chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: UNK
Symptoms: Feeling abnormal, Headache, Influenza like illness, Nausea, Pain
Clinical narrative: Headache; Feeling bad; Patient arm hurts; Slightly nauseous; Patient body aches; Patient had bad reaction; Patient felt like patient was actually with flu; This spontaneous case  initially received on 31-Oct-2024, was reported by a non-health professional and concerns a male patient.  Administration of company suspect drug: On 30-Oct-2024, the patient received Flucelvax (TIV) for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of administration: Not reported. Lot number: No batch number available and will be requested, upon follow-up  No additional suspect drugs.  Adverse reactions/events and outcomes: On 30-Oct-2024, the patient experienced Headache (outcome: Unknown), Feeling bad (outcome: Unknown), Patient arm hurts (outcome: Unknown), Slightly nauseous (outcome: Unknown), Patient body aches (outcome: Unknown), Patient had bad reaction (outcome: Not Reported), Patient felt like patient was actually with flu (outcome: Not Reported).  Patient took Flucelvax on 30-Oct-2024. Patient had a bad reaction. Patient don't what was in that flu shot, but patient said he would never take it again. Patient started feeling bad, body aches, arm hurts, headache. Patient said felt like was actually with flu. Currently patient was feeling better, slightly nauseous and still feeling a little bit off.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide the causality and seriousness of the events ; Reporter's Comments: All Events were considered as related.
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Headache; Feeling bad; Patient arm hurts; Slightly nauseous; Patient body aches; Patient had bad reaction; Patient felt like patient was actually with flu; This spontaneous case  initially received on 31-Oct-2024, was reported by a non-health professional and concerns a male patient.  Administration of company suspect drug: On 30-Oct-2024, the patient received Flucelvax (TIV) for active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of administration: Not reported. Lot number: No batch number available and will be requested, upon follow-up  No additional suspect drugs.  Adverse reactions/events and outcomes: On 30-Oct-2024, the patient experienced Headache (outcome: Unknown), Feeling bad (outcome: Unknown), Patient arm hurts (outcome: Unknown), Slightly nauseous (outcome: Unknown), Patient body aches (outcome: Unknown), Patient had bad reaction (outcome: Not Reported), Patient felt like patient was actually with flu (outcome: Not Reported).  Patient took Flucelvax on 30-Oct-2024. Patient had a bad reaction. Patient don't what was in that flu shot, but patient said he would never take it again. Patient started feeling bad, body aches, arm hurts, headache. Patient said felt like was actually with flu. Currently patient was feeling better, slightly nauseous and still feeling a little bit off.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment: The reporter did not provide the causality and seriousness of the events ; Reporter's Comments: All Events were considered as related.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Confusional state, Flushing, Hyperhidrosis, Loss of consciousness, Mydriasis
Clinical narrative: Unresponsive to stimuli; Loss of consciousness; Seizure; Syncope; Flushing; Hyperhidrosis; Mydriasis; Nausea; confusional state; This spontaneous case, initially received on 05-Nov-2024, was reported by a non-health professional and concerns an adult female patient.  At the time of the event the patient had Syncopy After vaccines.  Administration of company suspect drug(s): On 20-Sep-2024, the patient received Flucelvax (TIV) for Influenza immunization, Dose regimen: .5 ml, Lot number: No batch number available, route of administration and Lot number will be requested upon follow-up.  On 20-Sep-2024, the patient received Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)) Lot number: 6024MF012, dosage, route of administration: intramuscular. Adverse reactions/events and outcomes: On 20-Sep-2024, the patient experienced Unresponsive to stimuli (Medically Significant, outcome: Recovered / Resolved, stop date: 20-Sep-2024), Loss of consciousness (Medically Significant, outcome: Recovered / Resolved, stop date: 20-Sep-2024), Seizure (Medically Significant, outcome: Recovered / Resolved, stop date: 20-Sep-2024), Syncope (Medically Significant, outcome: Recovered / Resolved, stop date: 20-Sep-2024), Flushing (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Hyperhidrosis (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Mydriasis (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Nausea (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Confusional state outcome: Recovered / Resolved, stop date: 20-Sep-2024),    Flucelvax (TIV) action taken: Not Applicable  Reported assessment: The reporter considered the event Loss of consciousness, Seizure, Syncope and Unresponsive to stimuli as serious (Medically significant) and causality was not provided.  The reported considered the event Flushing, Hyperhidrosis, Mydriasis, Confusional state and Nausea as non-serious and causality was not provided.; Reporter's Comments: Causality: Related for events due to close temporal relationship (on the day of vaccine administration). Covid-19 vaccine given on the same day considered as confounder.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Unresponsive to stimuli; Loss of consciousness; Seizure; Syncope; Flushing; Hyperhidrosis; Mydriasis; Nausea; confusional state; This spontaneous case, initially received on 05-Nov-2024, was reported by a non-health professional and concerns an adult female patient.  At the time of the event the patient had Syncopy After vaccines.  Administration of company suspect drug(s): On 20-Sep-2024, the patient received Flucelvax (TIV) for Influenza immunization, Dose regimen: .5 ml, Lot number: No batch number available, route of administration and Lot number will be requested upon follow-up.  On 20-Sep-2024, the patient received Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)) Lot number: 6024MF012, dosage, route of administration: intramuscular. Adverse reactions/events and outcomes: On 20-Sep-2024, the patient experienced Unresponsive to stimuli (Medically Significant, outcome: Recovered / Resolved, stop date: 20-Sep-2024), Loss of consciousness (Medically Significant, outcome: Recovered / Resolved, stop date: 20-Sep-2024), Seizure (Medically Significant, outcome: Recovered / Resolved, stop date: 20-Sep-2024), Syncope (Medically Significant, outcome: Recovered / Resolved, stop date: 20-Sep-2024), Flushing (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Hyperhidrosis (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Mydriasis (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Nausea (outcome: Recovered / Resolved, stop date: 20-Sep-2024), Confusional state outcome: Recovered / Resolved, stop date: 20-Sep-2024),    Flucelvax (TIV) action taken: Not Applicable  Reported assessment: The reporter considered the event Loss of consciousness, Seizure, Syncope and Unresponsive to stimuli as serious (Medically significant) and causality was not provided.  The reported considered the event Flushing, Hyperhidrosis, Mydriasis, Confusional state and Nausea as non-serious and causality was not provided.; Reporter's Comments: Causality: Related for events due to close temporal relationship (on the day of vaccine administration). Covid-19 vaccine given on the same day considered as confounder.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Ear discomfort, Ear infection, Otitis media acute
Clinical narrative: Ear ache/blockage, diagnosed as ear infection  by clinic  Acute suppurative otitis media of right ear without spontaneous rupture of tympanic membrane. 7 day course of amoxicillin
Age: 61.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pharyngeal disorder
Clinical narrative: I?m not sure if my throat issues are related to the vaccine.
Age: 30.0
Sex: M
Vaccine: HPV9
Symptoms: Fall
Clinical narrative: After injection, as I turned to dispose of sharp, patient fell out of chair onto floor, he was verbalize that he was okay  within a few seconds and stated that he had not been ill. Advised to sit still in chair until ambulance arrived. EMS checked patient out, he refused to go with them, signed a AMA waiver and left under his own propulsion ambulatory smiling stating no pain and thanking staff for his help
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Eye irritation
Clinical narrative: Eye irritation left eye. No treatment because it was viral
Age: 1.0
Sex: M
Vaccine: FLU3, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MMR, Varicella, Flulaval, and Pnuemococcal vaccines were ordered for patient.  Instead of administering MMR, MA administered proquad in addition to varicella, flulaval, and pneumococcal vaccines.  Mistake was discovered after administration and after patient left clinic.
Age: 34.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Asthenia, Chills, Cough, Hot flush
Clinical narrative: Fever,  chills, hot flashes, sore joint,  coughing,  low energy for at least 4 days.
Age: 34.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: Fever,  chills, hot flashes, sore joint,  coughing,  low energy for at least 4 days.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: Day after vaccination: after 1.2  mile normal walk was short of breath so checked heart rate  - up over 100  for 30 minutes while sitting. Walked home - again short of breath, checked heart rate (on Smart watch), spiked to 128, never dropped below 115. After walk, headache, took ibuprofen, laid down slept 30 mins.  Heart rate 85 on waking - normal resting hr is 60-63.  Took BP, 135/73. Hr Spiked to 128 early evening when I was passenger in the car - continued high all during dinner with friends. Next morning resting hr logged on smart watch 67 - little high for me but close enough to normal.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Injection site erythema, Pain in extremity
Clinical narrative: Extreme fatigue, fever, chills, have to stay in bed for at least 2 days. Left arm sore, and red patch nearby like a small rash size of a lemon. I just take some water and get up to go to the bathroom, do not eat or drink much, just sleep.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, fever, chills, have to stay in bed for at least 2 days. Left arm sore, and red patch nearby like a small rash size of a lemon. I just take some water and get up to go to the bathroom, do not eat or drink much, just sleep.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inadvertently administered quadracel to patient who is older than 6 years old. Age at time is 7 years old.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, Condition aggravated, Fatigue, Heart rate increased, Somnolence
Clinical narrative: vaccines were on Saturday, 11/02/2014, Sunday I was very tired and slept most of the day, Monday night I started having Afib symptoms at 10:00pm until 3:00am, then was able to sleep.  During the day Tuesday thru Wednesday I had a regular but High heart rate, first in the 90 bpm, then gradually down to normal by end of day Wednesday
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Large, local injection site reaction (approx. 5x5cm) that was raised, erythematous and hot to touch x 4 days. Now devolving to hives and very itchy but appears to be resolving. Also experienced ~72 hours of severe fatigue.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth
Clinical narrative: Large, local injection site reaction (approx. 5x5cm) that was raised, erythematous and hot to touch x 4 days. Now devolving to hives and very itchy but appears to be resolving. Also experienced ~72 hours of severe fatigue.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Mobility decreased, Pain in extremity
Clinical narrative: Patient received influenza vaccine on 10/31/2024. He stated that his arm has been extremely sore and that he has limited mobility in his left arm. He states that he cannot raise it above shoulder height. This started the day after he received the vaccine and  has continued through today. He is going to give this a few more days. I encouraged him to see his provider if this continues. I will continue to follow up with him.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Angina pectoris, Chest X-ray, Electrocardiogram normal
Clinical narrative: 18:00 11/20/2024.  PATIENT CALLED AND SPOKE WITH RPH. SHE SAID THAT SHE GOT A TDAP SHOT ON SUNDAY (11/17/2024), AND THAT SHE HAD FELT "HEART PAINS" SINCE SUNDAY.  SHE WONDERED IF THIS WAS A NORMAL ADVERSE REACTION.  RPH SAID, "IT IS RARE.  THE LITERATURE SAYS THAT MYOCARDITIS IS A POST-MARKETING EVENT, AND THAT NO PERCENTAGE OF FREQUENCY WAS GIVEN".  HE TOLD THE PATIENT THAT SHE "SHOULD CONSULT HER DOCTOR AS SOON AS POSSIBLE".  SHE TOLD RPH THAT SHE "ALREADY DID, AND HER EKG WAS FINE, BUT SHE WAS STILL WAITING ON THE RESULTS OF A CHEST X-RAY".
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Oropharyngeal pain
Clinical narrative: Pain and bruising at injection site; sore throat
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic, Urticaria
Clinical narrative: I broke out into a widespread, itchy rash all over my body. The rash had clusters of hives and raised bumps. I am now on day 6 of the rash and it is not going away. I have seen my dermatologist (Dr. of The Dermatology Group and Dr.  of for consult). Dr. put me on Triamcinolone 0.1% ointment twice a day for a week and then once a day for a week after that. She also advised me to take a Zyrtec each morning and a Benadryl each evening. The rash is very predominant in my armpits, and under my breasts but each day it slowly moves around to add additional areas.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The patient reported to me 11/14/24 that she had trouble with her arm after vaccination. The arm was sore and had trouble lifting her arm. She did message her doctor who replied this is common and to give it time. She said it is slowly getting better but wanted to let me know.  She also consulted with her daughter who is a physician. At the time she reported to me it was improving but slowly
Age: 7.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Rash on both arms, both legs, belly, buttocks, neck, ears, feet
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Exposure during pregnancy, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Low grade fever, runny nose, cough. Itchy redness & swelling at injection site. 35 weeks pregnant.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Low grade fever, runny nose, cough. Itchy redness & swelling at injection site. 35 weeks pregnant.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Pt reported no adverse effects, but she was given a vaccine that was 4 days beyond its BUD of 60 days in the refrigerator.
Age: 62.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Bell's palsy
Clinical narrative: Bell?s palsy
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Product storage error
Clinical narrative: We administered this covid vaccine 4 days beyond its BUD of 60 days in the refrigerator. pt reported having headache and chills that quickly resolved, but she normally has these side effects from vaccines.
Age: 50.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Feeling hot, Pain in extremity
Clinical narrative: Woke up weak and leg pain; Then around 9am, I started feeling more weak and chills. At around 6pm, I felt really hot. Thermometer read 100.4 and took 2 Tylenol Extra Strentgh
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test, Respiratory syncytial virus test, SARS-CoV-2 test
Clinical narrative: I have been diagnosed with influenza A with really severe symptoms. I am an otherwise healthy female, no chronic conditions. I receive the flu shot every year and have never been diagnosed with the flu. I am concerned the vaccine I received may not have been handled or stored properly, leading to an ineffective vaccine
Age: 36.0
Sex: M
Vaccine: COVID19, FLU3, HPV9
Symptoms: Nasopharyngitis, Rash
Clinical narrative: Rashes occur at evening on arms, neck and torso. Taking h1 & h2 antihistimines, will take Mast Cell Mediators Urine test to rule out MCAS. Occured before with Moderna vaccine in 2021 after 3rd Dose but had not occured since
Age: 50.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood test, Chest X-ray, Dyspnoea, Wheezing
Clinical narrative: Wheezing and shortness of breath symptoms, self checked into emergency room (approximately 3.5 hours), treated with prednisone and albuterol, discharged and prescribed 3-day dose of prednisone and albuterol inhaler, follow-up with primary care pending
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: HEADACHE, FEVER, STOMACH ACHE, and REDNESS,SWELLING OF LEFT ARM DOWN TO ELBOW
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chest discomfort, Chills, Cough, Dyspnoea, Headache
Clinical narrative: Shortness of breath, chest tightness, sore throat, chills, cough, runny nose, sneezing, headache low fever, body pain/aches. No treatment received for any symptoms. Symptoms began Sunday 17, November 2024
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Influenza virus test negative, Oropharyngeal pain, Pain, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Shortness of breath, chest tightness, sore throat, chills, cough, runny nose, sneezing, headache low fever, body pain/aches. No treatment received for any symptoms. Symptoms began Sunday 17, November 2024
Age: 26.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Sneezing
Clinical narrative: Shortness of breath, chest tightness, sore throat, chills, cough, runny nose, sneezing, headache low fever, body pain/aches. No treatment received for any symptoms. Symptoms began Sunday 17, November 2024
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Electromyogram, Erythema, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Symptoms from the reaction were pretty immediate my should got red and hot the circle got to the size of a softball. As I had had frozen shoulder from a bad shot previously i immediately started ibuprofen and icing the site. I called the the pharmacy and asked if normal or should call doctor. They said to circle with pen and it got any bigger or over the shoulder joint to call Dr. it quit creeping but took over 2 weeks for the redness to subside, but the soreness never went away and I kept moving it, in fear of repeat performance of pain that I had had in my right shoulder.  It just kept getting more lawn down my shoulder into my hands and fingers, was unable to push up out of a chair with it, numbness in fingers and then in May unable to move my arm back to hook my bra. Saw my personal Dr who did X-rays, then sent to pt to see it get improvement-6 weeks later or so  at follow up sent to orthopedic  and neck and arm mris, given medication for pain and inflammation
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Inflammation, Magnetic resonance imaging, Magnetic resonance imaging neck, Mobility decreased, Skin warm
Clinical narrative: Symptoms from the reaction were pretty immediate my should got red and hot the circle got to the size of a softball. As I had had frozen shoulder from a bad shot previously i immediately started ibuprofen and icing the site. I called the the pharmacy and asked if normal or should call doctor. They said to circle with pen and it got any bigger or over the shoulder joint to call Dr. it quit creeping but took over 2 weeks for the redness to subside, but the soreness never went away and I kept moving it, in fear of repeat performance of pain that I had had in my right shoulder.  It just kept getting more lawn down my shoulder into my hands and fingers, was unable to push up out of a chair with it, numbness in fingers and then in May unable to move my arm back to hook my bra. Saw my personal Dr who did X-rays, then sent to pt to see it get improvement-6 weeks later or so  at follow up sent to orthopedic  and neck and arm mris, given medication for pain and inflammation
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Spinal X-ray, X-ray limb
Clinical narrative: Symptoms from the reaction were pretty immediate my should got red and hot the circle got to the size of a softball. As I had had frozen shoulder from a bad shot previously i immediately started ibuprofen and icing the site. I called the the pharmacy and asked if normal or should call doctor. They said to circle with pen and it got any bigger or over the shoulder joint to call Dr. it quit creeping but took over 2 weeks for the redness to subside, but the soreness never went away and I kept moving it, in fear of repeat performance of pain that I had had in my right shoulder.  It just kept getting more lawn down my shoulder into my hands and fingers, was unable to push up out of a chair with it, numbness in fingers and then in May unable to move my arm back to hook my bra. Saw my personal Dr who did X-rays, then sent to pt to see it get improvement-6 weeks later or so  at follow up sent to orthopedic  and neck and arm mris, given medication for pain and inflammation
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: pt complaint feeling some mouth tingling. Pt has no signs of shortness of breath, no hives, no cough, slight itchy on left should(where the shot was administered) but itchy was gone after 1.5 hours observation.  Pt was offered but declined to have EMT, MD, husband called. She said she can drive home and take Benadryl  if needed.  She left without signs of complications. Pt stayed she was ok at home after our phone call check 2 hrs later.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Perioral dermatitis, Pruritus, Pyrexia, Rash
Clinical narrative: The patient developed 104 degrees F fever on 11/15/2024 in the evening. She also had red, bumpy lesions around her perioral region and frontal neck. Saturday, the lesions started to blister & crust. The lesions spread to her abdomen and upper extremities Saturday. They were itchy, red, crusty and slightly blistered. New rash on 11/19/24 in diaper area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash erythematous, Scab, Skin lesion
Clinical narrative: The patient developed 104 degrees F fever on 11/15/2024 in the evening. She also had red, bumpy lesions around her perioral region and frontal neck. Saturday, the lesions started to blister & crust. The lesions spread to her abdomen and upper extremities Saturday. They were itchy, red, crusty and slightly blistered. New rash on 11/19/24 in diaper area.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: administration to pregnant patients; administration to pregnant patients; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of drug exposure during pregnancy 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 drug exposure during pregnancy (Verbatim: administration to pregnant patients) and product use in unapproved population (Verbatim: administration to pregnant patients). The outcome of the drug exposure during pregnancy and product use in unapproved population were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 30-OCT-2024 The reporter called inquiring if Arexvy was safe for pregnant woman.  The office was giving it to pregnant patient.  The reporter stated that there was pregnant patient who received Arexvy recently, which led to vaccine exposure during pregnancy and product use in unapproved population. The reporter had no additional information but would ask nurse practitioner to call with more details.   No lot/expiration date were available.  No patient details were available.  No dates of administration were available. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024134993:patient 1 US-GSK-US2024AMR142776:Patient 2
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperhidrosis, Injection site erythema, Pustule, Rash
Clinical narrative: Covid pustulosis/ Pustules on my face, my neck, my chest, my arm and I have them on my parts of my legs and my trunk; Red welts that morphed into a welt with a pustule on the top of it; It did not go away; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 at 12:00 as dose 1, 0.3 ml single (Lot number: LM2215) intramuscular, in right arm for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), from 05Sep2024 (Lot number: X357E) to 05Sep2024 at 0.5 mL single (dose number unknown, 0.5ml single) for immunisation. The patient's relevant medical history included: "Chronic UTI" (ongoing), notes: Chronic UTI. Concomitant medication(s) included: METHENAMINE HIPPURATE taken for urinary tract infection; D-MANNOSE. The following information was reported: PUSTULE (non-serious) with onset Sep2024, outcome "unknown", described as "Covid pustulosis/ Pustules on my face, my neck, my chest, my arm and I have them on my parts of my legs and my trunk"; URTICARIA (non-serious) with onset Sep2024, outcome "unknown", described as "Red welts that morphed into a welt with a pustule on the top of it; It did not go away".  Additional information: The consumer stated, who received the most recent COVID-19 vaccine on 05Sep2024 at noon 12:00 PM. Within two days, she developed red welts that eventually turned into pustules. After a few days, they didn't go away. Now, she had pustules on her face, neck, chest, arm, legs, and trunk. It's concerning, and it's also making her feel self-conscious because it looks terrible. She was trying to figure out what to do about it. She was not sure if she reported this as an adverse event before, but she was confused as to why no one has followed up with me. It's uncomfortable, and she really want to know what can be done to get rid of these welts and pustules. She was hoping someone can help figure this out.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pustule, Urticaria
Clinical narrative: Covid pustulosis/ Pustules on my face, my neck, my chest, my arm and I have them on my parts of my legs and my trunk; Red welts that morphed into a welt with a pustule on the top of it; It did not go away; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Sep2024 at 12:00 as dose 1, 0.3 ml single (Lot number: LM2215) intramuscular, in right arm for covid-19 immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX), from 05Sep2024 (Lot number: X357E) to 05Sep2024 at 0.5 mL single (dose number unknown, 0.5ml single) for immunisation. The patient's relevant medical history included: "Chronic UTI" (ongoing), notes: Chronic UTI. Concomitant medication(s) included: METHENAMINE HIPPURATE taken for urinary tract infection; D-MANNOSE. The following information was reported: PUSTULE (non-serious) with onset Sep2024, outcome "unknown", described as "Covid pustulosis/ Pustules on my face, my neck, my chest, my arm and I have them on my parts of my legs and my trunk"; URTICARIA (non-serious) with onset Sep2024, outcome "unknown", described as "Red welts that morphed into a welt with a pustule on the top of it; It did not go away".  Additional information: The consumer stated, who received the most recent COVID-19 vaccine on 05Sep2024 at noon 12:00 PM. Within two days, she developed red welts that eventually turned into pustules. After a few days, they didn't go away. Now, she had pustules on her face, neck, chest, arm, legs, and trunk. It's concerning, and it's also making her feel self-conscious because it looks terrible. She was trying to figure out what to do about it. She was not sure if she reported this as an adverse event before, but she was confused as to why no one has followed up with me. It's uncomfortable, and she really want to know what can be done to get rid of these welts and pustules. She was hoping someone can help figure this out.
Age: 79.0
Sex: F
Vaccine: FLU3, RSV, UNK
Symptoms: Cerebrovascular accident
Clinical narrative: acute CVA within 4 hours after administration of FLUBLOK; right sided weakness; Initial information received on 12-Nov-2024 regarding an unsolicited valid serious case received from an other health professional.  This case involves a 79 years old female patient who experienced acute cva (Cerebrovascular accident) within 4 hours after administration of Influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RSV vaccine prot. subunit PreF3 (Arexvy).  On 22-Oct-2024, the patient received 0.5 ml dose of suspect Influenza trivalent recombinant vaccine Solution for injection (Strength- standard) (Frequency- once) (lot- BL473 and expiration date- 13-OCT-2026) via intramuscular route in the left deltoid for Immunisation.  On 22-Oct-2024, the patient developed acute cva within 4 hours after administration of flublok (cerebrovascular accident) (latency- 4 hours) and right sided weakness (asthenia) (latency- same day).   Relevant laboratory test results included: Magnetic resonance imaging head - On an unknown date: [stroke] Echocardiogram:  Negative  Reportedly, Denies any numbness, tingling, headache or sensory changes.  Action taken- not applicable.  The patient was treated with Acetylsalicylic acid (Aspirin), clopidogrel bisulfate (plavix) and Atorvastatin calcium (Atorvastatin) for Symptomatic treatment.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events  Seriousness criteria- Medically significant for cerebrovascular accident.; Sender's Comments: Sanofi Company Comment dated 20-Nov-2024: This case involves a 79 years old female patient who experienced acute cva (Cerebrovascular accident) within 4 hours after administration of Influenza trivalent recombinant vaccine [Flublok TIV]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 79.0
Sex: F
Vaccine: FLU3, RSV, UNK
Symptoms: Arteriogram carotid, Cerebrovascular accident, Echocardiogram normal, Hemiparesis, Magnetic resonance imaging head abnormal
Clinical narrative: acute CVA within 4 hours after administration of FLUBLOK; right sided weakness; Initial information received on 12-Nov-2024 regarding an unsolicited valid serious case received from an other health professional.  This case involves a 79 years old female patient who experienced acute cva (Cerebrovascular accident) within 4 hours after administration of Influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RSV vaccine prot. subunit PreF3 (Arexvy).  On 22-Oct-2024, the patient received 0.5 ml dose of suspect Influenza trivalent recombinant vaccine Solution for injection (Strength- standard) (Frequency- once) (lot- BL473 and expiration date- 13-OCT-2026) via intramuscular route in the left deltoid for Immunisation.  On 22-Oct-2024, the patient developed acute cva within 4 hours after administration of flublok (cerebrovascular accident) (latency- 4 hours) and right sided weakness (asthenia) (latency- same day).   Relevant laboratory test results included: Magnetic resonance imaging head - On an unknown date: [stroke] Echocardiogram:  Negative  Reportedly, Denies any numbness, tingling, headache or sensory changes.  Action taken- not applicable.  The patient was treated with Acetylsalicylic acid (Aspirin), clopidogrel bisulfate (plavix) and Atorvastatin calcium (Atorvastatin) for Symptomatic treatment.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events  Seriousness criteria- Medically significant for cerebrovascular accident.; Sender's Comments: Sanofi Company Comment dated 20-Nov-2024: This case involves a 79 years old female patient who experienced acute cva (Cerebrovascular accident) within 4 hours after administration of Influenza trivalent recombinant vaccine [Flublok TIV]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 79.0
Sex: F
Vaccine: FLU3, RSV, UNK
Symptoms: Scan with contrast abnormal
Clinical narrative: acute CVA within 4 hours after administration of FLUBLOK; right sided weakness; Initial information received on 12-Nov-2024 regarding an unsolicited valid serious case received from an other health professional.  This case involves a 79 years old female patient who experienced acute cva (Cerebrovascular accident) within 4 hours after administration of Influenza trivalent recombinant vaccine [Flublok TIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RSV vaccine prot. subunit PreF3 (Arexvy).  On 22-Oct-2024, the patient received 0.5 ml dose of suspect Influenza trivalent recombinant vaccine Solution for injection (Strength- standard) (Frequency- once) (lot- BL473 and expiration date- 13-OCT-2026) via intramuscular route in the left deltoid for Immunisation.  On 22-Oct-2024, the patient developed acute cva within 4 hours after administration of flublok (cerebrovascular accident) (latency- 4 hours) and right sided weakness (asthenia) (latency- same day).   Relevant laboratory test results included: Magnetic resonance imaging head - On an unknown date: [stroke] Echocardiogram:  Negative  Reportedly, Denies any numbness, tingling, headache or sensory changes.  Action taken- not applicable.  The patient was treated with Acetylsalicylic acid (Aspirin), clopidogrel bisulfate (plavix) and Atorvastatin calcium (Atorvastatin) for Symptomatic treatment.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events  Seriousness criteria- Medically significant for cerebrovascular accident.; Sender's Comments: Sanofi Company Comment dated 20-Nov-2024: This case involves a 79 years old female patient who experienced acute cva (Cerebrovascular accident) within 4 hours after administration of Influenza trivalent recombinant vaccine [Flublok TIV]. The causal role of the company suspect vaccine cannot be assessed based on the temporal relevance. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Age: 74.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Deafness
Clinical narrative: Throwing up; Nauseous; Couldn't walk; Almost fainted; Labyrinthitis; It feels like my ear needs to pop / Pressure in my ear; Anxious; Lost hearing in my right ear; This spontaneous case, initially received on 10-Nov-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had COPD, asthma, emphysema.  Concomitant medication: refer to appropriate report section, in addition to blood pressure medicine, water pill and natural honey.  Administration of company suspect drug(s): On 21-Oct-2024, the patient received Fluad (TIV) for Prevent flu., Dosage: Not reported, Route of administration: Not reported, Site of administration: Not reported, Lot number: Not reported and requested upon follow-up..  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Oct-2024, the patient experienced Lost hearing in my right ear (Medically Significant, outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Almost fainted (outcome: Not recovered / Not resolved), Anxious (outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Labyrinthitis (outcome: Not recovered / Not resolved). Associated symptoms included: Throwing up, Nauseous, Couldn't walk, It feels like my ear needs to pop / Pressure in my ear.  The reporter stated that on 21-Oct-2024, got a flu shot. The next morning, he had lost hearing in his right ear, was throwing up, nauseous, and couldn't walk. His daughter (a nurse practitioner) got him some anti nausea medicine and some dizziness medicine. The patient had seen ear, nose, and throat (ENT) and had a MRI, blood tests, prednisone, amoxicillin, and 2 shots into his ear of prednisone or something. Nothing had changed. After the ear injection, he couldn't swallow for 15 minutes. He almost fainted. It felt like his ear needed to pop. He had had an ear test and they said it was very bad. They said it was labyrinthitis. His physician had heard of other people with this. It was pressure in hi ear. It made him sometimes anxious and it was overwhelming. The ear, nose, and throat said a hearing aid or cochlear implants wouldn't help.  Fluad (TIV) action taken: Not Applicable Treatment medication: Amoxicillin   , Prednisone, unspecified anti nausea medicine and unspecified dizziness medicine.  Reporter's assessment: The reporter provided the seriousness assessment as unknown but did not provide a causality assessment.; Reporter's Comments: Causality: Related for Presyncope, due to plausible temporal association of next day of vaccination and biological plausibility. Unassessable, for deafness unilateral, labyrinthitis, anxiety. The information provided is insufficient to perform a more in-depth analysis (history of concurrent infections, risk factors, lab reports are not available)
Age: 74.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Anxiety, Blood test, Deafness unilateral, Ear discomfort, Gait inability
Clinical narrative: Throwing up; Nauseous; Couldn't walk; Almost fainted; Labyrinthitis; It feels like my ear needs to pop / Pressure in my ear; Anxious; Lost hearing in my right ear; This spontaneous case, initially received on 10-Nov-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had COPD, asthma, emphysema.  Concomitant medication: refer to appropriate report section, in addition to blood pressure medicine, water pill and natural honey.  Administration of company suspect drug(s): On 21-Oct-2024, the patient received Fluad (TIV) for Prevent flu., Dosage: Not reported, Route of administration: Not reported, Site of administration: Not reported, Lot number: Not reported and requested upon follow-up..  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Oct-2024, the patient experienced Lost hearing in my right ear (Medically Significant, outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Almost fainted (outcome: Not recovered / Not resolved), Anxious (outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Labyrinthitis (outcome: Not recovered / Not resolved). Associated symptoms included: Throwing up, Nauseous, Couldn't walk, It feels like my ear needs to pop / Pressure in my ear.  The reporter stated that on 21-Oct-2024, got a flu shot. The next morning, he had lost hearing in his right ear, was throwing up, nauseous, and couldn't walk. His daughter (a nurse practitioner) got him some anti nausea medicine and some dizziness medicine. The patient had seen ear, nose, and throat (ENT) and had a MRI, blood tests, prednisone, amoxicillin, and 2 shots into his ear of prednisone or something. Nothing had changed. After the ear injection, he couldn't swallow for 15 minutes. He almost fainted. It felt like his ear needed to pop. He had had an ear test and they said it was very bad. They said it was labyrinthitis. His physician had heard of other people with this. It was pressure in hi ear. It made him sometimes anxious and it was overwhelming. The ear, nose, and throat said a hearing aid or cochlear implants wouldn't help.  Fluad (TIV) action taken: Not Applicable Treatment medication: Amoxicillin   , Prednisone, unspecified anti nausea medicine and unspecified dizziness medicine.  Reporter's assessment: The reporter provided the seriousness assessment as unknown but did not provide a causality assessment.; Reporter's Comments: Causality: Related for Presyncope, due to plausible temporal association of next day of vaccination and biological plausibility. Unassessable, for deafness unilateral, labyrinthitis, anxiety. The information provided is insufficient to perform a more in-depth analysis (history of concurrent infections, risk factors, lab reports are not available)
Age: 74.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Laboratory test abnormal, Labyrinthitis, Magnetic resonance imaging head, Nausea, Presyncope
Clinical narrative: Throwing up; Nauseous; Couldn't walk; Almost fainted; Labyrinthitis; It feels like my ear needs to pop / Pressure in my ear; Anxious; Lost hearing in my right ear; This spontaneous case, initially received on 10-Nov-2024, was reported by a non health professional and concerns an elderly male patient.  At the time of the event the patient had COPD, asthma, emphysema.  Concomitant medication: refer to appropriate report section, in addition to blood pressure medicine, water pill and natural honey.  Administration of company suspect drug(s): On 21-Oct-2024, the patient received Fluad (TIV) for Prevent flu., Dosage: Not reported, Route of administration: Not reported, Site of administration: Not reported, Lot number: Not reported and requested upon follow-up..  No additional suspect drugs.  Adverse reactions/events and outcomes: On 22-Oct-2024, the patient experienced Lost hearing in my right ear (Medically Significant, outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Almost fainted (outcome: Not recovered / Not resolved), Anxious (outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Labyrinthitis (outcome: Not recovered / Not resolved). Associated symptoms included: Throwing up, Nauseous, Couldn't walk, It feels like my ear needs to pop / Pressure in my ear.  The reporter stated that on 21-Oct-2024, got a flu shot. The next morning, he had lost hearing in his right ear, was throwing up, nauseous, and couldn't walk. His daughter (a nurse practitioner) got him some anti nausea medicine and some dizziness medicine. The patient had seen ear, nose, and throat (ENT) and had a MRI, blood tests, prednisone, amoxicillin, and 2 shots into his ear of prednisone or something. Nothing had changed. After the ear injection, he couldn't swallow for 15 minutes. He almost fainted. It felt like his ear needed to pop. He had had an ear test and they said it was very bad. They said it was labyrinthitis. His physician had heard of other people with this. It was pressure in hi ear. It made him sometimes anxious and it was overwhelming. The ear, nose, and throat said a hearing aid or cochlear implants wouldn't help.  Fluad (TIV) action taken: Not Applicable Treatment medication: Amoxicillin   , Prednisone, unspecified anti nausea medicine and unspecified dizziness medicine.  Reporter's assessment: The reporter provided the seriousness assessment as unknown but did not provide a causality assessment.; Reporter's Comments: Causality: Related for Presyncope, due to plausible temporal association of next day of vaccination and biological plausibility. Unassessable, for deafness unilateral, labyrinthitis, anxiety. The information provided is insufficient to perform a more in-depth analysis (history of concurrent infections, risk factors, lab reports are not available)