chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event, Wrong technique in product usage process
Clinical narrative: hib part of the vaccine must be administered as soon as possible, but the provider administered the hib part after a month from the date that the dtap-ipv portion was administered with no reported adverse event; the patient received his second dose of PENTACEL instead of the eight week mark with no reported adverse event; inadvertently received only the DTAP-IPV part of PENTACEL with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 134 days old male patient who inadvertently received only the dtap-ipv part of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) VACCINE [Pentacel (vero) with no reported adverse event, hib part of the vaccine must be administered as soon as possible, but the provider administered the hib part after a month from the date that the dtap-ipv portion was administered with no reported adverse event and the patient received his second dose of pentacel instead of the eight week mark with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Aug-2023, the patient received 0.5 ml dose 1 of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (incorrect dose administered) (latency- same day) On 18-Oct-2023 he also received a dose 2 of the same vaccine  with an unknown batch number via unknown route in unknown administration site (strength, lot/batch number and expiration date: not provided) for immunization (wrong technique in product usage process) and (inappropriate schedule of product administration) (latency- same day). Information on the batch number was requested.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for all the events.  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: Medication error, No adverse event, Product storage error
Clinical narrative: Pre-filled syringes were placed in the cooler, reported a temperature below 0°C, Human error: Yes Duration of excursion: 1 hour with no reported adverse event; products been administered post excursion patients with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 86 patients of unknown age and demographics who were administered Influenza Quadrival A-B vaccine [FLUZONE QUADRIVALENT] post excursion where pre-filled syringes were placed in the cooler, reported a temperature below 0°c, human error: yes duration of excursion: 1 hour with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Oct-2023, the patients received an unknown dose of suspect Influenza Quadrival A-B vaccine Suspension for injection of lot UT8040JA and expiry: 30-Jun-2024 via unknown route in unknown administration site for immunization.  On an unknown date, it was reported that the pre-filled syringes of Influenza Quadrival A-B vaccine were placed in the cooler, reported a temperature below 0°C, human error: yes duration of excursion: 1 hour with no reported adverse event (product storage error) (unknown latency).  On 13-Oct-2023, the patient had been administered Influenza Quadrival A-B vaccine post excursion patients with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was reported.  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: 24.0
Sex: F
Vaccine: UNK
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a 24-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3835D) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 20-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) was resolving.            Concomitant medication was not reported.  It was unknown if the patient experienced any additional symptoms/events.   Treatment information was not provided.   Reporter did not allow further contact
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired dose of pentacel was administered to a 13 month old patient with no reported adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 month old male patient and reporter reported that expired dose of diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib (PRP/T) Vaccine [Pentacel (Vero)] was administered to a 13 month old patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad)  On 16-Oct-2023, the patient received a expired dose 4 at a dose of 0.5 ml of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib (PRP/T) Vaccine Suspension for injection (strength: unknown, expiry date: 01-Oct-2023 and lot UJ807AA) via intramuscular route in the right thigh (Vastus Lateralis) 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.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient had been administered with an expired dose of TENIVAC with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 60 years old female patient who had been administered with an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Oct-2023, the patient received 0.5 ml total (1X) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection (lot number: U7183AA) (Expiry date: 24-Sep-2023) (Strength: standard) (Frequency: once) via intramuscular route in the left deltoid for immunization.  On 18-Oct-2023, the patient had been administered with an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse event (expired product administered) (latency: same day).   It was reported, Medical assistant called to ask about precautions that they need look out for as well as if the vaccine needs to be repeated after a patient had been administered with an expired dose of TENIVAC. This situation is reported as a medication error due to administration of expired medication. No adverse reactions has been reported by the patient.  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 and Regulatory Authority 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Dizziness, Heart rate increased, Hyperhidrosis, Palpitations
Clinical narrative: heart palpitations, dizziness, sweating, rapid heartbeat, unable to relax
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: heart palpitations, dizziness, sweating, rapid heartbeat, unable to relax
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Myocarditis
Clinical narrative: myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in a 29-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Had myocarditis from Covid vaccine. It was a very different story. A 29 year old male with a young child, who can't work, limited whole body function, currently looking at blood transfusions, hospitals in disarray because they don't know what to do.  No treatment medications were provided.  Company Comment This spontaneous case concerns a 29 years-old male patient with no medical history reported who experienced the expected seriousness criterion medically significant event of myocarditis unknown days after a dose of mRNA-1273.815 vaccine. Concomitant medication details nor Treatment details were reported The benefit-risk relationship of mRNA-1273.815 vaccine  is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2023: Live follow up received contains new reporter added.
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administration post excursion (with no reported adverse event); products were exposed to a temperature of 17 degrees Fahrenheit and were out of range for a total of about 5 hours over a 24 hour period (with no reported adverse event); Initial information was received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient of influenza quadrival a-b vaccine [Fluzone QIV] products were exposed to a temperature of 17 degrees fahrenheit and were out of range for a total of about 5 hours over a 24 hour period (with no reported adverse event) and administration post excursion (with no reported adverse event).  It was reported that unknown dose of suspect influenza quadrival a-b vaccine (Suspension for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination(Immunization). There will be no information available on batch number for this case.  On 13-Oct-2023 the patient reported that products were exposed to a temperature of 17 degrees fahrenheit and were out of range for a total of about 5 hours over a 24 hour period (with no reported adverse event) (product storage error) (unknown latency) following the administration of influenza quadrival a-b vaccine. On an unknown date the patient reported that administration post excursion (with no reported adverse event) (poor quality product administered) (latency: same day).  Reportedly "Caller stated the cause of the excursions were from the refrigerator temperatures dropping. He did not provide any other specifics. Notified the caller that the extended stability information does not cover an excursion of this length and/or temperature, and the dispensing of the products is no longer supported. After we notified the caller that any exposure below freezing would make the products not viable for use, he stated one of the vaccines had been administered, and asked what to do regarding that. Only pt information the caller could provide us with at the time was that they were a male pt. "  Action taken with QUADRIVALENT influenza vaccine (Fluzone QIV) was not applicable.  At time of reporting, the outcome was Unknown for the event products were exposed to a temperature of 17 degrees fahrenheit and were out of range for a total of about 5 hours over a 24 hour period (with no reported adverse event) and was Unknown for the event administration post excursion (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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Ear swelling, Flushing
Clinical narrative: Left arm soreness followed by nerve pain in bilateral upper extremities, upper mid back pain, chills, headache, weakness.  Alternating tylenol and motrin only mildly effective.  Greater than 24 hours s/p injection, continued headache, nerve pain.  Approximately 40 hours later developed raised measles like rash bilaterally above the knee and distal upper extremties (forearms), flushed face and eat lobe swelling.  Some improvement with 50mg oral benedryl and 1000mg tylenol.  If no symptomatic improvement, will seek urgent care for prednisone
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neuralgia, Pain in extremity, Rash, Rash morbilliform
Clinical narrative: Left arm soreness followed by nerve pain in bilateral upper extremities, upper mid back pain, chills, headache, weakness.  Alternating tylenol and motrin only mildly effective.  Greater than 24 hours s/p injection, continued headache, nerve pain.  Approximately 40 hours later developed raised measles like rash bilaterally above the knee and distal upper extremties (forearms), flushed face and eat lobe swelling.  Some improvement with 50mg oral benedryl and 1000mg tylenol.  If no symptomatic improvement, will seek urgent care for prednisone
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Left arm soreness followed by nerve pain in bilateral upper extremities, upper mid back pain, chills, headache, weakness.  Alternating tylenol and motrin only mildly effective.  Greater than 24 hours s/p injection, continued headache, nerve pain.  Approximately 40 hours later developed raised measles like rash bilaterally above the knee and distal upper extremties (forearms), flushed face and eat lobe swelling.  Some improvement with 50mg oral benedryl and 1000mg tylenol.  If no symptomatic improvement, will seek urgent care for prednisone
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Heart rate increased, Pain in extremity
Clinical narrative: Racing heartbeat waking from sleep 90 bpm increasing to 130 bpm. 130 bpm lasted 5?10 minutes, reducing to  88 bpm,  and reducing to 82bpm after two hours. Alternating chills and heat lasting 30 min. Current intermittent headache. Current very sore left arm.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Racing heartbeat waking from sleep 90 bpm increasing to 130 bpm. 130 bpm lasted 5?10 minutes, reducing to  88 bpm,  and reducing to 82bpm after two hours. Alternating chills and heat lasting 30 min. Current intermittent headache. Current very sore left arm.
Age: 74.0
Sex: F
Vaccine: RAB, RSV
Symptoms: Ascending flaccid paralysis, CSF glucose increased, CSF protein increased, Facial paralysis, Guillain-Barre syndrome
Clinical narrative: Onset 9/20/23 with numbness in 2 fingers, followed over next 5 days with lower leg & perioral numbness progressing to ascending paralysis of all 4 extremities and left facial paralysis. Diagnosis of Guillain-Barré Syndrome made on 9/25/23. Treated with IVIG 9/25-29/23. Currently recovering in rehabilitation facility
Age: 74.0
Sex: F
Vaccine: RAB, RSV
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy
Clinical narrative: Onset 9/20/23 with numbness in 2 fingers, followed over next 5 days with lower leg & perioral numbness progressing to ascending paralysis of all 4 extremities and left facial paralysis. Diagnosis of Guillain-Barré Syndrome made on 9/25/23. Treated with IVIG 9/25-29/23. Currently recovering in rehabilitation facility
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Balance disorder, Dizziness, Nausea, Vertigo
Clinical narrative: Approximately 12 hours after administration, dizzyness. Following morning, extreme dizzyness (room spinning) even while lying down. nauseous, vomiting, weakness. Continued for 3 days. Had virtual visit with PA-C. 2 prescriptions ordered. Meclizine and Ondansetron ODT. Condition somewhat improved but still 11 days later remaining unsteadiness and slightly dizzy
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: Approximately 12 hours after administration, dizzyness. Following morning, extreme dizzyness (room spinning) even while lying down. nauseous, vomiting, weakness. Continued for 3 days. Had virtual visit with PA-C. 2 prescriptions ordered. Meclizine and Ondansetron ODT. Condition somewhat improved but still 11 days later remaining unsteadiness and slightly dizzy
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Influenza, Limb discomfort, Pain
Clinical narrative: Received vaccine saturday 10/=1/23 at 1215 pm complained of sore right arm with swelling/red body aches saturday pm? Time. Sunday 10/22/23 complains of headache + flu symptoms. 10/23/23 at appt c/o (R) UE discomfort raised areas of erythema (R) bicep area 7cm x 9cm, warm and tender to touch. circumference of area on skin marked with blue pen/ink denied symptoms of headache or flu symptoms, continues with symptoms of warm and tender to touch ,swelling and erythema. nothing further.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Received vaccine saturday 10/=1/23 at 1215 pm complained of sore right arm with swelling/red body aches saturday pm? Time. Sunday 10/22/23 complains of headache + flu symptoms. 10/23/23 at appt c/o (R) UE discomfort raised areas of erythema (R) bicep area 7cm x 9cm, warm and tender to touch. circumference of area on skin marked with blue pen/ink denied symptoms of headache or flu symptoms, continues with symptoms of warm and tender to touch ,swelling and erythema. nothing further.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Patient was supposed to receive the meningococcal conjugate vaccine today, but nurse accidently gave the Meningococcal B vaccine (erythema/swelling at injection site, fatigue for a couple days-nausea headache, and diarrhea can also occur).  The vaccine dose is valid, but we will not give the 2nd dose of the meningococcal B (Bexsero) series until patient is of an appropriate age ( 16-17 yo).  Spoke with patients mother and patient will receive meningococcal conjugate vaccine at his next visits. (12 yo WCC).     Patient had no reaction per mother  "arms are a little sore".
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Wrong product administered
Clinical narrative: Patient was supposed to receive the meningococcal conjugate vaccine today, but nurse accidently gave the Meningococcal B vaccine (erythema/swelling at injection site, fatigue for a couple days-nausea headache, and diarrhea can also occur).  The vaccine dose is valid, but we will not give the 2nd dose of the meningococcal B (Bexsero) series until patient is of an appropriate age ( 16-17 yo).  Spoke with patients mother and patient will receive meningococcal conjugate vaccine at his next visits. (12 yo WCC).     Patient had no reaction per mother  "arms are a little sore".
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Disorganised speech, Fall, Loss of consciousness, Muscle contracture, Unresponsive to stimuli
Clinical narrative: At 1:30 am I woke up and decided to go to the restroom.  On my way back to bed, I passed out and landed on the floor next to the bed.  My husband heard the fall, tried to rouse me and, after a few minutes, was able to get me to sit upright.  I had no memory of feeling dizzy or lightheaded.  He went to get something in case I was nauseas and when he returned I was doubled over, passed out, with my right hand in a fish and my arm drawn up rigidly to my chest and completely unresponsive.  When I finally came to and tried to talk, it was unintelligible.  After a few minutes he was able to help me to bed.  I am a thin, athletic woman who, in general, is in excellent health.  When I took the 2nd of the initial 2 COVID vaccines several years ago, I also passed out twice.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: chills, fever (100.8 degrees), body aches, headache - lasting about 6 hours
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram, Joint range of motion decreased, Musculoskeletal stiffness, Pain, Sleep disorder
Clinical narrative: 4-5 days after TDAP vaccination was given. I develop a stiff arm like it is paralyze. from my shoulder to my hand specifically 4 and 5th finger. pain is worst at night time. wake up every night even until now because of pain.  at first, i was given toradol shots and oral steroid but only last for 3-5 days.I am now taking Gapabentin 300mg twice a day and an occupational therapy to have my range of motion back.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Administered flu vaccine during flu clinic for employees on 10/06/2023. On 10/23/2023 reported to Employee Health Services that arm was still painful. Submitted WC claim and sent to  Health clinic for eval.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Hypoxia
Clinical narrative: Admit to hospital for acute COVID-19 infection in patient with severe COPD. Hypoxic.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Delirium, Disorientation, Fall, Musculoskeletal injury
Clinical narrative: Acute delirium 12 hours after vaccination resulting in disorientation, fall, minor musculoskeletal injuries.  did not require hospitalization or ED visit.  Resolved after 2-3 hours rest
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Brain fog, Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Type of Flus shot administered is not known to me.  Patient reports episode of brain fog and fatigue as well as brief episode of fever, chills and sweats beginning a few hours after sot and lasting less than 12 hours. Patient requested this be reported.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Tinnitus
Clinical narrative: Staff member c/o dizziness, sweats, ringing in ear, vital signs 99%02 RA, rr 18, hr 120 BP 132/78 temp 98.1 po benadryl and tylenol given. EMS called. transferred to ER for further evaluation.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given vaccination by accident. Not due for vaccinations at the time.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Headache, Intraocular pressure test normal, Migraine
Clinical narrative: Within 30 min after, felt a hollow ear on my left side, but that only lasted a few minutes. The next morning, it felt like something hit my left eyeball or something popped in my left eyeball, then immediately saw a grey film over my left eye that lasted about 30 min then slowly went away. My left arm vase very painful, radiating up my neck to my jaw and temple. I proceeded to get a migraine type headache. There is a large swollen, red lump on my left arm 2 days later.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Ocular discomfort, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Within 30 min after, felt a hollow ear on my left side, but that only lasted a few minutes. The next morning, it felt like something hit my left eyeball or something popped in my left eyeball, then immediately saw a grey film over my left eye that lasted about 30 min then slowly went away. My left arm vase very painful, radiating up my neck to my jaw and temple. I proceeded to get a migraine type headache. There is a large swollen, red lump on my left arm 2 days later.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Retinogram normal, Vision blurred
Clinical narrative: Within 30 min after, felt a hollow ear on my left side, but that only lasted a few minutes. The next morning, it felt like something hit my left eyeball or something popped in my left eyeball, then immediately saw a grey film over my left eye that lasted about 30 min then slowly went away. My left arm vase very painful, radiating up my neck to my jaw and temple. I proceeded to get a migraine type headache. There is a large swollen, red lump on my left arm 2 days later.
Age: 77.0
Sex: F
Vaccine: COVID19, FLUA4, RSV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: redness, swelling, and itching of left arm after first day
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache
Clinical narrative: did not have any symptoms until late Monday 10/23/2023 and by 10/24/2023 it was worst severe headache, joint pain, sleepy/tired, felt extremely cold, shivering.  the entire upper arm was Extremely swollen and red, the area was hard and HOT to touch, and the area was very painful. visited urgent care and was encourages to notify the CDC. and was prescribed antibiotics and Tylenol, Zyrtec and hydrocortisone ointment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: did not have any symptoms until late Monday 10/23/2023 and by 10/24/2023 it was worst severe headache, joint pain, sleepy/tired, felt extremely cold, shivering.  the entire upper arm was Extremely swollen and red, the area was hard and HOT to touch, and the area was very painful. visited urgent care and was encourages to notify the CDC. and was prescribed antibiotics and Tylenol, Zyrtec and hydrocortisone ointment.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: did not have any symptoms until late Monday 10/23/2023 and by 10/24/2023 it was worst severe headache, joint pain, sleepy/tired, felt extremely cold, shivering.  the entire upper arm was Extremely swollen and red, the area was hard and HOT to touch, and the area was very painful. visited urgent care and was encourages to notify the CDC. and was prescribed antibiotics and Tylenol, Zyrtec and hydrocortisone ointment.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Migraine
Clinical narrative: Migraine Headache, Diarrhea
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness below injection site.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Dizziness, Ear discomfort, Fear
Clinical narrative: HEARING LOSS IN LEFT EAR, COMPLETE LOSS PRESSURE IN LEFT EAR I recieved the vaccine on 1/23/2023 at 1130am.  On 1/25/2023 woke up with complete hearing loss in left ear.   I was very dizzy all day and had to lay down .  I went to medical doctor on 1/25/2023 at 240pm  and saw a primary care provider who said it could be from covid vaccine.  I had a hearing test that I failed.  She examined my ears and it looked completely normal.  She perscribed prednizone 20mg for 5 days and said to follow up with ENT.  I have a ENT appt for tomorrow 1/27/2023 at 730am for a hearing test and to see a medical provider.   I woke up today on 1/26/2023 my hearing is still gone with still pressure in ear.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide increased
Clinical narrative: 03/03/2021 NT-PRO BNP Result 36 pg/ML 11/30/2021 COVID VACCINE 03/14/2022 NT-PRO BNP Result 80 pg/ML 10/09/2023 NT-PRO BNO Result 236 pg/ML
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Intraocular pressure increased, Vision blurred
Clinical narrative: blurry vision and i ncreased eye pressure after the covid and flu shot vaccines.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated that her arm was swollen down to her elbow, but not around her arm. Her shoulder and arm has been hurting, so she went to doctor. Doctor told her she has bursitis.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: patient has severe arm pain cant lift arm
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Epistaxis, Fatigue, Feeling abnormal
Clinical narrative: He got his vaccine (reported by wife), he told his wife that he was getting dizzy.  Then he started throwing up, but was throwing up blood.  Then he had aches and was feeling bad.  He woke up in the middle of the night with bleeding in the nose and had that for 2-3 days.  He refused to go to the ER in the middle of the night, but he went to the ER the next day.  He was put on allergy relief medicine every 4 hours and also was put on Dexamethasone Sol, Levofloxacin 750 antibiotics.  Since he received the medicine that he got yesterday, but did not want to get the medicine.  She has seen since then that he has improved a little bit, but is tired, does not have the energy that he used to have.  He told his wife that when he went to work he would sleep in the car as he could not manage to work.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Sleep disorder, Vomiting
Clinical narrative: He got his vaccine (reported by wife), he told his wife that he was getting dizzy.  Then he started throwing up, but was throwing up blood.  Then he had aches and was feeling bad.  He woke up in the middle of the night with bleeding in the nose and had that for 2-3 days.  He refused to go to the ER in the middle of the night, but he went to the ER the next day.  He was put on allergy relief medicine every 4 hours and also was put on Dexamethasone Sol, Levofloxacin 750 antibiotics.  Since he received the medicine that he got yesterday, but did not want to get the medicine.  She has seen since then that he has improved a little bit, but is tired, does not have the energy that he used to have.  He told his wife that when he went to work he would sleep in the car as he could not manage to work.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 0.5ml withdrawn from SINGLE DOSE VIAL and administered.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Lump at the injection site, Initially the size of a golf ball with redness and itching .  Swelling has decreased as well as the itching.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Patient appears to have a brief seizure just after vaccine administration. Pt stabilized quickly with no apparent injury. Patient declined RPh suggestion to call EMS. Patient agreed to call primary MD after leaving pharmacy. Pt left in stable condition.
Age: 57.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Dizziness, Mobility decreased, Muscular weakness, Pain
Clinical narrative: severe pain, decreased range of motion, muscle weakness, temporarily dizziness and lightheadedness, chills
Age: 10.0
Sex: M
Vaccine: COVID19, FLU4, HEPA, IPV
Symptoms: Pyrexia
Clinical narrative: Father stated child only had fever for one day and is doing fine now
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain, Sensory disturbance
Clinical narrative: Once covid vaccine was administered, patient stated she could taste the vaccine as the pharmacist was giving the shot. Once the shot was completed, patient had a pulsating feeling all throughout her chest that traveled down her body and into her lower body. Patient stated that she had a pain all over and after about 15-20 minutes this feeling went away. We checked the patient's blood pressure to make sure she would be okay before leaving and her blood pressure was elevated with readings of 168/90, 168/93, and 175/95. The patient felt okay to drive home after the pain subsided. We will follow up with the patient to make sure her blood pressure goes back to normal and to check in and make sure she doesn't have any further reactions.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Thirst
Clinical narrative: 0.5ml withdrawn from a SINGLE DOSE VIAL and administered. Patient vomited @ 3pm on the bus on the way home from school this day.  Woke at 2am thirsty and feeling warm. Temporal T 100 at this time. Woke this morning feeling much better temporal T 99.0
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Dyspnoea
Clinical narrative: Patient was fine for almost 48 hours after the vaccination. Then she started having shortness of breath and lots of coughing. Patient has been trying to get this under control since then and is still dealing with this now. To me it sounds like a COPD exacerbation somehow brought on by the vaccination. She has been having to use Duoneb nebulizer solution every 6 hours around the clock and her rescue albuterol inhaler every 4 to 6 hours since this started.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after viability date.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine given on 10/24/23, expiration date of 10/08/2023
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cognitive disorder, Diaphragmatic spasm, Fatigue, Muscle tightness
Clinical narrative: Cognitive distortion, loss of balance, muscle tension, muscle tremors, fever, chest diaphragm spasms and fatigue... Face swelling.  This lasted for a few hours, when I woke up at 10am, I still had tremors, but no other symptoms.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Tremor
Clinical narrative: Cognitive distortion, loss of balance, muscle tension, muscle tremors, fever, chest diaphragm spasms and fatigue... Face swelling.  This lasted for a few hours, when I woke up at 10am, I still had tremors, but no other symptoms.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Cellulitis
Clinical narrative: Patient advised to seek treatment for diagnosis and medical treatment. Diagnosed with cellulitis and treated with Keflex
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after viability date.
Age: 33.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Chest discomfort, Injection site bruising, Injection site erythema, Injection site induration, Rash macular
Clinical narrative: Reports red blotchy, bruised and hardness at the site of Varivax throughout her arm. Following with chest tightness and urticaria throughout body for 1.5 week.
Age: 33.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Reports red blotchy, bruised and hardness at the site of Varivax throughout her arm. Following with chest tightness and urticaria throughout body for 1.5 week.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Clavicle fracture, Computerised tomogram head abnormal, Condition aggravated, Electrocardiogram abnormal
Clinical narrative: Within two hours of taking it, I had a convulsion then eight partial seizures. This did not stop it just escalated, I have now gone from having three convulsions over 29 years of my entire life to suffering well over 200 convulsions within the last three years. Finding myself waking up face down in puddles of my own blood, wetting myself, loosing my memory entirely forexample forgetting who my own parents are and forgetting who people are whom I have met at least three times.  I have lost any ability to work, live independently, date, or live any kind of a normal life as I watch most of my friends in my thirties have children and buy their own homes I am now left permanently physically disabled and my mental health has deteriorated massively becuase of it all.  I honestly think most people would have hung themselves already if they found themselves in my position.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Impaired work ability, Loss of personal independence in daily activities, Magnetic resonance imaging head abnormal, Memory impairment
Clinical narrative: Within two hours of taking it, I had a convulsion then eight partial seizures. This did not stop it just escalated, I have now gone from having three convulsions over 29 years of my entire life to suffering well over 200 convulsions within the last three years. Finding myself waking up face down in puddles of my own blood, wetting myself, loosing my memory entirely forexample forgetting who my own parents are and forgetting who people are whom I have met at least three times.  I have lost any ability to work, live independently, date, or live any kind of a normal life as I watch most of my friends in my thirties have children and buy their own homes I am now left permanently physically disabled and my mental health has deteriorated massively becuase of it all.  I honestly think most people would have hung themselves already if they found themselves in my position.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Partial seizures, Physical disability, Seizure, Temporal lobe epilepsy
Clinical narrative: Within two hours of taking it, I had a convulsion then eight partial seizures. This did not stop it just escalated, I have now gone from having three convulsions over 29 years of my entire life to suffering well over 200 convulsions within the last three years. Finding myself waking up face down in puddles of my own blood, wetting myself, loosing my memory entirely forexample forgetting who my own parents are and forgetting who people are whom I have met at least three times.  I have lost any ability to work, live independently, date, or live any kind of a normal life as I watch most of my friends in my thirties have children and buy their own homes I am now left permanently physically disabled and my mental health has deteriorated massively becuase of it all.  I honestly think most people would have hung themselves already if they found themselves in my position.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Within two hours of taking it, I had a convulsion then eight partial seizures. This did not stop it just escalated, I have now gone from having three convulsions over 29 years of my entire life to suffering well over 200 convulsions within the last three years. Finding myself waking up face down in puddles of my own blood, wetting myself, loosing my memory entirely forexample forgetting who my own parents are and forgetting who people are whom I have met at least three times.  I have lost any ability to work, live independently, date, or live any kind of a normal life as I watch most of my friends in my thirties have children and buy their own homes I am now left permanently physically disabled and my mental health has deteriorated massively becuase of it all.  I honestly think most people would have hung themselves already if they found themselves in my position.
Age: 61.0
Sex: F
Vaccine: FLU4, PNC20, RSV
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: patient states after 3 weeks she still experiencing fatigue, swallon lymph nodes.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Mobility decreased, Tenderness, X-ray
Clinical narrative: Extended tenderness x 30 days, limited mobility
Age: 70.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Headache
Clinical narrative: She got her vaccines, she could not figure out what happened.  She had a sore arm and then had the headache that she took 2 Advil and the pain went away.  It was okay, had a headache, took some Advil and then continued on and off for a few days and then realized that it was from the vaccine.  She continued to the Advil and the third day it went away and she stopped taking the Advil.  She did not have any other symptoms.  She does not normally have headaches.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypertension
Clinical narrative: High Blood Pressure
Age: 64.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. Patient had already received a fluarix vaccination on  9/21/23.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: 0 treat,emt or outcome.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Was preparing vaccines for this child and accidently gave him the 12+ Moderna vaccine instead of the 6m-11y. No adverse reactions, Parent's were notified, MD notified. Child is fine.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Immunisation reaction, Vomiting
Clinical narrative: It was reported to clinic staff that the patient started vomiting shortly after receiving the COVID vaccine. She was taken to the hospital. It was reported to us that she was diagnosed with vomiting and hypertension secondary to a vaccine reaction.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Was preparing vaccines for this child and accidently gave her the 12+ Moderna vaccine instead of the 6m-11y. No adverse reactions, Parent's were notified, MD notified. Child is fine.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient passed out while checking out and hit head.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Injection site erythema, Lethargy
Clinical narrative: Vaccine is identified as Comirnaty by Pfizer. I had redness at the site, larger than normally seen with other shots.  At midnight bedtime, I was totally wiped out; lethargic, lightheaded, and felt like I would faint. This was felt from 12:00 a.m. on 10/24 through the entire day.  (I did have syncope with the 2nd dose of Moderna Covid vaccine ion 1/30/2021, and fell on my face, heavy bruising and black eye; had a brain scan but no enduring issues.) So I was cautious this time drinking during the night with bottled water by bedside, and woke my husband if I had to go to the bathroom so I would not faint again; otherwise, I believe I would have. I began feeling myself on day 10/25 a.m.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient's parent's schedule patient to receive an annual influenza vaccine along with sibling. At the visit Patients name and DOB were checked but verification of actually being 6 months was not. Patient received flu vaccine 14 days before being eligible at 6 months. This incident was not found out until patient came back for second flu vaccine. Patient had no adverse reaction or issues with the injection. Office spoke with GSK pharmacist who had no studies or documentation on patient receiving flu vaccine before age of 6 months.  Patient was 5 months and 16 days or 24 weeks and 1 days.  Writer also spoke with CDC to discuss information.  CDC states generally believes that this would not be harmful to patient. Often these doses should be ignored.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Product use issue
Clinical narrative: Child sent by school staff for Flu vaccine by health department.  After the school flu drive, it was found that the patient in question did not have parental consent on file at the school.   The child had no clinical adverse reactions or outcomes from vaccine.  No further treatment or follow up visits necessary for the child.  Parents were notified by the school and contacted by the health department.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: None stated.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Conjunctival haemorrhage
Clinical narrative: Subconjunctival hemorrhage right eye  onset 10/13 / 23 and becoming severe  11/14~15 I have had prior similar events probably due to blood thinner and an familiar with the condition. This event however was unique in its severity?if the prior worst events were rated a 6, this event would be rated a 10
Age: 69.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 doses of RSV vaccine (Arexvy) on 08/19/2023 and 10/16/2023.  Patient has not experience any side effects/adverse events.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, pain, swelling, and itching
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bursitis, Insomnia, Loss of personal independence in daily activities, Neck pain
Clinical narrative: Severe arm, neck and shoulder pain within 5 hours of injection. Pain unbearable for first two dayUnrelieved by ibuprofen, acetaminophen, ice or heat and continuing through day 12 after injection. Diagnosed with bursitis on 10/25/2023. Unable to sleep, lift anything with right arm, or swim which is the patient's primary form of exercise.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe arm, neck and shoulder pain within 5 hours of injection. Pain unbearable for first two dayUnrelieved by ibuprofen, acetaminophen, ice or heat and continuing through day 12 after injection. Diagnosed with bursitis on 10/25/2023. Unable to sleep, lift anything with right arm, or swim which is the patient's primary form of exercise.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the wrong vaccine for his age.  Patient was administered the Fluzone High Dose that is not approved for under the age of 65.