chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient Notified. No reaction stated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Migraine, Pain in extremity, Peripheral swelling
Clinical narrative: not long after the shot on 09/29, her arm swelled up and was sore down to the elbow. Her Blood pressure increased, she had a migraine headache and these lasted until  Friday, 10/4 /24, when they started going away.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival discomfort
Clinical narrative: Upper gum irritation severe enough that affected eating, it feels like a few layers of the gum were torn. Cold and room temperature foods, warm water gargling, and Ibuprofen 400 MG are helping. Still recovering not yet healed.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. no reaction stated
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine given outside of "Best By" date. Patient notified. No reaction stated
Age: 39.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Ear pain
Clinical narrative: Patient received both vaccinations in the left deltoid.   Per patient, she experience intermittent sharp pain in right ear shortly the night after vaccinations.  She is not sure if it's due to the vaccines but she's never experience such side effects before.   Today is day 3 and symptoms are still present.  Referred patient to PCP and to take Tylenol or Ibuprofen for the meantime.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: 6 hrs from  injection I experienced increasing  Naseau and Torso Tremors followed by Vomiting at about 8 hrs. Symptoms quickly subsided from the point of vomiting.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Worsened tinnitus
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cold sweat, Eye movement disorder, Immediate post-injection reaction, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: complained of right sided arm pain at time of injection. shortly after, patient eyes rolled back, arms stiffened and paint fainted. Regained consciousness 10secs. after & was pale & clammy. patient had not eaten much prior and room was warm before injection pt given ice packs & pedialyte monitored for 30 minutes after in office
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor
Clinical narrative: complained of right sided arm pain at time of injection. shortly after, patient eyes rolled back, arms stiffened and paint fainted. Regained consciousness 10secs. after & was pale & clammy. patient had not eaten much prior and room was warm before injection pt given ice packs & pedialyte monitored for 30 minutes after in office
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: No other AE; Medical assistant calling to report a 36 year old patient received only partial third dose of GARDASIL 9 due to a leak; Caller did state the issue was due to a leak with the needle and not the GARDASIL 9; This spontaneous report was received from a medical assistant regarding to a 36-year-old female. The patient's pertinent medical history, current conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 02-OCT-2024, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, for prophylaxis, lot number: X026926 that was verified to be valid with expiration date reported and established as 10-APR-2026 (dose, strength, route of administration, vaccination scheme, and anatomical site of vaccination were not provided). However, the patient received only partial third dose of the vaccine due to a leak (Accidental underdose). The reporter stated some of the "liquid leaked out" and that the issue was due to a leak with the needle and not the vaccine itself (Needle issue). Moreover, the needle (which was not supplied by the Company) leaked and there was no issue with connecting the needle to the syringe or becoming detached; the needle connected to the syringe without an issue.  No symptoms and no adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no other AE ocurred; patient received a dose of VARIVAX after a temperature excursion; This spontaneous report was received from a medical assistant, concerning to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the varicella virus vaccine live (oka/merck) (VARIVAX) suffered a temperature excursion for 1 hour and 30 minutes at 10.2 Fahrenheit.   On 10-SEP-2024, the patient was vaccinated with 1 dose of the implicated varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, route of administration, injection site were not provided; Lot number y003891 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), and the expiration date was reported and confirmed to be 06-FEB-2026). The reporter confirmed that no other adverse event ocurred (No adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2410USA001583: US-009507513-2410USA001624: US-009507513-2410USA001407: US-009507513-2410USA001630: US-009507513-2410USA001312: US-009507513-2410USA001417:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient received a dose of VARIVAX after a temperature excursion; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 09-SEP-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y004555, expiration date: 20-FEB-2026, administered for prophylaxis (strength and route of administration were not provided) that underwent a temperature excursion at 10.2 degrees Fahrenheit for one hour and thirty minutes.  It was noted that no previous temperature excursion was experienced.  No other adverse event was reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2410USA001583: US-009507513-2410USA001407: US-009507513-2410USA001630: US-009507513-2410USA001312: US-009507513-2410USA001417: US-009507513-2410USA001590: US-009507513-2410USA001318: US-009507513-2410USA001454: US-009507513-2410USA001596: US-009507513-2410USA001590:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient received a dose of VARIVAX after a temperature excursion; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 09-SEP-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y004555, expiration date: 20-FEB-2026, administered for prophylaxis (strength and route of administration were not provided) that underwent a temperature excursion at 10.2 degrees Fahrenheit for one hour and thirty minutes.  It was noted that no previous temperature excursion was experienced.  No other adverse event was reported.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2410USA001583: US-009507513-2410USA001407: US-009507513-2410USA001312: US-009507513-2410USA001417: US-009507513-2410USA001590: US-009507513-2410USA001318: US-009507513-2410USA001454: US-009507513-2410USA001596: US-009507513-2410USA001624: US-009507513-2410USA001590:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; patient who was administered expired VAQTA on 9/26/2024 (w/ no TEs); This spontaneous report was received from a consumer on behalf of a patient of unspecified age and gender.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 26-SEP-2024, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #1989614 (expiration date: 23-AUG-2024), 0.5ml/dose, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) without temperature excursions (TE) (Expired product administered). However, no symptoms were reported.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: administered after a temperature excursion; No additional AE/PQC reported.; This spontaneous report was received from a nurse and refers to an 1-year-old male patient.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 2nd dose, lot #X020849, expiration date: 26-DEC-2024, administered intramuscularly on the right thigh for prophylaxis (strength, exact dose and units were not provided) following a temperature excursion. No additional adverse event/PQC was reported.  This is one from several reports received from the same reporter. ; Sender's Comments:  US-009507513-2408USA009052: US-009507513-2410USA001631:
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: administeed after experiencing a temperature excursion; No additional AE/PQC reported; This spontaneous report was received from a nurse and refers to a 15-month-old female patient.  The patient's medical history, concurrent conditions previous drugs reactions or allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 3thrd dose, lot #X022980, expiration date: 18-MAY-2026, administered intramuscularly on the right thigh for prophylaxis (strength, exact dose and units were not provided). No additional adverse event/PQC was reported.  This is one from several reports received from the same reporter.; Sender's Comments:  US-009507513-2408USA009052: US-009507513-2410USA001631:
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: administered a dose of Fluzone NP to a patient who had already received a flu shot at a clinic earlier today with no reported adverse event; Initial information received on 23-Sep-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 9-year-old female patient who was administered a dose of influenza USP trival A-B subvirion no preservative vaccine [Fluzone] and had already received a flu shot at a clinic earlier today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2024, the patient received a 0.5 ml dose of suspect Influenza USP TRIVAL A-B Subvirion No Preservative Vaccine Suspension for injection (frequency: once, strength: standard) of lot U8500AA and expiry date: 30-Jun-2025 via intramuscular route in the left deltoid for Immunization who had already received a flu shot at a clinic earlier today with no adverse event (extra dose administered)(latency: on 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.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Chills, Dizziness, Myalgia, Pyrexia
Clinical narrative: Whole body Muscle aches, Fever, Chills, Joint pain, Dizziness started ~8-10 hours after injection
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Autoimmune disorder, Blood thyroid stimulating hormone, Computerised tomogram head
Clinical narrative: PROPTOSIS OF THE RIGHT EYE, BLURRY VISION, INFLAMMATION IN EYES, EXTREME PAIN IN EYES, DRY EYES, AUTOIMMUNE DISEASE, HYPERTHYROIDISM, EXTREME PAIN IN ARMS AND LEGS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Exophthalmos, Eye inflammation, Eye pain, Hyperthyroidism
Clinical narrative: PROPTOSIS OF THE RIGHT EYE, BLURRY VISION, INFLAMMATION IN EYES, EXTREME PAIN IN EYES, DRY EYES, AUTOIMMUNE DISEASE, HYPERTHYROIDISM, EXTREME PAIN IN ARMS AND LEGS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, Rheumatoid factor, Thyroxine free, Tri-iodothyronine
Clinical narrative: PROPTOSIS OF THE RIGHT EYE, BLURRY VISION, INFLAMMATION IN EYES, EXTREME PAIN IN EYES, DRY EYES, AUTOIMMUNE DISEASE, HYPERTHYROIDISM, EXTREME PAIN IN ARMS AND LEGS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: PROPTOSIS OF THE RIGHT EYE, BLURRY VISION, INFLAMMATION IN EYES, EXTREME PAIN IN EYES, DRY EYES, AUTOIMMUNE DISEASE, HYPERTHYROIDISM, EXTREME PAIN IN ARMS AND LEGS
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Muscle spasms, Pain, Seizure like phenomena
Clinical narrative: Shingrix vaccine, 10 hrs after injection. Headache,ringing in my ears fatigue and what felt like mini seizures. Also cramping in my hands,calves and feet. Upon waking there was a soreness as if I had had an extensive workout.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: Shingrix vaccine, 10 hrs after injection. Headache,ringing in my ears fatigue and what felt like mini seizures. Also cramping in my hands,calves and feet. Upon waking there was a soreness as if I had had an extensive workout.
Age: 51.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: RSV Abrysvo given to 51 year old male.  Lot number :HN3790 expiration date: 04/30/2025 location: left deltoid Dose: 0.5 ml Manufacturer: Pfizer, Inc. No reported problems from patient. Attempted to contact on 10/01/2024, LVM to call clinic back.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aspiration pleural cavity, Chest X-ray abnormal, Orthopnoea, Pleural effusion, Sleep disorder
Clinical narrative: While feeling like I was experiencing a form of suffocation while lying down, I was unable to sleep. Knowing this was abnormal, my primary care physician was contacted and a request to see a lung and allergy doctor was discussed. After several lung and allergy doctor appointments, chest x-ray evaluations showed fluid in my right lung. That prompted the doctor to order the removable of the fluid at a hospital in June 2023. The doctor who requested the fluid removal acknowledged that he never received a report. I requested the release of my medical record this year 2024 and learned that 700 cc of fluid was extracted. Very concerned about my health and status of the fluid in question, I am still struggling to sleep. Another Pulmonary Doctor was requested starting in April 2024 to continue my health care. Within a short time, x-rays showed a build-up of fluid in my right lung. An order for fluid removal was completed and 1800 cc of pleural effusion was extracted July 1, 2024. The procedure to extract the fluid was done at the hospital. I am still under the care of the Pulmonary doctors.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Cerebrovascular accident, Headache, Heart rate increased, Parkinson's disease
Clinical narrative: Tunnelvison, rapid breathing & Heart rate Three (3) strokes, major headaches Loss of balance.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory rate increased, Tunnel vision
Clinical narrative: Tunnelvison, rapid breathing & Heart rate Three (3) strokes, major headaches Loss of balance.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE. NO ADVERSE OUTCOME
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 68.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Pruritus
Clinical narrative: uncontrollable itching on the abdomen, back, buttocks, scalp and diarrhea
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Vomiting
Clinical narrative: Severe vomiting, chills, sweats, and general feeling like crap.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activated partial thromboplastin time, Blood lactic acid, Blood magnesium, Blood pressure decreased, Brain natriuretic peptide
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Breast discomfort, Breast swelling, Diarrhoea, Differential white blood cell count, Full blood count
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza virus test negative, Metabolic function test, Nausea, Peripheral swelling, Prothrombin time
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Rash, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activated partial thromboplastin time abnormal, Blood culture, Blood lactic acid abnormal, Blood magnesium abnormal, Brain natriuretic peptide abnormal
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Culture urine positive, Diarrhoea, Differential white blood cell count, Full blood count, Haematocrit abnormal
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haemoglobin abnormal, Influenza virus test negative, Lipase normal, Metabolic function test, Nausea
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Thromboelastogram, Troponin abnormal, Urine analysis abnormal
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Patient presented to Urgent Care with complaint of nausea, vomiting, diarrhea.  Right arm swelling and right breast swelling and discomfort. Low Blood pressure and had not taken any morning medications. Rash on right arm and breast and fever.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activated partial thromboplastin time, Blood lactic acid, Blood magnesium, Blood pressure decreased, Brain natriuretic peptide
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Breast discomfort, Breast swelling, Diarrhoea, Differential white blood cell count, Full blood count
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza virus test negative, Metabolic function test, Nausea, Peripheral swelling, Prothrombin time
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pyrexia, Rash, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activated partial thromboplastin time abnormal, Blood culture, Blood lactic acid abnormal, Blood magnesium abnormal, Brain natriuretic peptide abnormal
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Culture urine positive, Diarrhoea, Differential white blood cell count, Full blood count, Haematocrit abnormal
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haemoglobin abnormal, Influenza virus test negative, Lipase normal, Metabolic function test, Nausea
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Thromboelastogram, Troponin abnormal, Urine analysis abnormal
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 77.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Patient was admitted to hospital. Patient presented to  EC with nausea, emesis, and diarrhea. she was unable to keep down any solids for two days after receiving vaccine.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Headache, Immediate post-injection reaction, Muscle spasms
Clinical narrative: Patient states she started having nerve type pain immediately after the injection.  Patient developed increased pain, headache,  arm swelling and on 10/4/24 was treated for a cellulitis. Patient presents to office today with ongoing left arm/shoulder pain and arm spasms  with palpation.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states she started having nerve type pain immediately after the injection.  Patient developed increased pain, headache,  arm swelling and on 10/4/24 was treated for a cellulitis. Patient presents to office today with ongoing left arm/shoulder pain and arm spasms  with palpation.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Injury associated with device
Clinical narrative: Pharmacy Technician was recipient of a needle stick accident after administration of Gardasil vaccine for above patient with the same easy point needle tip used to vaccinate the above patient.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Myalgia, Oropharyngeal pain
Clinical narrative: Red and swollen injection site. Sore throat, muscle aches, fatigue
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient called and said at injection site arm was partially red, hot and itchy, Started morning of 10/7/2024. Patient applied cold to area and relieved some of the symptoms
Age: 17.0
Sex: M
Vaccine: FLU3, MENB
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: pain in right shoulder joint, restricted range of motion, pt has been icing and taking ibuprofen and it is not helping per his mother
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received 12+ formulation
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received 12+ pfizer covid dose
Age: 1.75
Sex: M
Vaccine: FLU3
Symptoms: Nystagmus, Seizure like phenomena, Tremor, Unresponsive to stimuli
Clinical narrative: Patient had three seizure like events where he had horizontal nystagmus, was not responding to parents, and slight bouncing of left hand while left arm was flexed
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: patient received pfizer 12+ formulation
Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event or reaction. Patient was given a 4th set of Pediarix, Hib, and PCV 20 at 9 month well check. Patient was not due for this set and this set is invalid
Age: 9.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Hyperhidrosis, Malaise, Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: Following patient appointment (where she received COVID and HPV vaccines) nursing was paged to front desk where patient was lying on the ground. Patient was alert, pale, and diaphoretic. Per mother, patient had informed her that she was feeling unwell while using the restroom after appointment. Patient began to shake, was not responding, and leaned forward towards mom. Mother caught patient before she fell. Mother carried patient to the front desk for help. Patient reports to nursing that she was able to see and hear the entire time. Patient was oriented and answering questions appropriately. Patient was assisted into exam room and given orange juice and graham crackers with color returning to her face. Patient was assessed by Dr. Patient monitored by nursing for 10 minutes while sitting with resolution of symptoms of dizziness. Blood pressure 101/62 with pulse of 91.  Patient and mother accompanied on a walk around the clinic with patient reporting she felt"normal". Patient was stable when discharged home.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Injection site pruritus, Injection site reaction, Pruritus, Rash
Clinical narrative: Colleague received Flucelvax vaccine at annual hospital flu clinic. Shortly after receiving  (0730) complained of itchy eyes, palms, chest and injection site. Did present with very faint slight red flat rash areas over palms, neck and injection site. Denied any respiratory distress. Administered 25mg orally of Benadryl capsule. @ 0740. Vitals taken every 5 minutes, remained stable 121/84-74-99% room air first round and last round 121/79-71-98% room air. Redness completely resolved by 850am. Slight itching remained to corner of right eye only. Injection site with no redness, swelling or itching. After 1 hr of monitoring and marked improvement, colleague driven home by family member.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Colleague received Flucelvax vaccine at annual hospital flu clinic. Shortly after receiving  (0730) complained of itchy eyes, palms, chest and injection site. Did present with very faint slight red flat rash areas over palms, neck and injection site. Denied any respiratory distress. Administered 25mg orally of Benadryl capsule. @ 0740. Vitals taken every 5 minutes, remained stable 121/84-74-99% room air first round and last round 121/79-71-98% room air. Redness completely resolved by 850am. Slight itching remained to corner of right eye only. Injection site with no redness, swelling or itching. After 1 hr of monitoring and marked improvement, colleague driven home by family member.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Employee came in for their flu shot. He had assistance to fill out his vaccine record and consent. He then received the vaccine. When we went to document this it appears that the patient had an appointment on 09/24/24 where he also received the same flu vaccine. The patient has now received two Afluria vaccines. The employee does not display any issues at this time, but should not have had two of the same flu shot.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: The patient sat down to receive her flu shot. Nurse  informed her that our inventory of Afluria flu vaccine was running low and offered her the preservative-free Flucelvax flu vaccine instead. Patient agreed to receive Flucelvax. Simultaneously more doses of Afluria arrived at the clinic. Other nurses at the clinic began drawing syringes of Afluria from a multi-dose vial. After preparing the Flucelvax, Nurse  administered the dose. Moments later, while in conversation with the patient, the nurse mistakenly took a pre-drawn syringe of Afluria that was just dropped off in the appropriately labeled bin at her station and administered the dose to the patient. The nurse immediately realized the error after administering the second dose. Upon realizing the mistake, Nurse informed the patient of what had occurred. She immediately looked down and saw that she had given one Flucelvax vaccine and one Afluria vaccine. Flucelvax comes in a prefilled labeled syringe, and Afluria is pre-drawn by our nurses. It is therefore easy to identify which was given. Once the on-site pharmacist and clinic lead, was informed, he promptly filed an incident report with both the nurse and the patient. Patient was asked if she required medical attention, which she declined. She was informed of possible side effects, such as fever, chills, and fatigue. A day later, the patient was provided with an email receipt, including the lot numbers for both the Flucelvax and Afluria vaccines that were administered.
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Peripheral swelling, Petechiae
Clinical narrative: a little bit of swelling in feet with smooth red dots under skin, headache
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Cough, Dysphonia, Dyspnoea, Exposure during pregnancy
Clinical narrative: Successful IVF embryo transfer completed 8/23/2024. Positive pregnancy test 9/3/2024. Positive pregnancy test 9/6/2024. Flu vaccine administered 9/10/2024 (early afternoon). Symptoms: watery eyes, headache, body soreness, runny nose, fever, severe fatigue/lethargy, shortness of breath later on the same day (9/10/2024). Symptoms of cough and congestion, sore throat, hoarseness began 9/11/2024. Fever went away 9/11/2024, however, all other symptoms persisted. *Pregnancy symptoms: queasiness, tender breasts were no longer experienced as of 9/11/2024. Pregnancy Test 9/20/2024 positive (Progesterone level), however, Secondary diagnosis of 'miscarriage' noted. Ultrasound 9/27/2024 indicated that two embryos were present, however, they had not grown past 5 weeks, 4 days and 5 weeks, respectively, Embryos should have been 7 weeks, 5 days on that date. According to findings,  Embryos stopped growing/developing on approximately 9/12/2024, two days after administration of Flaurix Influenza Vaccine. Symptoms of cough, shortness of breath, sore throat/hoarseness and mild congestion continue to date.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Lacrimation increased, Lethargy, Oropharyngeal pain
Clinical narrative: Successful IVF embryo transfer completed 8/23/2024. Positive pregnancy test 9/3/2024. Positive pregnancy test 9/6/2024. Flu vaccine administered 9/10/2024 (early afternoon). Symptoms: watery eyes, headache, body soreness, runny nose, fever, severe fatigue/lethargy, shortness of breath later on the same day (9/10/2024). Symptoms of cough and congestion, sore throat, hoarseness began 9/11/2024. Fever went away 9/11/2024, however, all other symptoms persisted. *Pregnancy symptoms: queasiness, tender breasts were no longer experienced as of 9/11/2024. Pregnancy Test 9/20/2024 positive (Progesterone level), however, Secondary diagnosis of 'miscarriage' noted. Ultrasound 9/27/2024 indicated that two embryos were present, however, they had not grown past 5 weeks, 4 days and 5 weeks, respectively, Embryos should have been 7 weeks, 5 days on that date. According to findings,  Embryos stopped growing/developing on approximately 9/12/2024, two days after administration of Flaurix Influenza Vaccine. Symptoms of cough, shortness of breath, sore throat/hoarseness and mild congestion continue to date.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pregnancy test positive, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Successful IVF embryo transfer completed 8/23/2024. Positive pregnancy test 9/3/2024. Positive pregnancy test 9/6/2024. Flu vaccine administered 9/10/2024 (early afternoon). Symptoms: watery eyes, headache, body soreness, runny nose, fever, severe fatigue/lethargy, shortness of breath later on the same day (9/10/2024). Symptoms of cough and congestion, sore throat, hoarseness began 9/11/2024. Fever went away 9/11/2024, however, all other symptoms persisted. *Pregnancy symptoms: queasiness, tender breasts were no longer experienced as of 9/11/2024. Pregnancy Test 9/20/2024 positive (Progesterone level), however, Secondary diagnosis of 'miscarriage' noted. Ultrasound 9/27/2024 indicated that two embryos were present, however, they had not grown past 5 weeks, 4 days and 5 weeks, respectively, Embryos should have been 7 weeks, 5 days on that date. According to findings,  Embryos stopped growing/developing on approximately 9/12/2024, two days after administration of Flaurix Influenza Vaccine. Symptoms of cough, shortness of breath, sore throat/hoarseness and mild congestion continue to date.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: Successful IVF embryo transfer completed 8/23/2024. Positive pregnancy test 9/3/2024. Positive pregnancy test 9/6/2024. Flu vaccine administered 9/10/2024 (early afternoon). Symptoms: watery eyes, headache, body soreness, runny nose, fever, severe fatigue/lethargy, shortness of breath later on the same day (9/10/2024). Symptoms of cough and congestion, sore throat, hoarseness began 9/11/2024. Fever went away 9/11/2024, however, all other symptoms persisted. *Pregnancy symptoms: queasiness, tender breasts were no longer experienced as of 9/11/2024. Pregnancy Test 9/20/2024 positive (Progesterone level), however, Secondary diagnosis of 'miscarriage' noted. Ultrasound 9/27/2024 indicated that two embryos were present, however, they had not grown past 5 weeks, 4 days and 5 weeks, respectively, Embryos should have been 7 weeks, 5 days on that date. According to findings,  Embryos stopped growing/developing on approximately 9/12/2024, two days after administration of Flaurix Influenza Vaccine. Symptoms of cough, shortness of breath, sore throat/hoarseness and mild congestion continue to date.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Nausea
Clinical narrative: Patient went to ER approximately 20 hours after vaccine administration with elevated heart rate, dizziness, nausea- being evaluated for POTS syndrome. Symptoms lasted for 3 days.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Approximately 1-2hrs after the injection, the right upper arm had a hard lump.  Several hours after the injection, the upper portion of the right arm was swollen (shoulder to elbow), warm to the touch, beginning to turn red, the skin was very hard and tender.  Approximately 24 hours after the injection, the swelling spread to the lower portion of the right arm (just below the elbow) and the entire upper arm was red, warm to the touch, very swollen (visually appeared double its normal size), very tender, had limited mobility (due to pain when moving), the skin was hard, and the right shoulder was drooping down.  48 hours after the injection, the redness was starting to fade and the swelling started going down but did continute to spread down to the wrist and the skin still felt very hard.  72 hours after the injection, the redness and tenderness were much better but the entire arm was still a little swollen from shoulder to wrist and the skin was still hard.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth, Pain, Peripheral swelling, Posture abnormal, Skin tightness
Clinical narrative: Approximately 1-2hrs after the injection, the right upper arm had a hard lump.  Several hours after the injection, the upper portion of the right arm was swollen (shoulder to elbow), warm to the touch, beginning to turn red, the skin was very hard and tender.  Approximately 24 hours after the injection, the swelling spread to the lower portion of the right arm (just below the elbow) and the entire upper arm was red, warm to the touch, very swollen (visually appeared double its normal size), very tender, had limited mobility (due to pain when moving), the skin was hard, and the right shoulder was drooping down.  48 hours after the injection, the redness was starting to fade and the swelling started going down but did continute to spread down to the wrist and the skin still felt very hard.  72 hours after the injection, the redness and tenderness were much better but the entire arm was still a little swollen from shoulder to wrist and the skin was still hard.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Skin warm, Tenderness
Clinical narrative: Approximately 1-2hrs after the injection, the right upper arm had a hard lump.  Several hours after the injection, the upper portion of the right arm was swollen (shoulder to elbow), warm to the touch, beginning to turn red, the skin was very hard and tender.  Approximately 24 hours after the injection, the swelling spread to the lower portion of the right arm (just below the elbow) and the entire upper arm was red, warm to the touch, very swollen (visually appeared double its normal size), very tender, had limited mobility (due to pain when moving), the skin was hard, and the right shoulder was drooping down.  48 hours after the injection, the redness was starting to fade and the swelling started going down but did continute to spread down to the wrist and the skin still felt very hard.  72 hours after the injection, the redness and tenderness were much better but the entire arm was still a little swollen from shoulder to wrist and the skin was still hard.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Nausea, Seizure, Syncope
Clinical narrative: Patient fainted after receiving Spikevax vaccine and seeing her son faint and hit his head. She was sitting when it happened. I caught her and lowered her to the ground. She was unconscious for only about 30 seconds. Upon waking, she seemed alert and to know where she was and what was happening. She continued to lay on the ground until the EMTs arrived. the EMTs arrived in a few minutes. Upon sitting, she felt dizzy and nauseas so they took her out in wheelchair. In the parking lot, the patient started having seizures. Her husband reported that she has never had a seizure before. Patient left in an ambulance.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: My arm was sore at the site of injection for 2 weeks.  I thought it had subsided but on 10/3 I have severe pain at the injection site where it hurt to move my arm in any capacity for about 12 hours.  The arm continued to hurt slightly over the next few days.  My daughter works in healthcare research and suggested I report this.
Age: 88.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient requested and received RSV vaccine 10/4/24. However, she had previously received vaccine 10/11/2023
Age: 47.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient called stating she has had severe right shoulder pain for 2 weeks since getting her flu shot and can barely move her arm
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient lost consciousness after receiving his covid vaccine. He fell and hit his head on the wall.  He woke within seconds and was aware of his surroundings and could answer basic questions. EMS was called to evaluate the patient. They arrived in a few minutes and looked at his head and neck. They did not see any issues but took him to the ambulance for further evaluation.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Product administered at inappropriate site
Clinical narrative: Large dark bruise to administration site, administration site not in the deltoid
Age: 77.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Balance disorder, Confusional state, Delirium, Pain
Clinical narrative: Loss of balance, achiness all over, weakness, confusion, delirium
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: THE PATIENT WAS GIVEN THE ENTIRE VIAL OF VACCINE. IT WASN'T UNTIL AFTER GIVING THE VACCINE THAT IT WAS NOTED THAT THIS WAS A 3 DOSE VIAL THAT NEEDED TO BE DILUTED PRIOR TO USE.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Lip pain, Paraesthesia
Clinical narrative: Flu like symptoms the night of the injection with slight fever then "pins and needles" sensation in the face, especially surrounding the sinuses. "raw and sore" upper lip without swelling
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site haemorrhage
Clinical narrative: Severe bruising. Patient also stated extreme bleeding at the time of injection.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: C-reactive protein normal, Contusion, Full blood count abnormal, Hyponatraemia, Injection site discolouration
Clinical narrative: Bruising and tenderness over the area in the first day. Received shot at pharmacy. Saw Urgent Care day 25. Prednisone helped, per patient. Came to our clinic yesterday. Had palpable tender area at injection site and skin discoloration, still, 45 days after injection.
Age: 82.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Leukocytosis, Metabolic function test abnormal, Tenderness
Clinical narrative: Bruising and tenderness over the area in the first day. Received shot at pharmacy. Saw Urgent Care day 25. Prednisone helped, per patient. Came to our clinic yesterday. Had palpable tender area at injection site and skin discoloration, still, 45 days after injection.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Groin pain, Sleep disorder, X-ray normal
Clinical narrative: Excruciating pain in the left groin. Patient lost appetite and couldn't sleep because of the pain. Patient went to ER but ER didn't find any problem with Xray.  Patient went to PCP who prescribed him prednisone. Patient feels better now but still using a cane to get around.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Blister, Full blood count, Joint swelling, Metabolic function test
Clinical narrative: Pain and swelling to bilateral feet and ankles starting 8 days after administration; 4 clear fluid-filled blisters to left ankle starting 9 days after administration.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Urine analysis normal, X-ray limb normal
Clinical narrative: Pain and swelling to bilateral feet and ankles starting 8 days after administration; 4 clear fluid-filled blisters to left ankle starting 9 days after administration.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Sleep disorder
Clinical narrative: Intense itch left upper extremity - woke me up. Itching then spread to upper back and right forearm. Injection was to my left deltoid. My first Novavax was administered November 17, 2023. The first dose was not problematic other than a sore arm. Prior to that I had received three Moderna injections with unpleasant side effects. Benadryl 50 mg po taken near 4:00 AM on 10/08/24 calmed the reaction. No respiratory symptoms. Itch resolved as of this reporting time.