chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, FLUA4, RSV
Symptoms: Product preparation error
Clinical narrative: Patient received the RSV Arexvy vaccine as just the diluent without being mixed with the active antigen component. Patient will schedule an appointment for re-vaccination.
Age: 12.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Dizziness, Paraesthesia, Syncope
Clinical narrative: After the vaccines he fainted and his father caught him preventing him from hitting his head. He regained consciousness in less than a minute and described feeling dizzy before fainting then tingling in his hands.  We had called 911 and upon examination determined all vitals were normal and the patient and his father left.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical Assistant when she was inputting the vaccine information in the patient chart she realized that she gave the 11 yr old patient the Men B instead of the Tdap. She informed the provider and the practice manager, the provider called the mother to informed her of the incident.Patient is doing well with no reaction to the vaccine.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: provided supportive routine care and advised to call  if rash got worse
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Back pain, Chest pain, Chills, Dyspnoea, Ear pain
Clinical narrative: chills, ear ache, back pain, chest pain, hard to breathe
Age: 52.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Diarrhoea, Eye pain, Eye swelling, Glossodynia, Lip pain
Clinical narrative: Patient reported fever for 2 days after getting the vaccines, and also he has had diarrhea, swollen and painful: eyes, tongue, mouth, checks, lips. He has tried tylenol. He is still having symptoms 5 days after vaccine. I suggested benadryl and that he should see a doctor.
Age: 52.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Lip swelling, Mouth swelling, Oral pain, Pyrexia, Swollen tongue
Clinical narrative: Patient reported fever for 2 days after getting the vaccines, and also he has had diarrhea, swollen and painful: eyes, tongue, mouth, checks, lips. He has tried tylenol. He is still having symptoms 5 days after vaccine. I suggested benadryl and that he should see a doctor.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Extreme  fatigue, headache, muscle pain, joint pain, chills, violent nausea and vomiting, fever of 101, and diarrhea. After 2 weeks, I am still not normal
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Extreme  fatigue, headache, muscle pain, joint pain, chills, violent nausea and vomiting, fever of 101, and diarrhea. After 2 weeks, I am still not normal
Age: 20.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Condition aggravated, Eczema, Exposure to communicable disease, Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: I developed shingles at age 21 on October 11th, 2023. I never had chicken pox as a child. I am in school, however I have been under much more stress in my life than I am right now. My immune system may be under stress from being exposed to everything at clinical in the hospital, but I?ve been in school since May 2022. I had a recent infection in the same area as the shingles came to, and right before developing shingles I finished a cycle of cephalosporins and topical triamcinolone at the same site as the shingles. These medications were for an eczema exacerbation that my doctor believed became infected.
Age: 20.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection, Stress
Clinical narrative: I developed shingles at age 21 on October 11th, 2023. I never had chicken pox as a child. I am in school, however I have been under much more stress in my life than I am right now. My immune system may be under stress from being exposed to everything at clinical in the hospital, but I?ve been in school since May 2022. I had a recent infection in the same area as the shingles came to, and right before developing shingles I finished a cycle of cephalosporins and topical triamcinolone at the same site as the shingles. These medications were for an eczema exacerbation that my doctor believed became infected.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Facial pain, Headache, Injection site pain, Temporomandibular joint syndrome, Trismus
Clinical narrative: experiencing pain at injection site, severe headache and lock jaw. TMJ both R and L sides of my jaw, cannot close teeth. Facial pain on left side where the lock jaw began
Age: 51.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Lip swelling
Clinical narrative: SWELLING ON LIPS
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth and swelling at injection site
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Headache, Mobility decreased
Clinical narrative: weakness, joint pain, could not move arms and legs, headache.
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was under 65 years of age (64) and received Fluad approved for patients 65 years of age and older.
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error. This vaccine (approved for those ages 60+) was given to a 59 year old.   Reporting RN was administering vaccines at an offsite vaccine event where COVID, flu and RSV vaccines were being offered. Despite signage at the entrance to the event and announcements made during the event, this patient was not aware that the RSV vaccine was approved for those 60+. Patient visited check-in staff and requested all three vaccines. Patient was checked-in and was handed a prescreening form to fill out.  Check-in staff wrote "COVID+flu+RSV" at the top of this form, indicating that the patient desired to get all three vaccines as was the process.  Patient completed pre-screening form and presented it to this RN. This RN checked prescreening checklist for contraindications, but missed that his birthday was 1 year off- he was 59, not 60. Vaccines administered without incident. Upon charting later, RN noticed the error that had been made.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: redness, warmth, itching at injection site
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Incontinence, Insomnia, Myalgia
Clinical narrative: Thirst, headache, muscle aches, dizziness, incontinence (urination every 20-30 minutes, all night long), insomnia.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Thirst
Clinical narrative: Thirst, headache, muscle aches, dizziness, incontinence (urination every 20-30 minutes, all night long), insomnia.
Age: 0.17
Sex: F
Vaccine: IPV
Symptoms: Extra dose administered, Medication error
Clinical narrative: nurses gave a child 1 vaxelis and 1 ipol shot on the same day with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA341553.  This case involves a 2 months old female patient to whom nurses gave1 vaxelis and 1 ipol shot on the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (Menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (VERO), tetanus vaccine Toxoid (Vaxelis); rotavirus vaccine and pneumococcal vaccine for Prophylactic vaccination.  On 03-Nov-2023, the patient received suspect IPV (VERO), Suspension for injection lot V1B902M expiry date: 02-Jun-2024 via intramuscular route in the right thigh for immunization (strength, dose: unknown).nurses gave 1 vaxelis and 1 ipol shot on the same day with no reported adverse event (extra dose administered) (latency same day).  Action taken: not applicable.  Outcome: unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Balance disorder, Blood glucose, Head injury, Loss of consciousness
Clinical narrative: About 1 minute after receiving her flu shot the patient passed out on the floor.  Briefly loss of  consciousness. Appeared to have bumped head on carpeted floor.  Pt awoke and was complaining of nausea and stomach pain.  We immediatedly called EMS.  Pt sat up and began to dry heave but no vomit came out.  Pt wanted to stand up and use the bathroom.  Her mom and I walked her to the restroom.  She was very wobbly on her feet.  The ambulance came and checked her blood pressure/ heart / blood sugar.  She began to improve while the ambulance technicians were with her.  Mom did not want her to go to the hospital.  She walked out of the store under her own strength.  I checked in with her at 7pm at pt. was fine.  Belive it was a vagal response to vaccine.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Retching
Clinical narrative: About 1 minute after receiving her flu shot the patient passed out on the floor.  Briefly loss of  consciousness. Appeared to have bumped head on carpeted floor.  Pt awoke and was complaining of nausea and stomach pain.  We immediatedly called EMS.  Pt sat up and began to dry heave but no vomit came out.  Pt wanted to stand up and use the bathroom.  Her mom and I walked her to the restroom.  She was very wobbly on her feet.  The ambulance came and checked her blood pressure/ heart / blood sugar.  She began to improve while the ambulance technicians were with her.  Mom did not want her to go to the hospital.  She walked out of the store under her own strength.  I checked in with her at 7pm at pt. was fine.  Belive it was a vagal response to vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alopecia, Alopecia universalis, Biopsy skin abnormal, Blood test normal
Clinical narrative: Alopecia Universalis.    Two months after receiving vaccine, patient experienced extreme hair loss on scalp.  By June 2023, patient was completely bold on scalp and also has complete hair loss on entire body.   Pattern of hair loos - scalp, face and arms, eye brows and lashes, legs and pubic hair.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Flushing, Increased bronchial secretion
Clinical narrative: Became flushed, gurgling, wanted to get ill, O2 Sat range 94- 96, HR 77 , resp unlabored, B/P 141/102. Assistance from other nurses, ER kit Epi at bedside. Layed down, feet up, Amonnia smelt assisted improved color and no vomiting. Airway sounded clear, 0410 Heart rate 81 r, 140/81 lying. o2 Sat 96. Non labored breathing. 4:13 sitting up B/P 140/95 Hr 87 reg. 4:20 pm Sipping on juice, cold h20 Bp136/78, 85 reg , O2 Sat 98. Stated felt more like herself, holding toddler who was also going to get immunized this day. She was wondering if her eyes looked swollen, they did not. Left message with PCP. She will return our call. Pt left at 5:15 with daughter stated feeling like she did before appt. Has a Benedryl at home  and plans to take one at HS. Educated re: ;calling EMS if any symptoms returning and she stated ok an d agreed to f/u by phone later.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Bedridden, Dizziness, Dysuria, Laboratory test
Clinical narrative: She developed sudden weakness and  dizziness. End up admitted  at hospital. She currently is bedbound and her weakness has worsened.  For 2 weeks she has not been able to void.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: B-cell lymphoma, Chemotherapy, Lymphadenectomy, Lymphadenopathy
Clinical narrative: Pt developed cervical lymphadenopathy around 6 months after 2nd Moderna vaccine and was subsequently diagnosed with diffuse large B cell lymphoma. Pt currently in remission after chemotherapy
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: Vaccine vial is suppose to be diluted with 1.1ml 0.9% Sodium chloride prior to drawing up vaccine and administering vaccine. After dilution of vaccine, vial has 3 doses per vial of 3mcg/0.3mL.   Error occurred: MA prepared and administered vaccine without prior dilution of vaccine. Vaccine error was caught  by charge nurse a few hours after vaccine was administered by the MA. Pt's mother and MD was notified, per pt's mother pt is doing fine with no adverse reactions at this time.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Hyperacusis, Migraine
Clinical narrative: daily migraine headaches with aura and visual/auditory sensitivity starting 11/12, gastro upset (lack of appetite, nausea, loose stools), irregular sleep, extreme exhaustion (resolved to excessive but can work from home as of 11/15)
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine with aura, Nausea, Photophobia, Sleep disorder
Clinical narrative: daily migraine headaches with aura and visual/auditory sensitivity starting 11/12, gastro upset (lack of appetite, nausea, loose stools), irregular sleep, extreme exhaustion (resolved to excessive but can work from home as of 11/15)
Age: 62.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Cough, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: I had flu vaccines before - not unusual to feel 'off' for a day, but nothing significant. I decided to add the RSV vaccine this year because I am around my elderly (mid-80's) parents frequently. They are in an assisted living facility, so I am around other elderly people as well.  Boy, do I regret adding the RSV as I am assuming that is what caused the problem. Vaccinated on Thursday, NOV 9 at 3:15 pm.  I could feel the 'typical' flu vaccine reaction by 12 midnight that night. Nothing unusual at this point. Got up the next morning (Friday, NOV 10) to take my car to the dealership for some work.  As I waited for my car (about 2 hours) I began to feel worse and worse - headache, slight fever, body aches, fatigue.  By the time I got home - went straight to bed (12:30 pm or so). Symptoms continued to get worse. So much so that by that evening, I felt like I had a full-on flu infection. Body ache and headache so bad I could not sleep. On Saturday, NOV 11 I spent the entire day in bed, miserable.  Nausea set in so severely that I couldn't stand up without getting extremely nauseous. Threw up the medication and vitamins I take in the evening. Did not eat anything that day as I couldn't stomach the thought of food. Sunday, NOV 12 was more of the same, except now I had sinus/head cold symptoms as well. Sore throat, stuffy nose, coughing. Monday, NOV 13 was tolerable, but once I had what I had to do done, back to bed. Tuesday, Nov 14 the first relatively 'normal' day, however I still had lingering head cold symptoms. I have never lost so much time due to a vaccine nor have I ever felt sick for so long. Today (NOV 16) is really the first day I feel normal. One whole week later.
Age: 62.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Influenza like illness, Nasal congestion, Nasopharyngitis, Nausea, Oropharyngeal pain
Clinical narrative: I had flu vaccines before - not unusual to feel 'off' for a day, but nothing significant. I decided to add the RSV vaccine this year because I am around my elderly (mid-80's) parents frequently. They are in an assisted living facility, so I am around other elderly people as well.  Boy, do I regret adding the RSV as I am assuming that is what caused the problem. Vaccinated on Thursday, NOV 9 at 3:15 pm.  I could feel the 'typical' flu vaccine reaction by 12 midnight that night. Nothing unusual at this point. Got up the next morning (Friday, NOV 10) to take my car to the dealership for some work.  As I waited for my car (about 2 hours) I began to feel worse and worse - headache, slight fever, body aches, fatigue.  By the time I got home - went straight to bed (12:30 pm or so). Symptoms continued to get worse. So much so that by that evening, I felt like I had a full-on flu infection. Body ache and headache so bad I could not sleep. On Saturday, NOV 11 I spent the entire day in bed, miserable.  Nausea set in so severely that I couldn't stand up without getting extremely nauseous. Threw up the medication and vitamins I take in the evening. Did not eat anything that day as I couldn't stomach the thought of food. Sunday, NOV 12 was more of the same, except now I had sinus/head cold symptoms as well. Sore throat, stuffy nose, coughing. Monday, NOV 13 was tolerable, but once I had what I had to do done, back to bed. Tuesday, Nov 14 the first relatively 'normal' day, however I still had lingering head cold symptoms. I have never lost so much time due to a vaccine nor have I ever felt sick for so long. Today (NOV 16) is really the first day I feel normal. One whole week later.
Age: 62.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Pain, Pyrexia, Sinus disorder, Sleep disorder, Vomiting
Clinical narrative: I had flu vaccines before - not unusual to feel 'off' for a day, but nothing significant. I decided to add the RSV vaccine this year because I am around my elderly (mid-80's) parents frequently. They are in an assisted living facility, so I am around other elderly people as well.  Boy, do I regret adding the RSV as I am assuming that is what caused the problem. Vaccinated on Thursday, NOV 9 at 3:15 pm.  I could feel the 'typical' flu vaccine reaction by 12 midnight that night. Nothing unusual at this point. Got up the next morning (Friday, NOV 10) to take my car to the dealership for some work.  As I waited for my car (about 2 hours) I began to feel worse and worse - headache, slight fever, body aches, fatigue.  By the time I got home - went straight to bed (12:30 pm or so). Symptoms continued to get worse. So much so that by that evening, I felt like I had a full-on flu infection. Body ache and headache so bad I could not sleep. On Saturday, NOV 11 I spent the entire day in bed, miserable.  Nausea set in so severely that I couldn't stand up without getting extremely nauseous. Threw up the medication and vitamins I take in the evening. Did not eat anything that day as I couldn't stomach the thought of food. Sunday, NOV 12 was more of the same, except now I had sinus/head cold symptoms as well. Sore throat, stuffy nose, coughing. Monday, NOV 13 was tolerable, but once I had what I had to do done, back to bed. Tuesday, Nov 14 the first relatively 'normal' day, however I still had lingering head cold symptoms. I have never lost so much time due to a vaccine nor have I ever felt sick for so long. Today (NOV 16) is really the first day I feel normal. One whole week later.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Lichen planus, Oral lichen planus, Oral mucosal erythema, Oral pain, Rash
Clinical narrative: Approximately 6 days after receiving my RSV shot I developed what my doctor thinks is Lichen Planus both oral (palate) and dermal (neck).  The top of my mouth has redness around the periphery and is extremely painful, especially when I try to eat, drink, or brush. It feels like it was burned but I don't recall a burn and it hasn't healed in at least 5 days. Simultaneously, I developed a very itchy rash on both sides of my neck.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Rash pruritic
Clinical narrative: Approximately 6 days after receiving my RSV shot I developed what my doctor thinks is Lichen Planus both oral (palate) and dermal (neck).  The top of my mouth has redness around the periphery and is extremely painful, especially when I try to eat, drink, or brush. It feels like it was burned but I don't recall a burn and it hasn't healed in at least 5 days. Simultaneously, I developed a very itchy rash on both sides of my neck.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient came to the pharmacy for Novavax vaccine. Shingrix vaccine accidentally administered.
Age: 10.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Joint hyperextension, Unresponsive to stimuli
Clinical narrative: Student was sitting with head turned towards the right as watching a video on cellphone.  Her father sitting next to student.  Was first given HPV, IM, then varicella, SQ, both on the left arm.  After shots were given,  student turned her head towards center but did not react when name was called and told "all done".   Then, trunk and neck hyperextended for about 1-2 seconds.  After which, student recovered and was fully awake, alert.  There was no cyanosis, skin was warm, no shortness of breath.  Pulse was strong and about 90/min.  Pupils, 3mm, equally reactive to light.   Student remained seated on chair and rested for about 5 mins.  Then got up and walked.  went home with father.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Swelling, Ultrasound neck
Clinical narrative: The patient had marked left submandibular swelling that developed one day before presenting to ER. The patient states he had both a COVID-19 vaccine and an influenza vaccine given to him on 11/10/2023
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red at injection site and itchy
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Skin warm, Swelling
Clinical narrative: numbness, redness, swelling, warm to touch. arm still numb
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Arthropathy, Immediate post-injection reaction, Injection site pain, Joint range of motion decreased, Magnetic resonance imaging abnormal
Clinical narrative: L shoulder pain immediately after vaccine that persisted and worsened over the subsequent weeks. Reduced ROM and pain persisting  at visits 10/9 and 10/17
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Oedema, Tendon disorder
Clinical narrative: L shoulder pain immediately after vaccine that persisted and worsened over the subsequent weeks. Reduced ROM and pain persisting  at visits 10/9 and 10/17
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: No side effect, just the soreness at injection site
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: FLUZONE HD given on 11/16/23, patient had marked covid on the form.   Pt had already received Fluzone HD on 11/01/23.  no adverse reaction so far, will call tomorrow to follow us.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Fluid intake reduced, Musculoskeletal stiffness, Myalgia, Pruritus
Clinical narrative: Reported Symptoms:  10028813:NAUSEA; 10037087:PRURITUS; 10047700:VOMITING;   Narrative:  Other Relevant HX: Patient called nurse 8/2/23 reporting: Pt is calling to report that since receiving the shingle vaccine on Friday he has had a stiff neck, muscle pain, vomiting and calmly skin. Pt states he is unable to hold down food or fluids  He did has toast today and has kept it in but unable to keep in fluids still. Pt states neck is stiff and locking up. Pt used ginger candy for nausea but it was not effective. Pt was advised to go to ER for eval and TX of s/s and to check for dehydration. Pt v/u. Pt did not say which ER would go to, he states the both are not good and the wait time will be 12 hours. Pt was given the ER notification number.   Patient went to outside facility ER. 8/3/23 the report sent over stated patient seen with: Rash and other Nonspecific Skin Eruption Nothing else follows. Other: NAUSEA AND VOMITING; PRURITUS
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Vomiting
Clinical narrative: Reported Symptoms:  10028813:NAUSEA; 10037087:PRURITUS; 10047700:VOMITING;   Narrative:  Other Relevant HX: Patient called nurse 8/2/23 reporting: Pt is calling to report that since receiving the shingle vaccine on Friday he has had a stiff neck, muscle pain, vomiting and calmly skin. Pt states he is unable to hold down food or fluids  He did has toast today and has kept it in but unable to keep in fluids still. Pt states neck is stiff and locking up. Pt used ginger candy for nausea but it was not effective. Pt was advised to go to ER for eval and TX of s/s and to check for dehydration. Pt v/u. Pt did not say which ER would go to, he states the both are not good and the wait time will be 12 hours. Pt was given the ER notification number.   Patient went to outside facility ER. 8/3/23 the report sent over stated patient seen with: Rash and other Nonspecific Skin Eruption Nothing else follows. Other: NAUSEA AND VOMITING; PRURITUS
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Reported Symptoms:  10046735:URTICARIA;  Narrative:  Other Relevant HX:  Other: URTICARIA
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Pain in extremity
Clinical narrative: Pain in left arm described as "deep, achey... muscle pain + tightness" intermittent.
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Product administration error, Wrong product administered
Clinical narrative: Patient was on our scheduled today for a Covid vaccination. Patient received a flu vaccination today by mistake. Patient already received a flu vaccination on 11/2/2023. I did not realize error until I went to document in patient's chart. Office manager notified. Patient's PCP and Supervising physician notified. I called and spoke with patient's husband. He stated everything was ok and asked that I schedule patient for Covid vaccination.
Age: 82.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, Product administration error, Wrong product administered
Clinical narrative: Patient was on our schedule today for Covid vaccination. Patient received a flu vaccination by mistake today. Patient already received a flu vaccination on 11/2/2023 I did not realize error until I went to document in patient's chart. Office manager notified immediately. Patient's PCP and the Supervising physician both notified. I called and spoke with patient. Patient was ok and asked to be scheduled for covid vaccination.
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Injected limb mobility decreased, Injection site pain
Clinical narrative: Reported Symptoms: 10003239: ARTHRALGIA; 10016256:FATIGUE; 10022086:INJECTION SITE PAIN; 10047862:WEAKNESS;  Narrative: Other Relevant RX:  INTERVENTIONS REQUIRED FOR ADE:  Use of Antypyretic (Specify):APAP 650mg po q6h prn (has not taken any medication - recommended APAP)  IMPACT ON FUNCTION: reports that he received covid vaccine 2 days ago and developed joint pain, weakness, fatigue. "took my 3x longer to make my breakfast this morning and i couldnt participate fully in PT".  reports difficulty raising arm that was vaccinated.    reports that he is still able to eat/drink fluids normally - encouraged increase hydration  recommended to follow up w/PCP if symptoms get worse or do not improve patient reported that he had never had a reaction to the covid vaccine prior  Other: WEAKENSS; FATIGUE;  INJECTION SITE PAIN
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities
Clinical narrative: Reported Symptoms: 10003239: ARTHRALGIA; 10016256:FATIGUE; 10022086:INJECTION SITE PAIN; 10047862:WEAKNESS;  Narrative: Other Relevant RX:  INTERVENTIONS REQUIRED FOR ADE:  Use of Antypyretic (Specify):APAP 650mg po q6h prn (has not taken any medication - recommended APAP)  IMPACT ON FUNCTION: reports that he received covid vaccine 2 days ago and developed joint pain, weakness, fatigue. "took my 3x longer to make my breakfast this morning and i couldnt participate fully in PT".  reports difficulty raising arm that was vaccinated.    reports that he is still able to eat/drink fluids normally - encouraged increase hydration  recommended to follow up w/PCP if symptoms get worse or do not improve patient reported that he had never had a reaction to the covid vaccine prior  Other: WEAKENSS; FATIGUE;  INJECTION SITE PAIN
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Conjunctival oedema, Headache, Hypertension, Myalgia
Clinical narrative: Reported Symptoms:  10008488:CHEST PRESSURE SENSATION OF; 10014218:EDEMA CONJUNCTIVAL; 10016558:FEVER; 10019211:HEADACHE; 10020772:HYPERTENSION; 10028411:MYALGIA; 10042680:SWELLING ARM;   Narrative:  Patient was instructed to see medical advice/ TX. Patient instructed to go to ER immediately for evaluation,  EKG, chest x-ray and appropriate treatment/evaluation. Also, per PCP recommendation, advised dose of Motrin 200mg which he has at home x 1 in setting of inflammation  and see if any improvement.   Other Relevant HX:  Other:  mild chest pressure on the left side, with mild swelling on the left arm pit and pectoral area and left eye mild swelling
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Peripheral swelling, Pyrexia
Clinical narrative: Reported Symptoms:  10008488:CHEST PRESSURE SENSATION OF; 10014218:EDEMA CONJUNCTIVAL; 10016558:FEVER; 10019211:HEADACHE; 10020772:HYPERTENSION; 10028411:MYALGIA; 10042680:SWELLING ARM;   Narrative:  Patient was instructed to see medical advice/ TX. Patient instructed to go to ER immediately for evaluation,  EKG, chest x-ray and appropriate treatment/evaluation. Also, per PCP recommendation, advised dose of Motrin 200mg which he has at home x 1 in setting of inflammation  and see if any improvement.   Other Relevant HX:  Other:  mild chest pressure on the left side, with mild swelling on the left arm pit and pectoral area and left eye mild swelling
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Gait disturbance, Mobility decreased, SARS-CoV-2 test positive, Vertigo
Clinical narrative: I was not able to stay upright and room was pulling to one side, Felt like gravity was pulling her, had to hold wall to walk , she had to walk on the outside by closet and push myself from wall to get my bed. Some say it sounds like Vertigo; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (I was not able to stay upright and room was pulling to one side, Felt like gravity was pulling her, had to hold wall to walk , she had to walk on the outside by closet and push myself from wall to get my bed. Some say it sounds like Vertigo) and COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Biontech COVID-19 vaccine (LOT EL0142, Dose 1) on 05-Jan-2021, Pfizer Biontech COVID-19 vaccine (LOT EL3248, Dose 2) on 26-Jan-2021, Pfizer Biontech COVID-19 vaccine (GH9702, Dose 3) on 17-Sep-2022 and Flu. Past adverse reactions to the above products included No adverse event with Flu, Pfizer Biontech COVID-19 vaccine, Pfizer Biontech COVID-19 vaccine and Pfizer Biontech COVID-19 vaccine. Concurrent medical conditions included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX), DICLOFENAC POTASSIUM (CAMBIA) and UBROGEPANT (UBRELVY) for Migraine, PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 04-Nov-2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (COVID-19). In 2023, the patient experienced VERTIGO (I was not able to stay upright and room was pulling to one side, Felt like gravity was pulling her, had to hold wall to walk , she had to walk on the outside by closet and push myself from wall to get my bed. Some say it sounds like Vertigo). At the time of the report, VERTIGO (I was not able to stay upright and room was pulling to one side, Felt like gravity was pulling her, had to hold wall to walk , she had to walk on the outside by closet and push myself from wall to get my bed. Some say it sounds like Vertigo) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: Positive.         Treatment medication was not reported.  The patient felt like gravity was pulling and had to hold wall to walk. It sound like vertigo. The patient had 3-4 episodes like this in jul-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-748829 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748829:Master case for SPIKEVAX 2023-2024
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023USL00904.  A 67-year-old female patient received bnt162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots". Clinical course: On 27Oct2023, it was reported that in Apr2021, a patient received the Pfizer COVID-19 shot. Subsequently, on an unreported date, the patient developed blood clots.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Arthralgia, Erythema, Injected limb mobility decreased, Injection site pain, Mass
Clinical narrative: Patient stated she had severe arm pain starting the following day of rsv vaccination. We followed up with  her the next two days and we offered to call her doctor but she declined.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Patient stated she had severe arm pain starting the following day of rsv vaccination. We followed up with  her the next two days and we offered to call her doctor but she declined.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Erythema, Injection site pain, Mass, Mobility decreased, Pain
Clinical narrative: Patient stated she had severe arm pain starting the following day of rsv vaccination. We followed up with  her the next two days and we offered to call her doctor but she declined.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Pain in extremity
Clinical narrative: Patient stated she had severe arm pain starting the following day of rsv vaccination. We followed up with  her the next two days and we offered to call her doctor but she declined.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chills, Disorientation, Dizziness, Headache
Clinical narrative: w/in 5 min I felt dizzy w/ spotty vision and felt like I was going to pass out, BP was over 180/90s and I have low BP usually. tried to leave after most s/s subsided but another episode started and it was worse. couldn't walk got SEVERE HA & vision left again and started dry heaving.  EMTs called by Rx as I was having trouble lifting my head and arms and my lips were numb w/ garbled speech. Had palpitations at start of both events. EMTs stated my BP was even higher, almost 200/100 and thot I was goig to stroke. This is called HYPERTENSIVE CRISIS and I could have STROKED!!I have insurance that doesn't cover anything so refused ER. Took 90 mins before I could see well enough to drive,BP 150/106 now had to start BP pil
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Vision blurred
Clinical narrative: w/in 5 min I felt dizzy w/ spotty vision and felt like I was going to pass out, BP was over 180/90s and I have low BP usually. tried to leave after most s/s subsided but another episode started and it was worse. couldn't walk got SEVERE HA & vision left again and started dry heaving.  EMTs called by Rx as I was having trouble lifting my head and arms and my lips were numb w/ garbled speech. Had palpitations at start of both events. EMTs stated my BP was even higher, almost 200/100 and thot I was goig to stroke. This is called HYPERTENSIVE CRISIS and I could have STROKED!!I have insurance that doesn't cover anything so refused ER. Took 90 mins before I could see well enough to drive,BP 150/106 now had to start BP pil
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blindness, Dizziness, Dysarthria, Gait inability
Clinical narrative: w/in 5 min I felt dizzy w/ spotty vision and felt like I was going to pass out, BP was over 180/90s and I have low BP usually. tried to leave after most s/s subsided but another episode started and it was worse. couldn't walk got SEVERE HA & vision left again and started dry heaving.  EMTs called by Rx as I was having trouble lifting my head and arms and my lips were numb w/ garbled speech. Had palpitations at start of both events. EMTs stated my BP was even higher, almost 200/100 and thot I was goig to stroke. This is called HYPERTENSIVE CRISIS and I could have STROKED!!I have insurance that doesn't cover anything so refused ER. Took 90 mins before I could see well enough to drive,BP 150/106 now had to start BP pil
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypertension, Hypertensive crisis, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: w/in 5 min I felt dizzy w/ spotty vision and felt like I was going to pass out, BP was over 180/90s and I have low BP usually. tried to leave after most s/s subsided but another episode started and it was worse. couldn't walk got SEVERE HA & vision left again and started dry heaving.  EMTs called by Rx as I was having trouble lifting my head and arms and my lips were numb w/ garbled speech. Had palpitations at start of both events. EMTs stated my BP was even higher, almost 200/100 and thot I was goig to stroke. This is called HYPERTENSIVE CRISIS and I could have STROKED!!I have insurance that doesn't cover anything so refused ER. Took 90 mins before I could see well enough to drive,BP 150/106 now had to start BP pil
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Palpitations, Pyrexia, Retching
Clinical narrative: w/in 5 min I felt dizzy w/ spotty vision and felt like I was going to pass out, BP was over 180/90s and I have low BP usually. tried to leave after most s/s subsided but another episode started and it was worse. couldn't walk got SEVERE HA & vision left again and started dry heaving.  EMTs called by Rx as I was having trouble lifting my head and arms and my lips were numb w/ garbled speech. Had palpitations at start of both events. EMTs stated my BP was even higher, almost 200/100 and thot I was goig to stroke. This is called HYPERTENSIVE CRISIS and I could have STROKED!!I have insurance that doesn't cover anything so refused ER. Took 90 mins before I could see well enough to drive,BP 150/106 now had to start BP pil
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: w/in 5 min I felt dizzy w/ spotty vision and felt like I was going to pass out, BP was over 180/90s and I have low BP usually. tried to leave after most s/s subsided but another episode started and it was worse. couldn't walk got SEVERE HA & vision left again and started dry heaving.  EMTs called by Rx as I was having trouble lifting my head and arms and my lips were numb w/ garbled speech. Had palpitations at start of both events. EMTs stated my BP was even higher, almost 200/100 and thot I was goig to stroke. This is called HYPERTENSIVE CRISIS and I could have STROKED!!I have insurance that doesn't cover anything so refused ER. Took 90 mins before I could see well enough to drive,BP 150/106 now had to start BP pil
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Around 10 days after RSV vaccination, patient presented to hospital ED with chest pain, bilateral feet numbness, and difficulty ambulating.  Patient was seen by neurology physician who was concerned for Guillain-Barre syndrome; MRI was done as well as IVIG given x 5 days, then high-dose Solu-medrol.  Patient was diagnosed with acute disseminated encephalomyelitis, precipitated by the RSV vaccine.  Soon after discontinuation of the Solu-medrol, the patients neurologic status declined significantly, requiring intubation.  Patient was transferred to Hospital neuro ICU. Patient deceased on 11/15/2023.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Acute disseminated encephalomyelitis, CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Chest pain
Clinical narrative: Around 10 days after RSV vaccination, patient presented to hospital ED with chest pain, bilateral feet numbness, and difficulty ambulating.  Patient was seen by neurology physician who was concerned for Guillain-Barre syndrome; MRI was done as well as IVIG given x 5 days, then high-dose Solu-medrol.  Patient was diagnosed with acute disseminated encephalomyelitis, precipitated by the RSV vaccine.  Soon after discontinuation of the Solu-medrol, the patients neurologic status declined significantly, requiring intubation.  Patient was transferred to Hospital neuro ICU. Patient deceased on 11/15/2023.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Death, Endotracheal intubation, Gait disturbance, Heparin-induced thrombocytopenia test, Hypoaesthesia
Clinical narrative: Around 10 days after RSV vaccination, patient presented to hospital ED with chest pain, bilateral feet numbness, and difficulty ambulating.  Patient was seen by neurology physician who was concerned for Guillain-Barre syndrome; MRI was done as well as IVIG given x 5 days, then high-dose Solu-medrol.  Patient was diagnosed with acute disseminated encephalomyelitis, precipitated by the RSV vaccine.  Soon after discontinuation of the Solu-medrol, the patients neurologic status declined significantly, requiring intubation.  Patient was transferred to Hospital neuro ICU. Patient deceased on 11/15/2023.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Immunoglobulin therapy, Intensive care, Laboratory test normal, Leukoencephalopathy, Macrophage count
Clinical narrative: Around 10 days after RSV vaccination, patient presented to hospital ED with chest pain, bilateral feet numbness, and difficulty ambulating.  Patient was seen by neurology physician who was concerned for Guillain-Barre syndrome; MRI was done as well as IVIG given x 5 days, then high-dose Solu-medrol.  Patient was diagnosed with acute disseminated encephalomyelitis, precipitated by the RSV vaccine.  Soon after discontinuation of the Solu-medrol, the patients neurologic status declined significantly, requiring intubation.  Patient was transferred to Hospital neuro ICU. Patient deceased on 11/15/2023.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Meningioma, Neurological decompensation, Platelet count decreased
Clinical narrative: Around 10 days after RSV vaccination, patient presented to hospital ED with chest pain, bilateral feet numbness, and difficulty ambulating.  Patient was seen by neurology physician who was concerned for Guillain-Barre syndrome; MRI was done as well as IVIG given x 5 days, then high-dose Solu-medrol.  Patient was diagnosed with acute disseminated encephalomyelitis, precipitated by the RSV vaccine.  Soon after discontinuation of the Solu-medrol, the patients neurologic status declined significantly, requiring intubation.  Patient was transferred to Hospital neuro ICU. Patient deceased on 11/15/2023.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Thrombocytopenia
Clinical narrative: Around 10 days after RSV vaccination, patient presented to hospital ED with chest pain, bilateral feet numbness, and difficulty ambulating.  Patient was seen by neurology physician who was concerned for Guillain-Barre syndrome; MRI was done as well as IVIG given x 5 days, then high-dose Solu-medrol.  Patient was diagnosed with acute disseminated encephalomyelitis, precipitated by the RSV vaccine.  Soon after discontinuation of the Solu-medrol, the patients neurologic status declined significantly, requiring intubation.  Patient was transferred to Hospital neuro ICU. Patient deceased on 11/15/2023.
Age: 79.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Around 10 days after RSV vaccination, patient presented to hospital ED with chest pain, bilateral feet numbness, and difficulty ambulating.  Patient was seen by neurology physician who was concerned for Guillain-Barre syndrome; MRI was done as well as IVIG given x 5 days, then high-dose Solu-medrol.  Patient was diagnosed with acute disseminated encephalomyelitis, precipitated by the RSV vaccine.  Soon after discontinuation of the Solu-medrol, the patients neurologic status declined significantly, requiring intubation.  Patient was transferred to Hospital neuro ICU. Patient deceased on 11/15/2023.
Age: 84.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia, Dizziness, Malaise
Clinical narrative: excruciating joint pain in hips, knees, toes and shoulders lasting for 12 to 16 hours
Age: 84.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Arthralgia
Clinical narrative: excruciating joint pain in hips, knees, toes and shoulders lasting for 12 to 16 hours
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; VARIVAX was administered during a T/E; This spontaneous report was received from a nurse and refers to a 51-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided.  On 16-OCT-2023, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose subcutaneously in left arm, lot # X010525 expiration date 11-APR-2025 (exact dose was not provided), for prophylaxis. The vaccine was previously incorrectly stored at a temperature of 12.5 Fahrenheit degrees for 25 minutes. Varicella virus vaccine live (oka/merck)(VARIVAX) was administered prior to determining vaccine was viable. The vaccine was determined to be viable. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The caller stated doses of improperly stored VARIVAX were administered to patients; No additional adverse events were reported; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W039294 with expiration date on 11-DEC-2024, administered for prophylaxis (dose, route of administration, and anatomical location were not provided) (product storage error). The excursion ocurred at a temperature of 17.4°F for 2 hours. No previous temperature excursions were reported, and no additional adverse events were reported.