chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left arm pain and swelling.   Advised this is a common reaction up to 4 days after the vaccine but redness is worse at day 6 but the swelling possible local reaction or hematoma has not changed in size.  No fever, secondary wounds, or severe illness. Starting on a oral antibiotic to cover for acute cellulitis, warm compress, compression sleeve and if no improvement will need to get imaging and labs next week.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Paraesthesia, Paralysis
Clinical narrative: Paralysis, tingling, extreme fatigue
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Sleep disorder
Clinical narrative: Random small pumps; itchy;  I scatched them before realizing or looking for any fluids in them.  Notice them on stomach , chest, upper thighs;  just ramdom.  Last night I felt like I had a rash on my wrist.  The itching kept me up most of the night.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given fluad flu vaccine and she is 61 and was suppose to receive the fluarix flu vaccine.  Patient had no adverse reaction. Patient was fine. Wrong type of flu vaccine was given.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Head discomfort, Lethargy, Paraesthesia, Pharyngeal swelling
Clinical narrative: Patient reported to immunizer after receiving vaccine, that he was feeling lethargic. Patient stated feeling heaviness in his face and back of his head. He stated that he was having tingling sensation in his extremities and felt his throat was swelling. Pharmacist immediately administered epinephrine 0.3mg auto injector into patient's left thigh and continued observing the patient. Patient reported beginning to feel like he can breath easier but still feeling lethargic. Pharmacist proceeded to call 911 and while on the phone with 911 agent, patient stated he was feeling better but the call to 911 should be cancelled. Patient sat at the waiting area for about 15 minutes and later got up and said he wanted to leave and left with his mother by his side
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Fatigue, Tachycardia
Clinical narrative: Tachycardia - felt pulse rate quicken and upon checking pulse oximeter it was well above 115 beats per minute. Noticed pain on right side of heart and sudden tiredness
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Electrocardiogram, Full blood count, Metabolic function test, Throat tightness
Clinical narrative: 10 minutes felt throat closing/ trouble swallowing. Went to ED had steroids and benadryl and epi-Pen in ED
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Troponin, Urine analysis, X-ray
Clinical narrative: 10 minutes felt throat closing/ trouble swallowing. Went to ED had steroids and benadryl and epi-Pen in ED
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: I experienced fever, headache and nausea; I experienced fever, headache and nausea; I experienced fever, headache and nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28Sep2024 at 11:30 as dose 1, single (Lot number: LM2216) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; LEVOTHYROXINE. The following information was reported: PYREXIA (non-serious), HEADACHE (non-serious), NAUSEA (non-serious) all with onset 28Sep2024 at 23:00, outcome "recovered" (29Sep2024) and all described as "I experienced fever, headache and nausea". Therapeutic measures were not taken as a result of pyrexia, headache, nausea.  Additional information: It was reported that the patient taking other medications within 2 weeks of the event starting (unspecified drug). The patient also reported a co-suspect drug (unspecified product, Manufacturer: Sanofi-Pasteur) with lot number UT8488KA on 28Sep2024 at first dose, left arm.  Approximately 12 hours after injection, patient experienced fever, headache and nausea.  No follow-up attempts are possible.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Patient feels hot, sweaty, dizzy
Age: 23.0
Sex: F
Vaccine: FLUA3, MMR
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccine. Patient will need additional dose 28 days from administration.
Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Dizziness, Dry mouth, Fatigue, Injection site pain
Clinical narrative: Dizziness, fatigue, chills, dry mouth, soreness of arm where he received vaccine
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The diluent that the vaccine was mixed with expired yesterday.
Age: 1.42
Sex: F
Vaccine: COVID19, DTAP, FLU3, HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received her COVID vaccination undiluted
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Administered a second RSV dose when patient had already received RXV vaccine last October (2023). The state vaccine registry was accessed and reviewed, however, it is not sorted by date and I missed the RSV vaccine listed towards the bottom which was given Oct 2023.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was reconstituted with a diluent that expired yesterday.
Age: 81.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Back pain, Flatulence, Moaning, Pain in extremity, Vomiting
Clinical narrative: Less than five minutes after vaccination-moaning because of pain in lower back and legs, passed gas and felt some relief, threw up and felt some relief. EMS arrived and took pt to ER.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, PNC20, YF
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Blood creatinine increased, Computerised tomogram head normal, Full blood count normal
Clinical narrative: The patient developed the following symptoms on 7/2/24: "a very tiny, specific pulling sensation on the left lower lip.  It feels like a small thread is pulling when i eat, or move my lip a certain way."  She then developed left hand tingling on 7/3/24 and had a full work up which was negative (see below).  By 7/5/24 the lip sensation was still present but was lessening.  All symptoms resolved by 7/7/24.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, PNC20, YF
Symptoms: Glomerular filtration rate decreased, International normalised ratio normal, Magnetic resonance imaging head normal, Metabolic function test normal, Oral discomfort
Clinical narrative: The patient developed the following symptoms on 7/2/24: "a very tiny, specific pulling sensation on the left lower lip.  It feels like a small thread is pulling when i eat, or move my lip a certain way."  She then developed left hand tingling on 7/3/24 and had a full work up which was negative (see below).  By 7/5/24 the lip sensation was still present but was lessening.  All symptoms resolved by 7/7/24.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, PNC20, YF
Symptoms: Paraesthesia, Vertebral artery stenosis, Vertebral artery thrombosis
Clinical narrative: The patient developed the following symptoms on 7/2/24: "a very tiny, specific pulling sensation on the left lower lip.  It feels like a small thread is pulling when i eat, or move my lip a certain way."  She then developed left hand tingling on 7/3/24 and had a full work up which was negative (see below).  By 7/5/24 the lip sensation was still present but was lessening.  All symptoms resolved by 7/7/24.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Vomiting, Weight decreased
Clinical narrative: Patient called approximately 24 hours after vaccination and stated she had lost 4 pounds over night with constant vomiting and diarrhea. She was only able to hold down small amounts of water/coffee.
Sex: F
Vaccine: FLU3
Symptoms: Deafness, Headache, Vision blurred, Vomiting
Clinical narrative: Patient reported that after 5 to 10 minutes after the vaccination having, blurry vision  and  loss of hearing for a few minutes , vomiting , pain in head and headache. Came back to me at about 11: 40am and disclosed that she is having a mild headache.  Pharmacist recommended to go seek medical attention right away ( ER or Urgent care) to check and evaluate  her further.  Vaccine given
Age: 1.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: adult hep B vaccine given to infant no adverse outcomes no additional treatment suggested
Age: 3.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Febrile convulsion
Clinical narrative: ? febrile seizure patient seen in the ER following event
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Dizziness lasting approximately 6 hours. Would not abate or improve on its own. Resolved only after taking 50 mg meclizine. The dizziness occurred after a period of mild fever and chills. After fever and chills abated the dizziness started. The dizziness was not experienced after any previous COVID-19 mRNA vaccine or booster.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: On September 23rd, the computer system was down from 3-4 pm so couldn't look up the patient, filling, verifying any medications.  The pharmacy was still taking in patients for appointments and would bill thru their insurance later on once the system was back on. I gave to a patient that had an appointment his flu vaccine and covid vaccine, but when the system was back on the next day and tried to bill through  his insurance we realized he had received his flu shot last month and he may not have realized that he did. I was notified because I was off and couldn't make a report until Friday.  He didn't experience any side effects from the vaccine at the time of administration and didn't call back regarding on how he has been doing.  I did report to my manager on Friday, September 27th and got my report # and had informed to make this report.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received High Dose Fluzone vaccine and is only 63 years of age.   Patient notified and reported no adverse reaction.  Reporting this event as a medication error.
Age: 88.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Gait disturbance, Gait inability, Muscular weakness, Walking aid user
Clinical narrative: Morning after vaccines, pt. complains that should couldn't walk, her legs felt like rubber, she had to use a cane for 5 days, she was not steady on her knees and hips and felt like she had duck feet (feet wanting to be outward).
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Itchy Rash that started/around the injection site and went up the neck.  Patient was provided oral benadryl 25mg po and slowly relieved the symptoms.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Dizziness, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient got covid vaccine first then flu shot. She fainted after receiving the flu shot. She passed out for about 4  minutes. When she woke up she was still feeling dizzy and looks pale. She drank water/gatorade. 911 came. Paramedics took her
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Micturition disorder, Tremor
Clinical narrative: Knocked OUT; flu; Shaking; Fast Urination; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MICTURITION DISORDER (non-serious) with onset 2024, outcome "unknown", described as "Fast Urination"; FATIGUE (non-serious) with onset 2024, outcome "unknown", described as "Knocked OUT"; TREMOR (non-serious) with onset 2024, outcome "unknown", described as "Shaking"; INFLUENZA (non-serious) with onset 2024, outcome "unknown", described as "flu".  Additional information: The reporter informed that her aunt who received COVID-19 vaccine got very sick (flu, shaking, fast urination, knocked out).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: soreness+redness at injection site. treatment = cold compress and ibuprofen for inflammation
Sex: U
Vaccine: COVID19
Symptoms: Cardiac operation
Clinical narrative: heart surgery; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC OPERATION (hospitalization), outcome "unknown", described as "heart surgery". Therapeutic measures were taken as a result of cardiac operation. The patient had a very, very bad experience with the Pfizer Covid 19. The patient just found out that the experience that the patient had was something that others have had but particularly in the states of (withheld) and (withheld). The patient spent a lot of time in the hospital because of it. The patient had heart surgery.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Anaphylactic reaction
Clinical narrative: had an anaphylactic reaction; This is a spontaneous report received from a Pharmacist, Program ID.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "had an anaphylactic reaction".  Clinical course: The pharmacist asking what are the inactive ingredients in Prevnar 20. He mentioned that he had a patient who had an anaphylactic reaction before and he wanted to make sure.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of ANAPHYLACTIC REACTION might not be fully ruled out, considering the temporal relationship and known adverse event profile of the suspect vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had 3 shots and still get Covid; I had 3 shots and still get Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had 3 shots and still get Covid".  Clinical course: The patient doesn't feel confident in the vaccines. She had 3 shots and still get Covid.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: accidentally administering vaccine to pediatric patient, with no reported adverse event; Initial information received on 17-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9-year-old male patient who accidentally got administered influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] vaccine to pediatric 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 HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) for prophylactic vaccination (immunization).  On 20-Aug-2024, the patient received 0.5 ml dose of suspect influenza USP trival A-B high dose subvirion vaccine (Strength- High Dose) (Frequency- once) Suspension for injection (lot- UT8415JA and expiration date- 30-JUN-2025) via intramuscular route in the right deltoid for Influenza and accidentally administering vaccine to pediatric patient, with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  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.; Sender's Comments:  US-SA-2024SA282305:
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Adacel administered post temperature excursion with no reported Adverse event; Initial information received on 17-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered post temperature excursion with no reported 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 an unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection of lot U7905AA and expiry date: 03-Oct-2025 via unknown route in unknown administration site for Immunization post temperature excursion with no reported adverse event (poor quality product administered) (latency: on same day).  Reportedly, Max/low temperature reached: 32F to 49F for Total of 4 hours. Human error was Unknown, extended stability data does not cover the excursion for unopened ADACEL and punctured IPOL.   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: 12.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Intentional underdose, No adverse event
Clinical narrative: A 12-year-old patient presented in our clinic to receive their updated COVID-19 Moderna vaccine booster and annual influenza vaccine with their family. One of our Medical Assistants administered a lower than recommended dose level, only for the Moderna COVID-19 vaccine, to this patient. Instead of administering the recommended Moderna 12+ (0.5mL) COVID-19 vaccine, the patient received the lower than recommended Moderna 6mo-11yr (0.25mL) COVID-19 vaccine dose. The patient did not experience any immediate or adverse reactions to receiving the lower than recommended dose of the COVID-19 vaccine before leaving our clinic.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chills, Incontinence, Malaise, Tremor
Clinical narrative: At 6pm, 7 hours post injection, chills with full body tremors began and lasted for 4 hours. Upon waking at 8:30 am the next day, 21.5 hours post injection, incontinence began which lasted for 12 hours. General malaise continued until 96 hours post injection.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: vasovagal syncope happened x 2
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose was administered to 60 years old.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient presented for a Covid-19 24-25 vaccination. The vaccine was not diluted. Patient was given .1ml of undiluted vaccine. No known signs or symptoms related to incorrect dosing.
Age: 43.0
Sex: M
Vaccine: FLU3, HEPA, JEV1, RAB, TDAP, TYP
Symptoms: Amnesia, Feeling abnormal, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient stated he felt wacky after 5 the vaccine was administered and blacked out.  Patient was so pale and not aware what happened.  He was sweating a lot.  Provided cold compress and water.
Age: 72.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chest discomfort, Electrocardiogram ambulatory, Extrasystoles, Myocardial necrosis marker normal, Palpitations
Clinical narrative: left upper sternal chest discomfort (not angina), palpitation, ectopic beats with trigemini at the onset
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Mistakenly gave a flu shot instead of Covid
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Patient experiencing chills, body aches and fatigue
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given flu vaccine prior to 6 months of age. No adverse reaction noted at this time but vaccine was administered outside of acceptable age range.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Urticaria
Clinical narrative: Patient received Dtap, Polio, and Hepatitis A vaccine around 3:10 PM. Five minutes after giving the vaccine it was noted hives started to appear on her cheeks and arms. Observed patient after 10 minutes hives did start to go down. Around 3:25pm MD was informed of hives. At 3:35 pm 15mg (6ml) of Diphenhydramine was given.   At 3:50PM hives where almost gone. By 4 PM patient caregiver was ready to go as hives had completely gone.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Patient presented back to the immunization clinic, complaining of pain and swelling
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This patient had requested a flu shot and was given the Moderna Covid vaccine. There were no adverse events reported at the time of vaccination or immediately after.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Noted redness/rash at injection site for MMR and Varicella immediately after administration. Both sites warm to touch. No audible wheezing, no respiratory discomfort, lung sounds auscultated without wheeze. Denies itching at injection site. Monitored for over 15 minutes after vaccinations for any changes, sites seemed to improve over time. Placed ice packs on sites for brief time, sent packs home with parent. Mom reports will provide child with Benadryl later just in case. Recommended to contact this RN if notices that sites seem to be getting worse and not improving.
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Body aches, chills, fevers. When woke up she felt very weak and dizzy w/vomiting. Those sx resolved, but dizziness continued as of today 10/2/24
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vomiting
Clinical narrative: Body aches, chills, fevers. When woke up she felt very weak and dizzy w/vomiting. Those sx resolved, but dizziness continued as of today 10/2/24
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Hypoaesthesia, Hypoaesthesia oral, Skin discomfort
Clinical narrative: Numbing of lips, cheeks, and then difficulty breathing, chest pain and felt like blotching of skin on chest was starting but did not develop due to medications administered for allergic reaction.                                                                                                                                                            dexAMETHasone sodium phosphate injection 10 milligram(s) IV Push Given 17:48 10/2/2024 diphenhydrAMINE injection  25 milligram(s) IV Push Given 16:44 10/2/2024 famotidine intravenous  20 milligram(s) IV Push Given 16:43 10/2/2024 sodium chloride 0.9 % intravenous  1000 milliliter IV Fluid Bolus Given 16:43 10/2/2024 EPINEPHrine injection  0.300 milligram(s) Subcutaneous Given 16:34 10/2/2024                                                                                                             .Patient admitted to ED at 4:33pm, symptoms improved, and discharged to home at  6:49pm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Pt could not confirm how many shots she had of shingles. Checked the state registry and it said she was due for shot. Had a disscussion with pt to see if she wanted it. We ended up giving the vaccine.
Age: 81.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: PATIENT STATES THAT SHE WOKE UP WITH A RED, ITCHY RASH COVERING 75% OF HER BODY 3 DAYS AFTER THE VACCINE WAS GIVEN. SHE STATES THAT THE RASH WAS PREDOMINANT AROUND THE SITE OF INJECTION BUT SPREAD ALL OVER HER UPPER BODY AND DOWN TO HER KNEES.  SHE REPORTED THIS RASH TO US ON 10/2/2024 AFTER RECEIVING A PRESCRIPTION FOR TRIAMCINOLONE AND HYDROXYZINE TO TREAT THE ITCHING AND RASH (ALSO ON 10/2/24). AT THIS TIME, SHE STILL HAS THE RASH (RASH SYMPTOMS FROM 9/21/24 TO PRESENT)
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient had received Fluad instead of Flucelvax
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: 6mo-4yr multidose vial (3 doses) not diluted and patient given the full contents IM. No symptoms yet, 2 hrs after administration
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate vaccination. he received a Flucelvax flu vaccine on 07/24/204 and then again on 10/01/2024
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Incoherent, Pyrexia
Clinical narrative: Speaking incoherently, fever 101.6 to 102 F lasting a couple of hours, high blood pressure
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Migraine, Pain in extremity
Clinical narrative: Headache, migraine, arm soreness, fatigue, exhaustion, flu-like symptoms
Age: 62.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood pressure increased, Dizziness, Paraesthesia oral, Tension headache
Clinical narrative: PATIENT FELT DIZZY AND HAD A TENSION TYPE HEADACHE. SHE ALSO EXPERIENCED TINGLING ON HER LIPS AND HER BLOOD PRESSURE WAS HIGHLY ELEVATED.
Age: 30.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash under both arms in armpit
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Patient claimed to have difficulty breathing approximately 10 seconds after vaccine was given.  Patient was given 10mg of loratadine and escorted to a chair in the waiting area.  At no time did the patient show any signs of respiratory distress. Patient was on phone with speaker mode on and pharmacy technician overheard other party say that the vaccine was poison and they are trying to kill us. At this point the patient asked the technician to call EMS.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Acoustic stimulation tests abnormal, Ear discomfort, Hyperacusis, Hypoacusis, Injection site pain
Clinical narrative: Sudden change in hearing the day following vaccination (Hyperacusis, feeling of fullness in the ears, change in the perception of sound, annoying sound in my ears with each footstep while walking). The left arm was sore (site of Shingrix) but not the right arm. I contacted my audiologist and was directed to contact my immunologist. My immunologist put in a stat order for an appointment with otolaryngology. I then had a hearing test with audiology on Friday, September 13, 2024, which indicated a 15 decibel loss at one frequency. I saw a physician's assistant in otolaryngology on the following Monday, September 16, 2024. No treatment was prescribed. My symptoms continue without resolution.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Tinnitus
Clinical narrative: Sudden change in hearing the day following vaccination (Hyperacusis, feeling of fullness in the ears, change in the perception of sound, annoying sound in my ears with each footstep while walking). The left arm was sore (site of Shingrix) but not the right arm. I contacted my audiologist and was directed to contact my immunologist. My immunologist put in a stat order for an appointment with otolaryngology. I then had a hearing test with audiology on Friday, September 13, 2024, which indicated a 15 decibel loss at one frequency. I saw a physician's assistant in otolaryngology on the following Monday, September 16, 2024. No treatment was prescribed. My symptoms continue without resolution.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Fibrin D dimer increased, Pericardial effusion, Pericarditis
Clinical narrative: Pericarditis with pericardial effusion
Age: 69.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Pain in extremity
Clinical narrative: Patient said he has long-last pain on his right arm ever since the vaccines.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Myalgia, Pyrexia, Rhinorrhoea
Clinical narrative: Chills, fever, cough, sneezing, runny nose, muscle aches,
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Chills, fever, cough, sneezing, runny nose, muscle aches,
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Medication error - unnecessary dose: pt has received flu vaccine a week ago but received another flu vaccine by medication error.
Age: 84.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Discoloured vomit, Feeding disorder, Headache, Lethargy
Clinical narrative: Patient states on Saturday morning (2 days after admin of vaccines) woke up with a headache, fever, chills and vomiting. Patient states she vomited approx. 7 times that day and her vomit was "black" and felt lethargic. Patient states she wasn't able to eat until Sunday (just broth), and solid food until Monday.
Age: 84.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient states on Saturday morning (2 days after admin of vaccines) woke up with a headache, fever, chills and vomiting. Patient states she vomited approx. 7 times that day and her vomit was "black" and felt lethargic. Patient states she wasn't able to eat until Sunday (just broth), and solid food until Monday.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Cough, Diarrhoea, Fatigue, Malaise
Clinical narrative: Day of vaccine: Diarrhea,, cough. Next day: Severe malaise, fatigue, brain fog.
Age: 31.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: Left arm experienced continued muscle soreness since immunization and continues to this day. Difficulty changing clothes and doing hair.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased
Clinical narrative: Shortly after receiving the vaccine it became harder and harder to lift my left arm higher than my shoulder. I felt a throbbing pain in the injection site for much of that night. I could not move my left arm above shoulder height the following three days. I saw a physical therapist on the Wednesday following the vaccination the previous Sunday which helped. By Friday, I could lift my arm higher and had more overall mobility back.
Age: 23.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood magnesium normal, Differential white blood cell count normal, Dizziness, Fine motor skill dysfunction, Full blood count normal
Clinical narrative: 09/30/2024: I received the COVID-19 shot in my left arm and the flu vaccine in my right arm at the pharmacy.  10/01/2024: In the evening, I noticed that my arms and hands were slightly numb. I could still feel sensation, but it was decreased. A bit of a tingling sensation, but not painful, or pins and needles. I feel weaker in my hands and like I have a harder time with fine motor skills like texting, but it is not enough to significantly impair my functionality. I also feel a bit lightheaded at times. I have never had a reaction like this to flu or COVID vaccine in the past.   10/02/2024: My symptoms are the same as yesterday throughout the day. During lunch, I picked up a plate with my left hand and immediately dropped it, which is unusual for me.   I was able to get an immediate telehealth consult with my PCP. Based on his assessment, he did not believe immediate action was necessary, but I should continue to monitor my symptoms and come back in two days. He also recommended that I take aspirin for the two days after meals in order to help reduce inflammation and the possibility of blood clots due to the birth control pill I am on.   After work, I went to the emergency room. They took blood tests and did a neurological assessment. Nothing was abnormal, so they gave me an IV to rehydrate me and discharged me to go home.
Age: 23.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Hypoaesthesia, Metabolic function test, Muscular weakness, Paraesthesia
Clinical narrative: 09/30/2024: I received the COVID-19 shot in my left arm and the flu vaccine in my right arm at the pharmacy.  10/01/2024: In the evening, I noticed that my arms and hands were slightly numb. I could still feel sensation, but it was decreased. A bit of a tingling sensation, but not painful, or pins and needles. I feel weaker in my hands and like I have a harder time with fine motor skills like texting, but it is not enough to significantly impair my functionality. I also feel a bit lightheaded at times. I have never had a reaction like this to flu or COVID vaccine in the past.   10/02/2024: My symptoms are the same as yesterday throughout the day. During lunch, I picked up a plate with my left hand and immediately dropped it, which is unusual for me.   I was able to get an immediate telehealth consult with my PCP. Based on his assessment, he did not believe immediate action was necessary, but I should continue to monitor my symptoms and come back in two days. He also recommended that I take aspirin for the two days after meals in order to help reduce inflammation and the possibility of blood clots due to the birth control pill I am on.   After work, I went to the emergency room. They took blood tests and did a neurological assessment. Nothing was abnormal, so they gave me an IV to rehydrate me and discharged me to go home.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: fever headache malaise anorexia prostrations   SOB   tightness in chest lost energy for 12 days                                                   Given Decadron 8 my QD for 4 days then Zpak with Tylenol eS 2 Q 4hs PRN
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia
Clinical narrative: fever headache malaise anorexia prostrations   SOB   tightness in chest lost energy for 12 days                                                   Given Decadron 8 my QD for 4 days then Zpak with Tylenol eS 2 Q 4hs PRN
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Arteriogram coronary normal, Blood potassium normal, Chest X-ray normal, Chest pain, Chills
Clinical narrative: Onset of chills, fatigue, vomiting, chest pain about 7 hours after vaccination. Was seen in ED approx 12 hours after vaccination.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Electrocardiogram normal, Fatigue, Neutrophil count decreased, Vomiting, White blood cell count increased
Clinical narrative: Onset of chills, fatigue, vomiting, chest pain about 7 hours after vaccination. Was seen in ED approx 12 hours after vaccination.
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Vision blurred
Clinical narrative: PATIENT CAME TO THE PHARMACY THE NEXT DAY COMPLAINING OF BLURRY VISION AND STATED THAT SHE GOT BLURRED VISION COUPLE HOURS AFTER THE COVID VACCINE. SHE STATED THAT SHE HAS PAST MEDICAL HISTORY OF BLURRY VISION BUT WAS WORRIED IF THE VACCINE ACTUALLY CAUSED THAT.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pt called 10/2 to report that she was still having pain at injection site. Does not hurt if raised up. Hurts to touch or lay on arm. Area not red or raised. Advised pt to contact provider for evaluation. Also to take Tylenol & apply ice.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had swelling and redness at the vax (Tdap and MCV4) administration site - left upper arm after 12 hrs. C/o pain, pt used vaporub and massaged, swelling decreased from yesterday. No other concern. No fever. No syncopy
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Lacrimation increased, Vertigo
Clinical narrative: had vertigo for 3 days after vaccinated  had bad shortness of breath  heavy tearing of mucous in my eyes
Age: 77.0
Sex: F
Vaccine: FLU3, PNC20, RAB
Symptoms: Blister, Erythema, Injection site warmth, Swelling
Clinical narrative: erythema, swelling, little pain all over her left arm
Age: 77.0
Sex: F
Vaccine: FLU3, PNC20, RAB
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: erythema, swelling, little pain all over her left arm
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Pruritus, Rhinorrhoea, Skin tightness, Speech disorder
Clinical narrative: Patient reported generalized itching 20 minutes post vaccine administration. No immediate rash noted during brief assessment by RN at employer flu vaccine clinic. She was immediately taken down to the occupational health clinic for triage and treatment.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Swelling of eyelid, Tongue disorder
Clinical narrative: Patient reported generalized itching 20 minutes post vaccine administration. No immediate rash noted during brief assessment by RN at employer flu vaccine clinic. She was immediately taken down to the occupational health clinic for triage and treatment.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pruritus
Clinical narrative: Patient reported generalized itching 20 minutes post vaccine administration. No immediate rash noted during brief assessment by RN at employer flu vaccine clinic. She was immediately taken down to the occupational health clinic for triage and treatment.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; HCP called after administering a patient a 3rd GARDASIL 9 vaccine after the series was already completed at age 12. Requested information on efficacy/adverse events, see request case. Previous Dates of administration are: 2/27/2019- First GA; This spontaneous report was received from a medical assistance concerning a 16-year-old female.  The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided.  On 27-FEB-2019, the patient was vaccinated with the first dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Then on 09-SEP-2019, she had the second dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  administered for prophylaxis (strength, and route of administration were not provided)  vaccine after the series was already completed at age 12.  However on 18-SEP-2024, the medical assistant called after administering a patient the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #x022735, expiration date: 12-APR-2026, administered for prophylaxis at 16 years old (extra dose administered). No adverse side effects were reported.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Reactive Arthritis" (unspecified if ongoing); "Bee stings" (unspecified if ongoing); "Coconut" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bupropion, reaction(s): "Allergy: Bupropion". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "chills", "fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400261257 same reporter, patient and product; different dose and event;
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Headache, Influenza like illness, Malaise, Pyrexia
Clinical narrative: bad headache; 101 fever; flu (or Covid) like symptoms; feels lousy; This is a spontaneous report received from a Pharmacist.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 27Sep2024, outcome "unknown", described as "101 fever"; HEADACHE (non-serious) with onset 27Sep2024, outcome "unknown", described as "bad headache"; MALAISE (non-serious) with onset 27Sep2024, outcome "unknown", described as "feels lousy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Sep2024, outcome "unknown", described as "flu (or Covid) like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pyrexia, influenza like illness, malaise. Additional information: Patient have been pretty sick all weekend after getting the Covid and Flu shots on Friday (27Sep2024). Patient have had a bad headache for over two days. Patient had 101 fever at the moment and flu (or Covid) like symptoms for over 48 hours. Patient feels lousy so she'll be taking it easy tomorrow (30Sep2024). Patient tested for Covid a couple hours ago (29Sep2024) and it came back negative, but she will test again tomorrow. Patient haven't taken ibuprofen (ADVIL) because pharmacist advised against it with the Covid shot. Paracetamol (TYLENOL) hasn't really touched anything.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: SARS-CoV-2 test
Clinical narrative: bad headache; 101 fever; flu (or Covid) like symptoms; feels lousy; This is a spontaneous report received from a Pharmacist.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 27Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 27Sep2024, outcome "unknown", described as "101 fever"; HEADACHE (non-serious) with onset 27Sep2024, outcome "unknown", described as "bad headache"; MALAISE (non-serious) with onset 27Sep2024, outcome "unknown", described as "feels lousy"; INFLUENZA LIKE ILLNESS (non-serious) with onset 27Sep2024, outcome "unknown", described as "flu (or Covid) like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pyrexia, influenza like illness, malaise. Additional information: Patient have been pretty sick all weekend after getting the Covid and Flu shots on Friday (27Sep2024). Patient have had a bad headache for over two days. Patient had 101 fever at the moment and flu (or Covid) like symptoms for over 48 hours. Patient feels lousy so she'll be taking it easy tomorrow (30Sep2024). Patient tested for Covid a couple hours ago (29Sep2024) and it came back negative, but she will test again tomorrow. Patient haven't taken ibuprofen (ADVIL) because pharmacist advised against it with the Covid shot. Paracetamol (TYLENOL) hasn't really touched anything.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: gets under the weather; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "gets under the weather". Additional information: Reporter's husband normally gets under the weather with the Pfizer Vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Dizziness, Feeding disorder, Headache, Malaise, Vertigo
Clinical narrative: At 11:30 am on 10/02 I became so dizzy I needed help to the bed. Everything was spinning. I threw up twice,  a horrible headache. Unable to tolerate a small amount of food until 4pm. General feeling of malaise. Heading to bed now...taking motrin for headache.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Vomiting
Clinical narrative: At 11:30 am on 10/02 I became so dizzy I needed help to the bed. Everything was spinning. I threw up twice,  a horrible headache. Unable to tolerate a small amount of food until 4pm. General feeling of malaise. Heading to bed now...taking motrin for headache.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Audiogram, Blood test, Lactose intolerance, Tinnitus
Clinical narrative: Developed lactose intolerance which is on-going; tinnitus -ongoing.