chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Skin warm, Vomiting
Clinical narrative: At 11:50 after administering 3rd vaccine MCV4 about 40 seconds later, child had jerking of body effect lasting about 3 to 4 seconds. She did not lose conscious says she was nervous and scared. Skin was pallor, vital signs taken 110/70 blood pressure, 72 pulse, 18 respirations. Child denied any dizziness, skin was warm to touch. Child felt nauseated and expelled clear vomit. Mom stated child had not eaten breakfast. Applied cool pack to back of neck area, child felt better after 20 minutes. Instructed parent if child did not feel well to seek medical provider or emergency room. Parent verbalized comprehension. Child was oriented and talking before leaving.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory symptom, SARS-CoV-2 test
Clinical narrative: Upper respiratory symptoms
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: PATIENT NEEDED INFLUENZA NOT TDAP
Age: 45.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient came in to pharmacy and reported to Rph and Technician that his upper right  arm has been hurting since he had the Boostrix vaccine in May, 6 months ago.  He stated he hasn't reported to us prior  or seek medical help for it.  He mentioned that he can feel a bump or swelling at the site of Boostrix injection.  Attempting to confirm it,  with a glove on, I try to feel what he was describing .  I did not notice any lump or swelling, nor did I notice any difference with the other arm.  The patient was a native speaking, not fluent, thus Tech. was there to translate.  We advised him to go see his Doctor.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Duplicate vaccine with no side effects
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased
Clinical narrative: Headache, muscle aches and nausea within 12 hours of receiving vaccine. Dark yellow urine, light headedness. Sent home from work four days after vaccine due to increased nausea, paleness, and total body muscle soreness. Unable to pass bowel for next weak, abdominal pain and distension. Inability to move. Started seeing spots in vision 10 days after vaccine. Admitted to hospital 10/30/2023 with dehydration, difficulty breathing.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood bilirubin increased, Blood smear test, Chromaturia, Computerised tomogram abdomen abnormal, Constipation
Clinical narrative: Headache, muscle aches and nausea within 12 hours of receiving vaccine. Dark yellow urine, light headedness. Sent home from work four days after vaccine due to increased nausea, paleness, and total body muscle soreness. Unable to pass bowel for next weak, abdominal pain and distension. Inability to move. Started seeing spots in vision 10 days after vaccine. Admitted to hospital 10/30/2023 with dehydration, difficulty breathing.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Culture urine, Dehydration, Differential white blood cell count, Dizziness, Dyspnoea
Clinical narrative: Headache, muscle aches and nausea within 12 hours of receiving vaccine. Dark yellow urine, light headedness. Sent home from work four days after vaccine due to increased nausea, paleness, and total body muscle soreness. Unable to pass bowel for next weak, abdominal pain and distension. Inability to move. Started seeing spots in vision 10 days after vaccine. Admitted to hospital 10/30/2023 with dehydration, difficulty breathing.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Gallbladder enlargement, Haematocrit decreased, Haemoglobin decreased, Headache
Clinical narrative: Headache, muscle aches and nausea within 12 hours of receiving vaccine. Dark yellow urine, light headedness. Sent home from work four days after vaccine due to increased nausea, paleness, and total body muscle soreness. Unable to pass bowel for next weak, abdominal pain and distension. Inability to move. Started seeing spots in vision 10 days after vaccine. Admitted to hospital 10/30/2023 with dehydration, difficulty breathing.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Human chorionic gonadotropin, Hypertransaminasaemia, Impaired work ability, Lipase, Mobility decreased
Clinical narrative: Headache, muscle aches and nausea within 12 hours of receiving vaccine. Dark yellow urine, light headedness. Sent home from work four days after vaccine due to increased nausea, paleness, and total body muscle soreness. Unable to pass bowel for next weak, abdominal pain and distension. Inability to move. Started seeing spots in vision 10 days after vaccine. Admitted to hospital 10/30/2023 with dehydration, difficulty breathing.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Mononucleosis heterophile test positive, Myalgia, Nausea, Pallor, Reticulocyte count
Clinical narrative: Headache, muscle aches and nausea within 12 hours of receiving vaccine. Dark yellow urine, light headedness. Sent home from work four days after vaccine due to increased nausea, paleness, and total body muscle soreness. Unable to pass bowel for next weak, abdominal pain and distension. Inability to move. Started seeing spots in vision 10 days after vaccine. Admitted to hospital 10/30/2023 with dehydration, difficulty breathing.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Scan with contrast abnormal, Splenomegaly, Visual impairment
Clinical narrative: Headache, muscle aches and nausea within 12 hours of receiving vaccine. Dark yellow urine, light headedness. Sent home from work four days after vaccine due to increased nausea, paleness, and total body muscle soreness. Unable to pass bowel for next weak, abdominal pain and distension. Inability to move. Started seeing spots in vision 10 days after vaccine. Admitted to hospital 10/30/2023 with dehydration, difficulty breathing.
Age: 81.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Headache, Subdural haematoma
Clinical narrative: About 8-10 days after administration of vaccines, patient started experiencing persistent Headaches and bouts of lightheadedness.  He toke OTC medication for headache, which improved the pain, but the headache was persistent.  On 11/1 he was taken the ED and diagnosed with a subdural hematoma.  Patient's friend reported to the pharmacy and asked to report.
Age: 67.0
Sex: M
Vaccine: PNC20
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient experienced rash and swelling on 2/3 of left arm 2 days post vaccination. including itching.  Recommended Benadryl and topical hydrocortisone.  If progression continues seek medical attention
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Blood test, Chest pain, Electrocardiogram
Clinical narrative: Chest pain, pounding heartbeat, anxiety, back pain for 2 days, diagnosed with pericarditis in the ER. Prescribed colchicine and aspirin and was referred to a cardiologist.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pericarditis, X-ray
Clinical narrative: Chest pain, pounding heartbeat, anxiety, back pain for 2 days, diagnosed with pericarditis in the ER. Prescribed colchicine and aspirin and was referred to a cardiologist.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Malaise, Seizure, Syncope
Clinical narrative: Patient was very nervous about receiving the vaccination. Following the vaccination, patient stated the she "did not feel well" and that she "felt like she was going to pass out". Immediately, mother stated that when she passes out she has seizures. Within 45 seconds, patient fainted and started seizing on and off for 2-3 minutes in the chair and mother and I prevented her from falling. Patient fully recovered within 15 minutes after drinking water and resting.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller reported PROQUAD and VARIVAX were administered after a temperature excursion; This spontaneous report was received from a consumer (reporter qualifications not provided) concerning an unknown number of patients of unspecified age and gender. The patients' medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On unreported date (s), doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 6.008 degrees Fahrenheit (F) during a timeframe of 30 minutes with previous temperature excursion.   On unspecified date (s), the patients were vaccinated with improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) lot #X021753, expiration date 23-FEB-2025 (dosage regimen, exact dose, anatomical location and route of administration were not provided); and/or varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # W031812, expiration date 05-OCT-2024 (dosage regimen, exact dose, anatomical location and route of administration were not provided) (product storage error). Both vaccines were administered as prophylaxis.  No other adverse events (AE) were reported (no adverse event). This report was considered to be non-valid due to lack of patients' identifiers.  Follow up information was received from from other healthcare professional regarding a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 24-SEP-2024, the patient was vaccinated at public health clinic/hospital with public funds with an improperly stored doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) intramuscular and varicella virus vaccine live (oka/merck) (VARIVAX). The temperature excursion was for less than 30 minutes.  It was mentioned that the point in the process the medication error occurred was storage in clinical practice; the operator of vaccines was healthcare professional and was trained. Also it was reported that although temperature excursion the vaccines were ok to be used.  This is one of several reports received from the same reporter.  This case was initially received without patient identifiers and handled as non-valid. Now that patient identifiers are being provided by the reporter, the case is handled as a valid case and distributed accordingly.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chest discomfort, Chest pain, Electrocardiogram, Pericarditis
Clinical narrative: Patient received the Covid shot along with the High Dose Flu shot on 10/4/24. He started experiencing symptoms on 10/8/24. The patient reports that his symptoms at the time were tightness in chest that got progressively worse. He thought he was experiencing some muscle pains. So he took Ibuprofen 800 mg and continued taking that until he went to an urgent care clinic on 10/26/24. When the symptoms did not resolve, he went to his primary care physician on 10/29/24. The visits did not resolve his issues, so he went to the ER on 11/4/24. He stayed at the hospital for 6 days. His diagnosis at the hospital was chest pain and pericarditis. The medications that he was given at the hospital are Prednisone, Heparin, Bactrim, an acid reflux medication and there are other medications.
Age: 73.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Influenza like illness
Clinical narrative: PER PATIENT, SHE HAD SYNCOPE, SOB, FATIGUE, CHILLS, DIZZINESS, ETC (FLU-LIKE SYMPTOMS HOWEVER SHE FELT THEY WERE SEVERE, COULDN'T GET OUT BED FOR 2 DAYS)
Age: 73.0
Sex: F
Vaccine: COVID19, PNC21
Symptoms: Mobility decreased, Syncope
Clinical narrative: PER PATIENT, SHE HAD SYNCOPE, SOB, FATIGUE, CHILLS, DIZZINESS, ETC (FLU-LIKE SYMPTOMS HOWEVER SHE FELT THEY WERE SEVERE, COULDN'T GET OUT BED FOR 2 DAYS)
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Asthma, Condition aggravated, Cough, Rhinorrhoea
Clinical narrative: Coughing, asthma effects, runny nose
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient stated that they experience leg soreness that radiated down their legs.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Pt developed rash and swelling at administration site. Rash resolved after one week. Pt did not take any medication for treatment.
Age: 74.0
Sex: M
Vaccine: COVID19, RSV, UNK
Symptoms: Blood thyroid stimulating hormone, Differential white blood cell count, Echocardiogram, Electrocardiogram, Full blood count
Clinical narrative: None stated.
Age: 15.0
Sex: F
Vaccine: FLU3, HPV9, SMALL, VARCEL
Symptoms: Deafness, Dizziness
Clinical narrative: Student complained of feeling dizzy and cannot hear after receiving the vaccines.  Student is awake, alert, and oriented. Assisted student to lay down with feet elevated. Vital signs taken: 3:05pm: BP: 95/48, HR 52 bpm, RR 16. 3:10pm: BP 110/60 HR 47bp,. RR 20. Denies dizziness and loss of hearing. No difficulty breathing noted. Assisted patient to sit up. BP: 109/66, HR 47bpm, RR 16. Denies dizziness at sitting position.  3:15pm: BP 106/60, HR 47 bpm, RR 16. Feels well. 3:20pm: BP 106/63, HR 55 bpm, RR 16.  3:25pm: Student stood up with no dizziness. BP: 102/62, HR 51, RR 16. Student went home with parent with no incidence.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Softball size red, warm, firm lump at injection site, worsening on day 2
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: THE NEEDLE RETRACTED INTO THE SYRINGE WHEN THE PLUNGER WAS PUSHED IN AND THE DOSE RAN DOWN THE PATIENT'S ARM. THE PATIENT WILL REPEAT THE DOSE IN ONE WEEK.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling abnormal, Sepsis, Tremor
Clinical narrative: Shaking and feeling funny for over 24 hours after receiving Prevnar 20. Patient has been admitted to the hospital for sepsis which she claims began after receiving Prevnar 20 yesterday afternoon.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Skin itching and mild rash on left side of back just above waist. More severe rash on calves, back of knees and lower thighs. Rash gradually subsided over the next few days, disappeared a week later. No treatment.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 29.0
Sex: F
Vaccine: COVID19, HEPA, HPV9, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pt states she had low grade fever, pain and swelling at injection site, upset stomach, diarrhea,  and body aches starting on 11/06 and continuing until 11/13.
Age: 29.0
Sex: F
Vaccine: COVID19, HEPA, HPV9, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt states she had low grade fever, pain and swelling at injection site, upset stomach, diarrhea,  and body aches starting on 11/06 and continuing until 11/13.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Discomfort
Clinical narrative: Around 10 hours after receiving the vaccines I began feeling fatigued, generally uncomfortable, and cold. Approximately midnight, 13 hours after injections, I had severe chills and could not stop shaking, my whole body hurts, and I had a strong headache. Chills and shaking lasted an unknown length of time, but resolved by 2:30am on 11/12/24.  At that point, I felt a significant amount of muscle and joint pain, and still had a headache, so I took two extra strength Tylenol. I woke at 4:30am and it felt like I didn't use any pain reliever. I would go on to take 1g of Tylenol every 4 hours, for a total of four doses. The whole day it felt like my body temperature would not regulate. Mild nausea and some decreased appetite. I was still very fatigued by the evening of the 12th, and went to bed early. I had mild chills overnight. As of the 13th, I still feel tired, joint and muscle pain is mild, and the headache persists. My stomach started feeling gassy, and bowel sounds were very loud by 4pm. Around 6pm I had severe, watery diarrhea, and the stool that I could see was darker than normal.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fatigue, Feeling cold, Flatulence, Gastrointestinal sounds abnormal, Headache
Clinical narrative: Around 10 hours after receiving the vaccines I began feeling fatigued, generally uncomfortable, and cold. Approximately midnight, 13 hours after injections, I had severe chills and could not stop shaking, my whole body hurts, and I had a strong headache. Chills and shaking lasted an unknown length of time, but resolved by 2:30am on 11/12/24.  At that point, I felt a significant amount of muscle and joint pain, and still had a headache, so I took two extra strength Tylenol. I woke at 4:30am and it felt like I didn't use any pain reliever. I would go on to take 1g of Tylenol every 4 hours, for a total of four doses. The whole day it felt like my body temperature would not regulate. Mild nausea and some decreased appetite. I was still very fatigued by the evening of the 12th, and went to bed early. I had mild chills overnight. As of the 13th, I still feel tired, joint and muscle pain is mild, and the headache persists. My stomach started feeling gassy, and bowel sounds were very loud by 4pm. Around 6pm I had severe, watery diarrhea, and the stool that I could see was darker than normal.
Age: 53.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Myalgia, Nausea, Pain, Tremor
Clinical narrative: Around 10 hours after receiving the vaccines I began feeling fatigued, generally uncomfortable, and cold. Approximately midnight, 13 hours after injections, I had severe chills and could not stop shaking, my whole body hurts, and I had a strong headache. Chills and shaking lasted an unknown length of time, but resolved by 2:30am on 11/12/24.  At that point, I felt a significant amount of muscle and joint pain, and still had a headache, so I took two extra strength Tylenol. I woke at 4:30am and it felt like I didn't use any pain reliever. I would go on to take 1g of Tylenol every 4 hours, for a total of four doses. The whole day it felt like my body temperature would not regulate. Mild nausea and some decreased appetite. I was still very fatigued by the evening of the 12th, and went to bed early. I had mild chills overnight. As of the 13th, I still feel tired, joint and muscle pain is mild, and the headache persists. My stomach started feeling gassy, and bowel sounds were very loud by 4pm. Around 6pm I had severe, watery diarrhea, and the stool that I could see was darker than normal.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Eye movement disorder, Fall, Head injury, Musculoskeletal stiffness, Mydriasis
Clinical narrative: Patient received the flu shot. She then stayed seating while the immunizer gave a vaccine to someone else. Then 10 minutes after receiving the vaccine, she stood up and went to the register. At the register the patient fell suddenly, as she was falling she hit her head on a grocery customer's cart. She continued to fall and hit her head on the ground as well. Once on the ground she her body shook a little and her right arm tensed up (potential seizure activity). Her mom reported that when she was first on the ground her eyes looked rolling back slightly. Then she became more alert and knew what day of the week it was. After that patient was able to sit up. One of her pupils was dilated. We gave her cold water and put an ice pack on where she bumped her head. Patient sat for 10 minutes while waiting for emergency services to arrive. During that time her pupils went back to normal size. Emergency medical services determined her alertness and verified that she knew where she was and what day it was. Her mom then walked her out with EMS and was going to drive her to the emergency room for further evaluation.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Patient received the flu shot. She then stayed seating while the immunizer gave a vaccine to someone else. Then 10 minutes after receiving the vaccine, she stood up and went to the register. At the register the patient fell suddenly, as she was falling she hit her head on a grocery customer's cart. She continued to fall and hit her head on the ground as well. Once on the ground she her body shook a little and her right arm tensed up (potential seizure activity). Her mom reported that when she was first on the ground her eyes looked rolling back slightly. Then she became more alert and knew what day of the week it was. After that patient was able to sit up. One of her pupils was dilated. We gave her cold water and put an ice pack on where she bumped her head. Patient sat for 10 minutes while waiting for emergency services to arrive. During that time her pupils went back to normal size. Emergency medical services determined her alertness and verified that she knew where she was and what day it was. Her mom then walked her out with EMS and was going to drive her to the emergency room for further evaluation.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received a dose of Abrysvo 12/1/23.  At present a follow-up dose is not part of the guidelines for this vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Hypopnoea, Pallor, Presyncope, Pulse abnormal
Clinical narrative: Upon administration of influenza vaccine during mass vaccination patient was instructed to wait 15 minutes for any type of reaction, the staff were notified by other patients waiting that there was a medical emergency. Staff immediately respond to a patient with a pale, clammy and near syncope. Staff immediately check airway, breathing, and circulation. Patient has a weak pulse, shallow breathing and with slow coherence. Staff placed the patient into a supine position on the floor and lifted the patient legs, which the patient tolerated well. The event had occurred approximately 8-10 minutes and was transferred to different care within the clinic to ensure all labs and imaging within normal limits before releasing the patient.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Incorrect Covid formula administered to patient. Patient received Covid-19 Vaccine, mRNA Comirnaty 2023-2024 formula. Covid vaccine was stored improperly in the refrigerator with an expiration date on vial of 01/2025. No reported concerns by patient.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt came in with redness around injection sites of both arms. It was tender and warm to touch. Recommended icing and ibuprofen; benadryl if needed. Will followup with pt in a few days.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Peripheral swelling, Pruritus
Clinical narrative: Eyes and finger swelled up and got very itchy. After one Benadryl swelling and itching stopped.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Cramps everywhere
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction, just gave MMRV instead of MMR
Age: 22.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Provider ordered a Varivax and a Proquad was accidently given.
Age: 78.0
Sex: M
Vaccine: SMALL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Pfizer Comirnaty vaccine on 10/22/2024.  A few weeks later, the patient's wife came in to get her Covid shot and we saw that her husband actually received the Moderna Spikevax on 10/15/2024 prior to the Pfizer one.  Wife had said the husband was fine with no bad side effects.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Muscle spasms, Nausea, Syncope, Vomiting
Clinical narrative: Patient fainted about two hours after receiving her 2nd Shingrix vaccine. She had to go to the hospital and after several tests it was just a reaction to the vaccine. She had nausea and vomiting and lingering bone and muscle cramping 2 weeks after the episode.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Cold sweat, Dizziness
Clinical narrative: I worked until 2am without any issues (10 hours post injection) but then woke up at 9am (17 hours post injection) with most of my muscles and joints aching Consistent with past Moderna COVID Vaccinations).  My monitor showed my body temp overnight up 0.5 degrees and my HRV lower at 22. My respiratory rate at 15.2/min and  resting heart rate at 57 bpm were within the normal range. (Shortly after noon today (20 hours after injection) I was playing tennis and started to feel clammy and a bit dizzy then nauseous.  By 2:45 pm, I was home in bed with chills and a headache and just slept 4 hours. I still feel very tired , a bit warm, and have a light headache.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate variability decreased, Myalgia, Nausea
Clinical narrative: I worked until 2am without any issues (10 hours post injection) but then woke up at 9am (17 hours post injection) with most of my muscles and joints aching Consistent with past Moderna COVID Vaccinations).  My monitor showed my body temp overnight up 0.5 degrees and my HRV lower at 22. My respiratory rate at 15.2/min and  resting heart rate at 57 bpm were within the normal range. (Shortly after noon today (20 hours after injection) I was playing tennis and started to feel clammy and a bit dizzy then nauseous.  By 2:45 pm, I was home in bed with chills and a headache and just slept 4 hours. I still feel very tired , a bit warm, and have a light headache.
Age: 29.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Pain in extremity, Syncope
Clinical narrative: Patient fainted for a few minutes or less than 1 minute?  post covid vaccination on 11/9/24.  After he regained consciousness, he decided it was not necessary  for pharmacy team to call EMS or for him to go to ED for additional tests/treatments.  He reported that similar incidences happened multiple times in the past after blood draws and after he accidentally cut himself at home.  He sat and rested in the pharmacy waiting area for 40 minutes before he left the store. He drank water and ate snacks while he was sitting and resting.  Pharmacist reinforced with patient that he has to inform healthcare providers that he has vasovagal syncope and reaction (fainting) to (covid) vaccine in the future.  On 11/13/24, pharmacist called patient to follow-up.  Patient reported he has been feeling completely normal ( no discomfort or abnormality), except a little soreness on his right arm. Pharmacist also recommended patient to consider getting vaccines in outpatient clinic of hospitals where crash carts are available.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Contusion
Clinical narrative: Bruising still after having Flu vaccine and Spikevax vaccine on 11/5
Age: 56.0
Sex: F
Vaccine: FLU3, HEP, PNC20
Symptoms: Injection site reaction, Pain in extremity, Rash macular
Clinical narrative: Pt came in and showed me her right deltoid. There was a blotchy area on her right deltoid. She stated it didn't itch and she only noticed it in the shower. Her arm had been sore, but nothing more than expected from any shot. It was 7 days since she received it. I told her to watch the area and if it got bigger or got itchy to contact a provider. I left a message for the patient so I could follow up and see how she is doing. I will also pass on information that if it becomes warm to the touch it could be an infection.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Dyspnoea, Fatigue
Clinical narrative: I started having shortness of breath and fatigue 3 days after I received the covid 19 vaccinne, and had a stroke right in my office 4 weeks after I took the vaccsine, on July 26th 2021
Age: 27.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Oral pruritus, Pruritus
Clinical narrative: I was very itchy all over my entire body, I was so itchy and couldn?t stop itching. The roof of my mouth was itchy too. I was given steroids to help with the itching. I also got an epipen because I was told that my reaction was a pre-anaphylactic reaction.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate decreased, Hypotension, Palpitations
Clinical narrative: Low heart and blood pressure and heart palpitations
Age: 10.0
Sex: F
Vaccine: COVID19, FLU3, HEP, HEPA, IPV, MMRV, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Event: Pt had vasovagal syncopal episode while seated immediately after vaccination. No fall occurred. Treatment: Pt's legs were raised and head was lowered. Vital signs taken and were normal. BP 118/78, HR 80, RR 12, O2 100%. Pt was offered and accepted juice and a cold pack. Pt monitored/observed for approx 30 minutes. Pt was able to converse and walk normally upon leaving facility.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Antiphospholipid antibodies, Autoimmune thyroiditis, Blood thyroid stimulating hormone, Fatigue
Clinical narrative: Began having severe pots symptoms, headaches, my histamine levels spiked, developed histamine intolerance, was having wild fatigue and other issues and was diagnosed with Hashimoto. Was treated for that and still felt terrible then got diagnosed with lupus. I felt off after the first t vaccine but it was the second one that really sent my immune system spiraling.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Histamine intolerance, Histamine level increased, Postural orthostatic tachycardia syndrome, Systemic lupus erythematosus
Clinical narrative: Began having severe pots symptoms, headaches, my histamine levels spiked, developed histamine intolerance, was having wild fatigue and other issues and was diagnosed with Hashimoto. Was treated for that and still felt terrible then got diagnosed with lupus. I felt off after the first t vaccine but it was the second one that really sent my immune system spiraling.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Near death experience
Clinical narrative: I had the Delta variant in Jul; I had the Delta variant in Jul; I've cheated death three times now; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (disability, life threatening), COVID-19 (disability, life threatening), outcome "unknown" and all described as "I had the Delta variant in Jul"; NEAR DEATH EXPERIENCE (disability, life threatening), outcome "unknown", described as "I've cheated death three times now". Clinical Course: Description of Event Outcome: Patient was having severe physical disabilities ever since 2021. Patient had two Pfizer vaccines, which didn't go well, had the Delta variant in Jul. Patient had cheated death three times now, so disabled patient can't even work. This was extremely difficult on patient and patient beg to help, (name withheld).
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Asthenia, Computerised tomogram normal, Fall, Gait disturbance, Laboratory test
Clinical narrative: Patient fell, unable to walk or care for self
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Urine analysis, Walking aid user, X-ray limb normal
Clinical narrative: Patient fell, unable to walk or care for self
Age: 83.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Fall, Gait inability, Loss of personal independence in daily activities
Clinical narrative: Patient fell, unable to walk or care for self
Age: 47.0
Sex: F
Vaccine: UNK, FLU3, FLU3
Symptoms: Corneal opacity, Eye discharge, Ocular hyperaemia
Clinical narrative: After receiving the seasonal influenza vaccine from a work place event, patient started having itching and swelling in her eyes. States the swelling became so bad that she needed to seek medical attention. Patient reports that this has happened over the last two previous years since getting the flu vaccine from workplace. Investigating the flu vaccines that she received over the last three years, the vaccine received were all from ID Biomedical. The list of adverse side effects are indeed: Grade 3 reddened eyes and Grade 3 facial swelling which she has experienced over the last 3 years. Each year after exposure, the symptoms worsened.
Age: 47.0
Sex: F
Vaccine: UNK, FLU3, FLU3
Symptoms: Eye pain, Eye pruritus, Headache, Ocular hyperaemia, Swelling of eyelid
Clinical narrative: After receiving the seasonal influenza vaccine from a work place event, patient started having itching and swelling in her eyes. States the swelling became so bad that she needed to seek medical attention. Patient reports that this has happened over the last two previous years since getting the flu vaccine from workplace. Investigating the flu vaccines that she received over the last three years, the vaccine received were all from ID Biomedical. The list of adverse side effects are indeed: Grade 3 reddened eyes and Grade 3 facial swelling which she has experienced over the last 3 years. Each year after exposure, the symptoms worsened.
Age: 47.0
Sex: F
Vaccine: UNK, FLU3, FLU3
Symptoms: Vision blurred, Visual acuity tests
Clinical narrative: After receiving the seasonal influenza vaccine from a work place event, patient started having itching and swelling in her eyes. States the swelling became so bad that she needed to seek medical attention. Patient reports that this has happened over the last two previous years since getting the flu vaccine from workplace. Investigating the flu vaccines that she received over the last three years, the vaccine received were all from ID Biomedical. The list of adverse side effects are indeed: Grade 3 reddened eyes and Grade 3 facial swelling which she has experienced over the last 3 years. Each year after exposure, the symptoms worsened.
Age: 47.0
Sex: F
Vaccine: UNK, FLU3, FLU3
Symptoms: Eye pruritus, Eye swelling, Ocular hyperaemia, Swelling face
Clinical narrative: After receiving the seasonal influenza vaccine from a work place event, patient started having itching and swelling in her eyes. States the swelling became so bad that she needed to seek medical attention. Patient reports that this has happened over the last two previous years since getting the flu vaccine from workplace. Investigating the flu vaccines that she received over the last three years, the vaccine received were all from ID Biomedical. The list of adverse side effects are indeed: Grade 3 reddened eyes and Grade 3 facial swelling which she has experienced over the last 3 years. Each year after exposure, the symptoms worsened.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: lip and eyelid swelling
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Swelling of eyelid
Clinical narrative: lip and eyelid swelling
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: No adverse event; Office manager in a medical office reported that a patient received expired VARIVAX on 10/23/2024.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from an other (office manager) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 23-OCT-2024, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX), formulation:injection, lot # W031811, expiration date: 05-OCT-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Office manager in a medical office reported that a patient received expired VARIVAX on 10/23/2024.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from an other (office manager) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 23-OCT-2024, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX), formulation:injection, lot # W031811, expiration date: 05-OCT-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events were reported (no adverse event).
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3, MENB, COVID19, FLU3, MENB
Symptoms: Throat tightness
Clinical narrative: Patient had an anaphylaxis reaction outside the medical facility within two hours of vaccines but within ten minutes of ingesting a beverage with possible dairy cross contamination.  She was given epinephrine and treated in the Emergency Room with steroid and antihistamine and did well -- discharged home and has remained well.
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3, MENB, COVID19, FLU3, MENB
Symptoms: Anaphylactic reaction
Clinical narrative: Patient had an anaphylaxis reaction outside the medical facility within two hours of vaccines but within ten minutes of ingesting a beverage with possible dairy cross contamination.  She was given epinephrine and treated in the Emergency Room with steroid and antihistamine and did well -- discharged home and has remained well.
Age: 63.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: a pediatric dose of VAQTA was inadvertently administered to a 63 year old patient instead of an adult dose; No additional AE; This spontaneous report as received from a medical assistant refers to a 63-year-old patient.  Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot #, expiration date, exact dose and route of administration not provided) instead of an adult dose (incorrect dose administered). No adverse event was reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or symptoms reported; PNEUMOVAX 23 was administered after expiration date. Caller states the product expired 10/07/2024 and was administered to one patient 10/22/2024; This spontaneous report was received from a registered nurse and refers to a 66-year-old female patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not repoted.    On 22-OCT-2024, the patient was vaccinated with an expire dose of pneumococcal 23v polysaccharide vaccine(PNEUMOVAX23), lot # W029533, expiration date 07-OCT-2024, for prophylaxis (dose number and route were not reported) (expired product administered). No side effects or symptoms reported. The nurse verified the product has not had a temperature excursion. No Additional adverse events and product quality complaint were reported.  Additional information is expected.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; HCP calling to report an AE regarding the GARDASIL 9 vaccine. HCP stated that the GARDASIL 9 expired on 10/20/2024 and was inadverntly administered to a patient on 10/24/2024.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-OCT-2024, the patient was inadvertently vaccinated with and expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, valid lot #W021492, expiration date reported and confirmed as 20-OCT-2024, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). It was also informed that the suspect vaccine did not experience any prior temperature excursion. No additional adverse event reported (no adverse event).  This is non-valid report due to lack of patient's identifiers.  Follow-up information has been received on 06-NOV-2024 from a Nurse. On 06-NOV-2024, the reporting nurse confirmed that the report was about a 11-years-old male patient who on 24-OCT-2024, was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) by intramuscular route in the left deltoid for prophylaxis. On the same date, he was vaccinated with influenza vaccine(INFLUENZA) and meningococcal vaccine a/c/y/w conj (crm197)(MENVEO). It was reported that the patient had no reaction to the vaccine expired 4 days before the administration. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was ordered to the patient on 10-OCT-2024 and the physician finally consider that no revaccination was required. No more information was reported. This report previously considered as non-valid due top lack of patient's identifiers now, on 06-NOV-2024, became to be valid.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Medical Assistant calling with a report of an adverse event regarding improperly stored and administered PROQUAD.  Medical Assistant stated that a dose of PROQUAD was administered after it had been through a temperature excursion and reported the adm; This spontaneous report was received from an other health care professional (medical assistant) refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 18-OCT-2024 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # Y011214, expiration date: 18-DEC-2025, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion (product storage error). No additional adverse event reported (no adverse event).
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inbound call from HCP calling to report inadvertent administration of GARDASIL-9 to a 8 year old child.  HCP stated that the patient is 7 months away from being 9 years old.   Caller states that there are no symptomatic adverse events reported at thi; No adverse event; This spontaneous report was received from a consumer refers to a 8-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age, the patient was 7 months away from being 9 years old). No additional adverse event reported (no adverse event).