical assistant administered an Engerix-B booster dose 20mcg/1ml (indicated for patients 20 years and older) to a 19-year-old patient on 17th September 2024 which led to inappropriate age at vaccine administration. The patient received 3 prior doses of Hepatitis B vaccine (unknown brand, lot number and expiration date) on 13th June 2005, 18th August 2005 and 15th December 2005. The nurse called back on 19th September 2024 and mentioned that the Engerix-B booster dose 20mcg/1ml administered to a 19-year-old patient on September 17th 2024 it was prescribed by the doctor since they did titers and patient was not immune which led to therapy non-responder.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: The dose administered on 18Sep2024/ Extra Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number JP392, expiry date 21-APR-2025) for prophylaxis.   Previously administered products included AREXVY (1st dose received on 09-SEP-2023).   On 18-SEP-2024, the patient received the 2nd dose of Arexvy. On 18-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: The dose administered on 18Sep2024/ Extra Dose). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 18-SEP-2024 The pharmacist reports the patient came into pharmacy requesting RSV vaccine. After the pharmacist administered Arexvy, she found out the patient had actually already had an Arexvy vaccine, which led extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Recived extra dose of shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2021) and Shingrix (received 2nd dose in December 2021). Concomitant products included Influenza vaccine (Flu vaccine VII).   On 01-OCT-2024, the patient received the 3rd dose of Shingrix. On 01-OCT-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Recived extra dose of shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-OCT-2024 The patient self-reported this case. The patient went to get her Flu vaccine that day (on the reporting day) and was asked if she wanted to get the Shingles vaccine as well.   Since the patient could not remember if she already had the Shingrix vaccine, she received the Shingrix vaccine too.   The pharmacist did not saw the vaccination history in the pharmacy or the database. When the patient got home she looked back on old calendars and believed she did received both doses of Shingrix in 2021. The patient was going to contact the pharmacy where she got the Shingrix vaccine in 2021. The patient also got a Flu Vaccine (manufacturer not specified) at the same time. The patient received 3rd dose of Shingrix vaccine, which led to extra dose administered.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 2nd dose today by mistake; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number AN389, expiry date 12-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received first dose of Arexvy in last year).   On 01-OCT-2024, the patient received the 2nd dose of Arexvy. On 01-OCT-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 2nd dose today by mistake). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 01-OCT-2024 The pharmacist reported that the patient received an Arexvy dose last year and just got a 2nd dose on the day of reporting by mistake which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 38.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: had a patient, who was pregnant of about 33 weeks; patient was 38 YO; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number F59KR, expiry date 22-FEB-2025) for prophylaxis.   On 03-OCT-2024 09:00, the patient received Arexvy. On 03-OCT-2024 09:00, an unknown time after receiving Arexvy, the patient experienced product use in unapproved population (Verbatim: patient was 38 YO). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: had a patient, who was pregnant of about 33 weeks). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 33 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 03-OCT-2024 The other health professional reported that they had a patient, who was pregnant of about 33 weeks, visited their office, and the recommendation of her Obstetrics and genecology for a RSV vaccination, and they did administer the GlaxoSmithKline vaccination, because they were not clear on the guidelines for pregnancy, since it look alike that they only recommended Pfizer at this time.  The other health professional reported that they wanted to know more about how may affect the patient, what the patient should expected and if there was any follow up of needed for the patient". The Vaccine Administration Facility was the same as Primary Reporter. The other health professional mentioned that the patient was 38 year old which led to product use in unapproved population, they didn't provide the due date.