chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Electrocardiogram, Feeling abnormal, Fibrin D dimer, Heart rate increased, Hypertension
Clinical narrative: 6 days after receiving the RSV vaccine  suddenly felt strange and then a few seconds later my  Apple Watch alarmed that I was in atrial fib.  Check my pulse and I was in atrial fib at a rate of 80 bpm.  Had no chest pain and had no SOB.  Soon my pulse rate increased and I  called 911 and when the Paramedics arrived my heart rate was 150 in atrial fib.  Taken to Hospital. Had blood work drawn, IV started and several EKGs.  Spent about 9 hours there.  Highest B/P was 180/106.  Never had hypertension or atrial fib before.  Over the hospital course my heart rate slowly came down but was in atrial fib.  Went to CAT scan with contrast and was found to have 3 pulmonary emboli.  Started on Eliquis 10 mg BID for 7 days then 5 mg BID for the rest of my life and also started on Metoprolol 50 mg qd which 2 days later was back at ER with bradycardia of 48 and very lightheadedness. Had multiple labs done and then sent home with Metoprolol dose reduced to 25 mg qd
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Pulmonary embolism, Scan with contrast abnormal
Clinical narrative: 6 days after receiving the RSV vaccine  suddenly felt strange and then a few seconds later my  Apple Watch alarmed that I was in atrial fib.  Check my pulse and I was in atrial fib at a rate of 80 bpm.  Had no chest pain and had no SOB.  Soon my pulse rate increased and I  called 911 and when the Paramedics arrived my heart rate was 150 in atrial fib.  Taken to Hospital. Had blood work drawn, IV started and several EKGs.  Spent about 9 hours there.  Highest B/P was 180/106.  Never had hypertension or atrial fib before.  Over the hospital course my heart rate slowly came down but was in atrial fib.  Went to CAT scan with contrast and was found to have 3 pulmonary emboli.  Started on Eliquis 10 mg BID for 7 days then 5 mg BID for the rest of my life and also started on Metoprolol 50 mg qd which 2 days later was back at ER with bradycardia of 48 and very lightheadedness. Had multiple labs done and then sent home with Metoprolol dose reduced to 25 mg qd
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: Some of the vaccine leaked out of syringe during administration. Checked site for guidance and reached out to CDC, but CDC closed. Patient is willing to return for revaccination if required once confirmed.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Central nervous system lesion, Dysphagia, Ear pain, Hemiparesis
Clinical narrative: On 8/23 This patient's history began with an earache and the diagnosis of strep upper respiratory infection.  A day later the patient developed a Bell's palsy of the right side.  Within days the patient was being admitted to the hospital with neurological compromise, dysphagia, sepsis, right-sided hemiparesis
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Nervous system disorder, Sepsis, Streptococcal infection, Upper respiratory tract infection
Clinical narrative: On 8/23 This patient's history began with an earache and the diagnosis of strep upper respiratory infection.  A day later the patient developed a Bell's palsy of the right side.  Within days the patient was being admitted to the hospital with neurological compromise, dysphagia, sepsis, right-sided hemiparesis
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphasia, Brain fog, Thinking abnormal
Clinical narrative: for approximately 12 days after the injection, I couldn't think clearly...a minor "brain fog." For example I had trouble with word choices, thinking through the day to plan multiple events. I've never experienced that after a Covid vaccine or booster, just this SpikeVax.  And I have never had problems with word choice or planning my day, this was quite unusual.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Infusion, Mobility decreased, Pain in extremity, Wheelchair user
Clinical narrative: Numbness, extreme pain in extremities worsening until diagnosis and infusion start up Feb 2023.  Now in wheelchair because of mobility issues Treatment gammagard infusions
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the Shingrix vaccine, despite not being age 50 yet (1 month shy).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: about 36 hours after the injection, the patient complained of a sore arm at the injection site and then noticed a red swollen area a few inches below and towards the middle to inner side of the bicep on the injection site arm.  as of today 10-15-23, the red area is not swollen but was very itchy and slightly warm
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Cold sweat, Fatigue, Malaise, Pallor, Tension
Clinical narrative: As needle was withdrawn, patient put her head back and tensed up for approximately 10 seconds.  Appeared pale and clammy.  Stated she felt tired and didn't feel well.  Remained seated for approximately 15 minutes before she felt well enough to leave.  We gave her cold water and a wet washcloth to apply to forehead before she stood up.  Was able to walk out of the store with the escort of her partner.  Per partner, patient hit her head very hard the previous day - was experiencing nausea prior to receiving her vaccination.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Patient started having a severe nose bleed almost instantaneously after receiving the Spikevax vaccine in her left deltoid. Bleeding continued and I was not able to administered the second vaccine the patient had requested as a result (Flu vaccine). Patient continued bleeding for a few minutes despite her attempts to pinch her nose and lean forward. Blood spilled on the floor in the IMZ panel and some also splattered on IMZ cart. Emergency services and code white was called. Maintenance and club management assisted with the clean up of the blood spill and EMTs administered Afrin to patient and stretchered her out of the facility to the ER. Called patient at 3:19 pm, patient was home and doing well. She said she was informed at the hospital that the nosebleed was most likely the result of a combination of seasonal allergies which dried out her nasal membrane lining and high blood pressure. She was discharged after providing instructions on what to do if it happens again. Patient was very grateful for the follow up and all the assistance the pharmacy and  the store management and associates provided her and calling emergency services in a timely manner.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Sweating, felt like she was about to faint
Age: 63.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Malaise, Mobility decreased, Nausea
Clinical narrative: nausea and general malaise occuring evening and next morning after vaccines requiring patient to stay in bed
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Influenza vaccine administered instead of Tdap on 10/10/2023. Recently received quad influenza vaccine on 10/2/2023.
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Arthralgia, Diarrhoea, Headache, Migraine, Oropharyngeal pain
Clinical narrative: 3 am  had joint pain and headache, sore throat that kept me awake. Around 9:30 am started having a  headache that I think was a migraine (I've never had them before).  It was so bad I had to go to a dark room and place a cold wash rag on my eyes and head. I then vomited several times and had diarrhea.  After spending all afternoon in the dark room I now have a dull headache .
Age: 66.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Photophobia, Vomiting
Clinical narrative: 3 am  had joint pain and headache, sore throat that kept me awake. Around 9:30 am started having a  headache that I think was a migraine (I've never had them before).  It was so bad I had to go to a dark room and place a cold wash rag on my eyes and head. I then vomited several times and had diarrhea.  After spending all afternoon in the dark room I now have a dull headache .
Age: 39.0
Sex: M
Vaccine: COVID19, FLUR4, HPV9
Symptoms: Anaphylactic reaction, Eye movement disorder, Fatigue, Feeling hot, Loss of consciousness
Clinical narrative: PATIENT GOT AN ANAPHALAXIS 2 MINUTES AFTER RECEIVING THE 3 VACCINES. HE ALREADY ATE. HE FELT HOT AND WAS SHAKING AND ROLLING HIS EYE. WE CALLED CODE WHITE AND 911. HE BECAME COMPLETEPY UNCONCIOUSNESS AFTER 1-2 MINUTES. WE TRY TO WAKE HIM UP BUT NO RESPONSE. I INJECTED  EPIPEN IN HIS THIGH. HIS WIFE WAS HOLDING HIM AND FELT HE WAS RESPONDING AFTER THE INJECTION. HE SLOWLY REGAIN CONCIOUSNESS AFTER 1 MINUTES BUT STILL VERY TIRED. I MONITOR HIM UNTIL 911 CAME AND TOOK OVER. PT FELT BETTER AND REFUSE TO GO TO THE HOSPITAL
Age: 39.0
Sex: M
Vaccine: COVID19, FLUR4, HPV9
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: PATIENT GOT AN ANAPHALAXIS 2 MINUTES AFTER RECEIVING THE 3 VACCINES. HE ALREADY ATE. HE FELT HOT AND WAS SHAKING AND ROLLING HIS EYE. WE CALLED CODE WHITE AND 911. HE BECAME COMPLETEPY UNCONCIOUSNESS AFTER 1-2 MINUTES. WE TRY TO WAKE HIM UP BUT NO RESPONSE. I INJECTED  EPIPEN IN HIS THIGH. HIS WIFE WAS HOLDING HIM AND FELT HE WAS RESPONDING AFTER THE INJECTION. HE SLOWLY REGAIN CONCIOUSNESS AFTER 1 MINUTES BUT STILL VERY TIRED. I MONITOR HIM UNTIL 911 CAME AND TOOK OVER. PT FELT BETTER AND REFUSE TO GO TO THE HOSPITAL
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: I received the latest COVID-19 booster shot on Tuesday, October 3, 2023 at 2:00 pm. An hour later I felt very cold. I put on three layers of sweaters, but I was still shivering, and my teeth were chattering. No matter what I did I could not warm up. That lasted for about 8 hours. After that I still felt a little cold, but I could warm up with one sweater. That phase went on for about another 12 hours. During this time my body felt tired, and I was low energy.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Injection site bruising, Myalgia
Clinical narrative: Fatigue, muscle soreness, feeling warm and bruising at the vaccination injection site. I?ve tried to drink water and have taken ibuprofen.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Constant arm pain since injection, loss of range of motion
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Pyrexia
Clinical narrative: Fever to 102 for 72 hrs and loss of smell starting during fever and continues currently
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Back pain, Fatigue, Headache, Myalgia
Clinical narrative: Headache, fatigue, myalgia, lower back pain
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Brain fog, Condition aggravated, Epstein-Barr virus antibody positive
Clinical narrative: Extreme exhaustion/fatigue, extreme joint pain,  exhaustion upon rising in the am, constantly resting/napping, brain fog when energy is depleted
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Epstein-Barr virus infection, Fatigue
Clinical narrative: Extreme exhaustion/fatigue, extreme joint pain,  exhaustion upon rising in the am, constantly resting/napping, brain fog when energy is depleted
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 3 boosters
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site rash
Clinical narrative: Large red itchy rash at site of vaccine.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. presented w/ large hot red area 3" x 4" on Bicep   s/w pt this am (10/15) swelling seems to be subsiding
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Antibody test, Antinuclear antibody, Blood folate, Blood thyroid stimulating hormone, Dysarthria
Clinical narrative: Began to have trouble speaking soon after the Covid vaccination. Speech was slower, she said it was harder to pronounce consonants. In January, went to the nurse practioner who saw muscle twitching, and gave a tentative diagnosis of bulbar onset ALS. Speech & swallowing became more difficult. In May saw a neurologist who diagnosed ALS with nerve conduction tests. Eating became difficult so in early June had a PEG tube inserted. Saw neurologist at Medical CenterALS confirmed. Feedings kept weight at 20 lbs. less than her previous weight, but picked up a C-Diff infection. Began using a NIV to breathe and became dependent on it by Aug.  Became weaker but still walking at time of death on August 8,
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Dysphagia, Facial paresis, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: Began to have trouble speaking soon after the Covid vaccination. Speech was slower, she said it was harder to pronounce consonants. In January, went to the nurse practioner who saw muscle twitching, and gave a tentative diagnosis of bulbar onset ALS. Speech & swallowing became more difficult. In May saw a neurologist who diagnosed ALS with nerve conduction tests. Eating became difficult so in early June had a PEG tube inserted. Saw neurologist at Medical CenterALS confirmed. Feedings kept weight at 20 lbs. less than her previous weight, but picked up a C-Diff infection. Began using a NIV to breathe and became dependent on it by Aug.  Became weaker but still walking at time of death on August 8,
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Muscle twitching, Red blood cell sedimentation rate, Vitamin B12
Clinical narrative: Began to have trouble speaking soon after the Covid vaccination. Speech was slower, she said it was harder to pronounce consonants. In January, went to the nurse practioner who saw muscle twitching, and gave a tentative diagnosis of bulbar onset ALS. Speech & swallowing became more difficult. In May saw a neurologist who diagnosed ALS with nerve conduction tests. Eating became difficult so in early June had a PEG tube inserted. Saw neurologist at Medical CenterALS confirmed. Feedings kept weight at 20 lbs. less than her previous weight, but picked up a C-Diff infection. Began using a NIV to breathe and became dependent on it by Aug.  Became weaker but still walking at time of death on August 8,
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Amyotrophic lateral sclerosis, Asthenia, Blood test, Clostridium difficile infection, Death
Clinical narrative: Began to have trouble speaking soon after the Covid vaccination. Speech was slower, she said it was harder to pronounce consonants. In January, went to the nurse practioner who saw muscle twitching, and gave a tentative diagnosis of bulbar onset ALS. Speech & swallowing became more difficult. In May saw a neurologist who diagnosed ALS with nerve conduction tests. Eating became difficult so in early June had a PEG tube inserted. Saw neurologist at Medical CenterALS confirmed. Feedings kept weight at 20 lbs. less than her previous weight, but picked up a C-Diff infection. Began using a NIV to breathe and became dependent on it by Aug.  Became weaker but still walking at time of death on August 8,
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Dysphagia, Eating disorder, Gastrostomy, Magnetic resonance imaging, Mechanical ventilation
Clinical narrative: Began to have trouble speaking soon after the Covid vaccination. Speech was slower, she said it was harder to pronounce consonants. In January, went to the nurse practioner who saw muscle twitching, and gave a tentative diagnosis of bulbar onset ALS. Speech & swallowing became more difficult. In May saw a neurologist who diagnosed ALS with nerve conduction tests. Eating became difficult so in early June had a PEG tube inserted. Saw neurologist at Medical CenterALS confirmed. Feedings kept weight at 20 lbs. less than her previous weight, but picked up a C-Diff infection. Began using a NIV to breathe and became dependent on it by Aug.  Became weaker but still walking at time of death on August 8,
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Muscle twitching, Nerve conduction studies, Slow speech, Speech disorder, Weight decreased
Clinical narrative: Began to have trouble speaking soon after the Covid vaccination. Speech was slower, she said it was harder to pronounce consonants. In January, went to the nurse practioner who saw muscle twitching, and gave a tentative diagnosis of bulbar onset ALS. Speech & swallowing became more difficult. In May saw a neurologist who diagnosed ALS with nerve conduction tests. Eating became difficult so in early June had a PEG tube inserted. Saw neurologist at Medical CenterALS confirmed. Feedings kept weight at 20 lbs. less than her previous weight, but picked up a C-Diff infection. Began using a NIV to breathe and became dependent on it by Aug.  Became weaker but still walking at time of death on August 8,
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13, DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Irritability, Rash erythematous, Skin discolouration
Clinical narrative: Within one hour of vaccination, mother noted a rash on both thighs resembling "acne"
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13, DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site rash
Clinical narrative: Within one hour of vaccination, mother noted a rash on both thighs resembling "acne"
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Very sore arm at the injections site, followed by a rash, raised bumps, inflamed, upper arm, itchy. Inflammation covered upper arm from shoulder to just above the elbow.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site inflammation, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Very sore arm at the injections site, followed by a rash, raised bumps, inflamed, upper arm, itchy. Inflammation covered upper arm from shoulder to just above the elbow.
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Erythema, Feeling abnormal, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: pain when given and hurt to shoulder for 10 minutes, sore arm. Everyday after arm  was swelling more, hot to touch and hurt. Oct 11 went to see doctor and had to get prednisone. Was warned to watch closely because of the servere reaction I was having.
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Pyrexia
Clinical narrative: pain when given and hurt to shoulder for 10 minutes, sore arm. Everyday after arm  was swelling more, hot to touch and hurt. Oct 11 went to see doctor and had to get prednisone. Was warned to watch closely because of the servere reaction I was having.
Age: 71.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: pain when given and hurt to shoulder for 10 minutes, sore arm. Everyday after arm  was swelling more, hot to touch and hurt. Oct 11 went to see doctor and had to get prednisone. Was warned to watch closely because of the servere reaction I was having.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Crepitations, Laboratory test, Memory impairment
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Basophil count, Basophil percentage
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Bilirubin conjugated abnormal, Bilirubin urine, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium, Blood sodium decreased
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Blood urea normal, Bordetella test negative, Carbon dioxide decreased, Confusional state, Coronavirus test negative
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Delirium, Enterovirus test negative, Eosinophil count, Eosinophil percentage decreased, Glomerular filtration rate
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Glucose urine absent, Haematocrit decreased, Haemoglobin decreased, Human metapneumovirus test, Human rhinovirus test
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Immature granulocyte count, Influenza A virus test negative, Influenza B virus test, Lipase, Liver function test
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Lymphocyte count, Lymphocyte percentage decreased, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Monocyte count, Monocyte percentage, Neutrophil count, Neutrophil percentage increased, Nitrite urine absent
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Nucleated red cells, Platelet count normal, Protein total normal, Protein urine absent, Red blood cell count decreased
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Red blood cells urine, Red cell distribution width normal, Respiratory pathogen panel, Respiratory syncytial virus test negative, Respirovirus test negative
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Restlessness, Rubulavirus test negative, SARS-CoV-2 test, Specific gravity urine normal, Urine ketone body present
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Urobilinogen urine, White blood cell count normal, White blood cells urine, White blood cells urine negative, pH urine normal
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2, COVID19, COVID19
Symptoms: Confusional state, Head discomfort, Memory impairment
Clinical narrative: Patient went to ED for increased confusion. Intermittently confused, restless, delirious overnight after covid vaccine.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Overdose, Wrong product administered
Clinical narrative: LLT no adverse effect; Wrong vaccine administered; Vaccine overdose; This spontaneous report was received from company Representative and referred to his 2 child of unknown gender, just turned 1 year old.  Concomitant medications included sterile diluent. The patient's concurrent conditions, medical history, and historical drugs were not reported.  On 19-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection; and  varicella virus vaccine live (oka/merck) (VARIVAX) injection,  (strength, dose description, lot #, expiry date, route of administration, and indication were not provided), so in essence they received an extra dose of the varicella component (overdose) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and  varicella virus vaccine live (oka/merck) (VARIVAX) (Wrong product administered) by mistake. They did not noticed any untoward effects (no adverse event).  This is one of 2 reports received from the same reporter.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Overdose, Wrong product administered
Clinical narrative: LLT no adverse effect; Wrong vaccine administered; Vaccine overdose; This spontaneous report was received from company Representative and referred to his 2 child of unknown gender, just turned 1 year old.  Concomitant medications included sterile diluent. The patient's concurrent conditions, medical history, and historical drugs were not reported.  On 19-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection; and  varicella virus vaccine live (oka/merck) (VARIVAX) injection,  (strength, dose description, lot #, expiry date, route of administration, and indication were not provided), so in essence they received an extra dose of the varicella component (overdose) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and  varicella virus vaccine live (oka/merck) (VARIVAX) (Wrong product administered) by mistake. They did not noticed any untoward effects (no adverse event).  This is one of 2 reports received from the same reporter.
Sex: U
Vaccine: MEN, TDAP
Symptoms: Rash
Clinical narrative: Developed rash; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of rash in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included MENQUADFI for prophylaxis.   On an unknown date, the patient received Boostrix and MENQUADFI. On an unknown date, an unknown time after receiving Boostrix, the patient experienced rash (Verbatim: Developed rash).The outcome of the rash was resolved.   It was unknown if the reporter considered the rash to be related to Boostrix.  It was unknown if the company considered the rash to be related to Boostrix.   Additional Information: GSK Receipt Date:05-OCT-2023 The initial information received on 28-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involved a patient of an unknown age and gender who experienced rash after receiving vaccines Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Boostrix) and Meningococcal A-C- Y- W 135 (T conj) Vaccine (Menquadfi).  The patient's past medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received an unknown dose of suspects Meningococcal A-C-Y-W 135 (T Conj)vaccine solution for injection and Boostrix (formulation: unknown) not produced by Sanofi Pasteur both with unknown strength, expiry date and lot number via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed rash (unknown latency).  The information on the batch number was requested. It was not reported if patient received corrective treatment. At the time of reporting, the outcome was recovered/resolved on an unknown date for an event. It was unknown if reporter considered rash to be related to Menquadfi. This case was linked to case 2023SA265313.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, Product packaging issue
Clinical narrative: patient received a lower amount of the vaccine; product is packaged without needles; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2023-2024 season) (batch number 5ME77, expiry date 30-JUN-2024) for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2023-2024 season. On an unknown date, an unknown time after receiving Fluarix Tetra 2023-2024 season, the patient experienced incomplete dose administered (Verbatim: patient received a lower amount of the vaccine) and product packaging issue (Verbatim: product is packaged without needles).The outcome of the incomplete dose administered and product packaging issue were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 04-OCT-2023 The reporter called and reported that a pediatrician told them that whilst administering a dose of Fluarix, the needle suffered leakage and the patient received a lower amount of the vaccine, which led to incomplete dose administered. They gave partial information about the event and also gave the healthcare professional information. The reporter reported that the product was packaged without needles, which led to product packaging issue. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: The same patient received both Boostrix and Menveo(1 vial) in the office yesterday on 10/4/23; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 54CP2, expiry date 11-JAN-2026) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 52X45, expiry date 31-DEC-2024) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX) and MENVEO.   On 04-OCT-2023, the patient received Boostrix and Menveo. On 04-OCT-2023, an unknown time after receiving Boostrix and Menveo, the patient experienced extra dose administered (Verbatim: The same patient received both Boostrix and Menveo(1 vial) in the office yesterday on 10/4/23).The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-OCT-2023 The RN (registered nurse) reported a 11-year-old patient received Boostrix and Menveo (2 vial) back on 29-AUG-2023. The same patient received both Boostrix and Menveo (1 vial) in the office yesterday (day before reporting), which led to extra dose administered. The reporter called to inquire and asked was there any information available and how to proceed. The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired FLUZONE HIGH DOSE was accidentally administered to a patient (with no adverse event); Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 66 years old female patient who received expired Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] accidentally (with no adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2023, the patient received expired dose of 0.7 ml suspect Influenza Quadrival A-B High Dose Hv Vaccine (strength, formulation and expiry date : unknown, lot UT7743CA) via intramuscular route in the left deltoid as immunization (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered a act-hib that was expired on 13August2023 no adverse event; Initial information was received on 06-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age of patient was administered hib (prp/t) vaccine [ACT-HIB] that was expired on 13august2023 no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot UJ756AA, strength was unknown, expiry date : 13-Aug-2023) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient was administered a act-hib that was expired on 13august2023 no adverse event (expired product administered) (latency: same day).  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered a act-hib that was expired on 13august2023 no adverse 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.
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: fluzone hd qiv following administration to a patient today 09oct2023, who just received the same vaccine 4 weeks ago with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient for whom influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] following administration today 09oct2023, who just received the same vaccine 4 weeks ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (with an unknown strength and formulation) (lot U8138DA, expiry date- 30-JUN-2024) via unknown route in unknown administration site for Immunization who just received the same vaccine 4 weeks ago with no reported adverse event (inappropriate schedule of product administration) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was 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: 0.67
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: FLUZONE QUADRIVALENT  twicely which is just 3 weeks apart  with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA311407(CLUSTER).  This case involves a 8 months old female patient who received influenza quadrival A-B vaccine [Fluzone Quadrivalent] twicely which is just 3 weeks apart with no reported adverse event.  The patient's past vaccination(s) included Fluzone Quadrivalent on 16-SEP-2023.  The patient's past medical history, medical treatment(s) and family history were not provided.  On 07-Oct-2023, the patient received a dose 2 of suspect Influenza Quadrival A-B Vaccine Suspension for injection lot UT8144LA expiry date: 30-jun-2024 via unknown route in unknown administration site for prophylactic vaccination (immunization) and fluzone quadrivalent  twicely which is just 3 weeks apart  with no reported adverse event (inappropriate schedule of product administration) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone quadrivalent  twicely which is just 3 weeks apart  with no reported adverse 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: 0.17
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of ACTHIB was inadvertently administered with no adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 2 months old male patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] inadvertently with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination (immunization); and Diphtheria vaccine Toxoid, Hepatitis B vaccine RHBSAG (YEAST), Pertussis vaccine Acellular 3-Component, Polio vaccine INACT 3V (VERO), Tetanus vaccine toxoid (PEDIARIX) for Immunisation.  On 09-Oct-2023, the patient received 0.5 ml expired dose (dose 1) (frequency: once; strength: Standard) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UJ792AA and expiry: 06-Oct-2023 via intramuscular route in the left thigh for immunization, with no reported adverse event (expired product administered) (Latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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: 0.5
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: stated that the vaccine expired on 10/1 and was administered to a child today 10/9 with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 6-months-old male patient who was administered diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] today (10/9) that had expired on 10/1 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant: none.  On 09-Oct-2023, the patient received 0.5 mL expired dose 3 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (Strength: standard; Frequency: once) (batch number: UJ807AA; expiry date: 01-Oct-2023) via intramuscular route in the right thigh for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was 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: 1.75
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACT-HIB dose was administered to a patient with no adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 21-months-old and unknown gender patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Oct-2023, the patient received an unknown expired dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ792AA; expiry date: 06-Oct-2023) (Strength: standard; Frequency: Once) via unknown route in unknown administration site for Immunization with no adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  No additional information available at time of call; caller declined to respond to questions and has accepted follow-up.  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: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Computerised tomogram head, Facial paralysis, Laboratory test, Scan with contrast
Clinical narrative: Bell?s palsy - left sided face paralysis  TX; Val acyclovir & prednisone  for 1 week Hope to recover in the coming months.
Sex: F
Vaccine: UNK
Symptoms: Chills, Dermatitis acneiform, Headache
Clinical narrative: rash; headache; chills; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash), CHILLS (chills) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2023 at 12:30 PM, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Oct-2023, the patient experienced CHILLS (chills). On 10-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEADACHE (headache). On an unknown date, the patient experienced RASH (rash). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. At the time of the report, RASH (rash), CHILLS (chills) and HEADACHE (headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient reported that a rash had developed all over her breasts, chest area, armpits spine, there a large patch there under both armpits. This happened 48 hours after receiving the shot or might be it was already there before, and she did not realize until 11-Oct-2023. The first night she had chills.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Incorrect dose administered, Medication error, No adverse event
Clinical narrative: Patient got her High Dose Flu shot today and when the nurse dispensed the flu shot, it dripped on her arm and she may not have gotten the full dose with no reported adverse event; Patient got her High Dose Flu shot today and when the nurse dispensed the flu shot, it dripped on her arm with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 67 years old female patient who got her influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] high dose flu shot today and when the nurse dispensed the flu shot, it dripped on her arm and she may not have gotten the full dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2023, the patient received 0.7 ml (once) dose of suspect  influenza quadrival A-B high dose HV vaccine, (strength, formulation, dose, route, batch number and expiry date: unknown) via unknown route in the arm nos (not otherwise specified) for immunization when the nurse dispensed the flu shot, it dripped on her arm and she may not have gotten the full dose with no reported adverse event (incorrect dose administered) (accidental exposure to product) (latency: same day).  Action taken: not applicable.  Outcome :  Unknown.   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.