chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: her niece died due to the vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient 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: DEATH (death, medically significant), outcome "fatal", described as "her niece died due to the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical Course: The reporter was concerned about the  safety and efficacy of the Pfizer COVID-19 vaccine, alleging that it contains cancer-causing ingredients and has resulted in numerous deaths. Also enquired, why vaccine was distributed despite reports of adverse effects, including deaths allegedly linked to cancer and other serious illnesses. The reporter further stated concerns on individuals who have experienced adverse reactions. Also stated that her niece died due to the vaccine.; Reported Cause(s) of Death: her niece died due to the vaccine
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Hyperhidrosis, Malaise
Clinical narrative: left arm is very sore and hurts me to lift it; did not feel well; chills; sweats; weak; lightheaded /almost fainted; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Apr2024 as dose unknown (booster), 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: CHILLS (non-serious) with onset 22Apr2024, outcome "unknown"; MALAISE (non-serious) with onset 22Apr2024, outcome "unknown", described as "did not feel well"; DIZZINESS (non-serious) with onset 22Apr2024, outcome "unknown", described as "lightheaded /almost fainted"; HYPERHIDROSIS (non-serious) with onset 22Apr2024, outcome "unknown", described as "sweats"; ASTHENIA (non-serious) with onset 22Apr2024, outcome "unknown", described as "weak"; PAIN IN EXTREMITY (non-serious) with onset 24Apr2024, outcome "unknown", described as "left arm is very sore and hurts me to lift it". Additional information: Patient reported that the evening of the injection, she did not felt well and experienced chills and sweats. During the night, she became very weak and lightheaded to the point she almost fainted. Then, on 24Apr2024, her left arm was very sore and hurts to lift it.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm is very sore and hurts me to lift it; did not feel well; chills; sweats; weak; lightheaded /almost fainted; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Apr2024 as dose unknown (booster), 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: CHILLS (non-serious) with onset 22Apr2024, outcome "unknown"; MALAISE (non-serious) with onset 22Apr2024, outcome "unknown", described as "did not feel well"; DIZZINESS (non-serious) with onset 22Apr2024, outcome "unknown", described as "lightheaded /almost fainted"; HYPERHIDROSIS (non-serious) with onset 22Apr2024, outcome "unknown", described as "sweats"; ASTHENIA (non-serious) with onset 22Apr2024, outcome "unknown", described as "weak"; PAIN IN EXTREMITY (non-serious) with onset 24Apr2024, outcome "unknown", described as "left arm is very sore and hurts me to lift it". Additional information: Patient reported that the evening of the injection, she did not felt well and experienced chills and sweats. During the night, she became very weak and lightheaded to the point she almost fainted. Then, on 24Apr2024, her left arm was very sore and hurts to lift it.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Decreased immune responsiveness, Illness
Clinical narrative: Your booster made me extremely sick; I lost my hair; I lost my hair. My immunity; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "Your booster made me extremely sick"; ALOPECIA (non-serious), outcome "unknown", described as "I lost my hair"; DECREASED IMMUNE RESPONSIVENESS (non-serious), outcome "unknown", described as "I lost my hair. My immunity".  Additional information: The booster made her extremely sick and she is still suffering. She contacted about this before and sent her 100 pages to fill out. She refused to fill them out. She indicated: "I lost my hair. My immunity. Send me to a doctor"
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Incorrect route of product administration
Clinical narrative: Got COVID despite vaccination; Got COVID despite vaccination; Route: subcutaneously; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old female patient received BNT162b2 (BNT162B2), in Jul2021 as dose number unknown, single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2021, outcome "recovered" (Jul2021) and all described as "Got COVID despite vaccination"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset Jul2021, outcome "unknown", described as "Route: subcutaneously".  Clinical course: Got COVID despite vaccination but had a very mild case that subsided within three days.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got COVID-19 twice actually, once before and once after I got the shots; I got COVID-19 twice actually, once before and once after I got the shots; This is a spontaneous report received from a Consumer or other non HCP.  A 33-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "I got COVID-19 twice actually, once before and once after I got the shots".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Flushing, Injection site reaction, Pruritus, Rash
Clinical narrative: 3/11/24-Patient received #2 varicella vaccine 10am. At 11:20am she returned to employee health. She was feeling flushed, red skin generalized hand to trunk area, rash, itching whelps on back and @ injection area. She denied any respiratory problems or SOA. No swelling noted of airway. She was given Benadryl 25mg po on floor. The area of injection was not hot. V.S T. 97.4 P. 97, R. 20 B/P 126/85, O2 Sat 98%. She stated "she didn't have any issues with last vaccine. She was discharge to urgent care. Seen @ Urgent Care. At time of exam symptoms almost completely resolved. No oral swelling. Assessment, Vaccine Reaction continue Benadryl as needed. Drink plenty of fluids. Followup in clinic or ER if symptoms worsen or change.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: 3/11/24-Patient received #2 varicella vaccine 10am. At 11:20am she returned to employee health. She was feeling flushed, red skin generalized hand to trunk area, rash, itching whelps on back and @ injection area. She denied any respiratory problems or SOA. No swelling noted of airway. She was given Benadryl 25mg po on floor. The area of injection was not hot. V.S T. 97.4 P. 97, R. 20 B/P 126/85, O2 Sat 98%. She stated "she didn't have any issues with last vaccine. She was discharge to urgent care. Seen @ Urgent Care. At time of exam symptoms almost completely resolved. No oral swelling. Assessment, Vaccine Reaction continue Benadryl as needed. Drink plenty of fluids. Followup in clinic or ER if symptoms worsen or change.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Oropharyngeal pain, Pain in extremity, Pain in jaw, Pharyngeal swelling, Swelling face
Clinical narrative: patient described soreness in right arm (arm opposite of injection arm), as well as swelling/soreness in right throat/jaw area on the day following the vaccinations. she came to the pharmacy and purchased otc ibuprofen to use for the soreness/swelling.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adacel was administered instead of Boostrix..
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Kinrix (Dtap/IPV combo) given in error out side of licensing guidelines. Was only patient 4th Dtap
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Gait inability, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: quadraplegia, IVIG, plasmapheresis, 6 months of PT/OT, still unable to walk or lift any weight with arms at month 6
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Mobility decreased, Musculoskeletal disorder, Plasmapheresis, Quadriplegia
Clinical narrative: quadraplegia, IVIG, plasmapheresis, 6 months of PT/OT, still unable to walk or lift any weight with arms at month 6
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: quadraplegia, IVIG, plasmapheresis, 6 months of PT/OT, still unable to walk or lift any weight with arms at month 6
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Patient came into the pharmacy 4/30/24 asking if it was normal to still be having arm pain after the immunization. He said his arm was hurting from the shoulder down into his forearm since the vaccine was given in November. I advised patient to see his doctor to get assessed for the arm pain.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Deafness unilateral, Dizziness, Magnetic resonance imaging abnormal
Clinical narrative: Sudden loud ringing in right ear followed my near total hearing loss for approximately 6 hrs. Then 6 days after vaccine had severe vertigo/dizziness causing overnight hospital stay
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Vertigo positional
Clinical narrative: Sudden loud ringing in right ear followed my near total hearing loss for approximately 6 hrs. Then 6 days after vaccine had severe vertigo/dizziness causing overnight hospital stay
Age: 40.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling
Clinical narrative: Large swelling at injection site one week post injection
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 69.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt called on 4/25/2024 after receiving a letter in the mail from our health department stating that her dose of MMRV was an invalid dose and was reimbursed a $10.00 vaccine fee.  Pt denies any side effects but needed further instruction about a repeat MMR dose.  Pt was born before 19XX and had mumps in childhood and was told that she was most likely immune and did not need any further MMR's.  Pt had been vaccinated with the shingle series in 2018.    MA was the staff person who gave the immunization.
Age: 69.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt called on 4/25/2024 after receiving a letter in the mail from our health department stating that her dose of MMRV was an invalid dose and was reimbursed a $10.00 vaccine fee.  Pt denies any side effects but needed further instruction about a repeat MMR dose.  Pt was born before 19XX and had mumps in childhood and was told that she was most likely immune and did not need any further MMR's.  Pt had been vaccinated with the shingle series in 2018.    MA was the staff person who gave the immunization.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: HCP did not report any side effects from the inadvertent administration of the third dose of PROQUAD vaccine; a 5 year old female patient was inadverntly administered a third dose of the PROQUAD vaccine; This spontaneous report was received from a Nurse and refers to a 5-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date (reported as in June, no further information), the patient was vaccinated with the second dose of started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and route of administration were not provided). On 23-APR-2024, the patient was inadvertently vaccinated with a third dose of started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, Lot # reported as X0211231 which was determined to be an invalid lot number by the validation lot team, expiration date reported as 12-FEB-2025 (strength and route of administration were not provided). The third dose was administered because the state database did not upload the patient's second dose of the vaccine (Extra dose administered). The reporter did not report any side effects from the inadvertent administration of the third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) vaccine (No adverse event). HCP provided limited pertinent information and had no further clarifications. Operator of device was reported as health professional. No additional adverse event or product quality complaint reported.  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: all the other 4 were good and did not really have any problems with those, maybe a little pain; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing). Concomitant medication(s) included: ACLOMORE P taken for arthritis. The following information was reported: PAIN (non-serious), outcome "unknown", described as "all the other 4 were good and did not really have any problems with those, maybe a little pain".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Nerve injury, Pain
Clinical narrative: all the other 4 were good and did not really have any problems with those, maybe a little pain; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing). Concomitant medication(s) included: ACLOMORE P taken for arthritis. The following information was reported: PAIN (non-serious), outcome "unknown", described as "all the other 4 were good and did not really have any problems with those, maybe a little pain".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Joint range of motion decreased, Myalgia, Nerve injury
Clinical narrative: all the other 4 were good and did not really have any problems with those, maybe a little pain; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing). Concomitant medication(s) included: ACLOMORE P taken for arthritis. The following information was reported: PAIN (non-serious), outcome "unknown", described as "all the other 4 were good and did not really have any problems with those, maybe a little pain".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: all the other 4 were good and did not really have any problems with those, maybe a little pain; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing). Concomitant medication(s) included: ACLOMORE P taken for arthritis. The following information was reported: PAIN (non-serious), outcome "unknown", described as "all the other 4 were good and did not really have any problems with those, maybe a little pain".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: I took Gardasil 9 msd and kept it in the fridge. It has been cold for two days, around -2 to +2 degree; No adverse event; This spontaneous report was received from a consumer concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown.    The reporter stated: I took hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and kept it in the fridge. It had been cold for two days, around -2 to +2 degree Celsius, I want to know the vaccine was damaged? Was it possible to use these vaccines? (Product storage error). No additional AE reported. No PQC.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; Caller reported expired VARIVAX was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 15-JAN-2024, the patient was vaccinated with an expired dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W012165, expiration date: 12-APR-2024, administered subcutaneously for prophylaxis (strength was not provided), diluted with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, 0.5 milliliter, formulation: vial, lot #X002651, expiration date: 13-SEP-2025 (strength, route of administration, and indication were not provided) (Expired product administered). No additional adverse event was reported.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received first dose of GARDASIL 9 at age 9 and second dose at age 14; No additional AE; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date at 9-years-old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and at 14-year-old with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). No adverse events reported.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Flushing, Localised oedema
Clinical narrative: Facial flush and localised oedema with erythema  extending shoulder to elbow. self treated with  oral Ibuprofen 400mg  and Phenylephrine Hydrochloride 5 mgs x 4hrly x  24hrs,  graduated dose  reduction  further 24hrs. Complete resolve  x 4 days.  no compromised airways.
Age: 17.0
Sex: F
Vaccine: HPV9, IPV, MENB, MNQ
Symptoms: Exposure during pregnancy, Malaise
Clinical narrative: EDD: 06/17/2024. Patient called with complaints of generally not feeling well and having to manage symptoms with Tylenol. Patient is aware that the clinic that was called was not the vaccinating clinic, but is the clinic providing OB care. Patient stated that she was concerned that she received 4 vaccines rather than the one that she had been told she was receiving and did not know if that was the reason she did not feel well.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Rash pruritic
Clinical narrative: Pt reports the next day after the vaccine she broke out in a upper body rash. To include her arms, hands, palms, back and neck. Pt. presented to clinician with a pruritic rash to arms, hands, palms of hands, neck, upper back and torso. Pt was given a injection IM of Dexamethasone. Pt prescribed steroid cream
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Paraesthesia, Swelling, Urticaria
Clinical narrative: Diffuse swelling , tingling, shortness of breath, HIVs, recurrent
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted.
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Erythema, Irritability, Urticaria, Vomiting
Clinical narrative: Per mom, patient woke @ 5am on 5/1/24 with fussiness and a hive in diaper area.  After feeding, vomited entire bottle.  Evaluated by Dr. at 0815 on 5/1/25.  Redness and swelling noted on both lower arms, hives on abdomen and back.  Benadryl and Tylenol given in office.  Instructed mom to give Benadryl every 6-8 hours for next 24 hours and return to office on 5/3/24 and go to ER for any facial swelling, worsening of symptoms, or difficulty breathing.  Symptoms improving by end of clinic visit.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccines frozen instead of refrigerated
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of being refrigerated
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigered
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects known
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired no symptoms
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired, no adverse effects noted
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC20, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given to 4 Month old
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of refrigerated
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Acute kidney injury, Acute respiratory failure, Aphasia, COVID-19, Cognitive disorder
Clinical narrative: Shaking, Fever over 100 degrees, icy cold, sweating, nervous, couldn?t talk, couldn?t walk, was incoherent, mind not functioning correctly, don?t recall when EMT got here, don?t recall when they took me to the hospital, don?t recall emergency room doctor or nurses, really had acute alteration in mental status. Had acute COVID-19. Had acute Ipoxis respiratory failure. Had acute kidney injury.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Computerised tomogram, Feeling cold, Gait inability, Hyperhidrosis, Incoherent
Clinical narrative: Shaking, Fever over 100 degrees, icy cold, sweating, nervous, couldn?t talk, couldn?t walk, was incoherent, mind not functioning correctly, don?t recall when EMT got here, don?t recall when they took me to the hospital, don?t recall emergency room doctor or nurses, really had acute alteration in mental status. Had acute COVID-19. Had acute Ipoxis respiratory failure. Had acute kidney injury.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Memory impairment, Mental status changes, Nervousness, Tremor
Clinical narrative: Shaking, Fever over 100 degrees, icy cold, sweating, nervous, couldn?t talk, couldn?t walk, was incoherent, mind not functioning correctly, don?t recall when EMT got here, don?t recall when they took me to the hospital, don?t recall emergency room doctor or nurses, really had acute alteration in mental status. Had acute COVID-19. Had acute Ipoxis respiratory failure. Had acute kidney injury.
Age: 84.0
Sex: M
Vaccine: UNK
Symptoms: X-ray
Clinical narrative: Shaking, Fever over 100 degrees, icy cold, sweating, nervous, couldn?t talk, couldn?t walk, was incoherent, mind not functioning correctly, don?t recall when EMT got here, don?t recall when they took me to the hospital, don?t recall emergency room doctor or nurses, really had acute alteration in mental status. Had acute COVID-19. Had acute Ipoxis respiratory failure. Had acute kidney injury.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of frigerated
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Body temperature increased, Haematochezia, Occult blood positive
Clinical narrative: Patient was vaccinated as part of a routine two month well child visit on 04/29/2024 where they received two month vaccines including pediarix, pedvax HIB, prevnar 20, and rotateq. Mother sent a message via patient portal on 04/30/2024 asking if it was normal for the child to have blood in the stool following vaccination. Triage RNs contacted the mother who reported that the patient did not seem to be in any pain and is eating well and having good wet diapers. Mother reported he did have a temperature with Tmax 101.5 on 04/29/2024 following vaccination and voiced understanding of how to monitor for pain, fever, or discomfort and will take him to be evaluated if she noticed those. Patient was seen at 8:45am on 05/01/2024 by Dr. and two hemoccult tests were performed with both returning positive for blood; a different diaper was used for sample on each hemoccult. Dr. educated the mother on signs of worsening condition and signs of intussusception and mother voiced comfort and understanding with what to do if she noticed these signs. Plan is to watch and wait with strict return precautions and patient will not receive rotavirus vaccination at 4mo or 6mo well child visits.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted. The pfizer vaccine administered was being stored in freezer at -25 degrees C.  Per manufacture vaccine is non viable.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine  was frozen instead of refrigerated
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no adverse effects noted
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Sore Arm. Patient was advised to apply ice pack and treat pain with ibuprofen and acetaminophen.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Induration
Clinical narrative: Patient returned on 5/1/24 to show a three inch bruise with hard spot, that she thinks was from vaccine.   She may have injured other way.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was frozen instead of refrigerated
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted. The pfizer vaccine administered was being stored in freezer at -25 degrees C.  Per manufacture vaccine is non viable.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Eye swelling, Streptococcus test negative, Urticaria
Clinical narrative: Hives to right side face, swollen right eye Treated with Prednisone 40 mg once time dose and Diphenhydramine 50 mg po once.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site bruising, Injection site discolouration, Injection site dryness, Injection site nodule, Injection site pain
Clinical narrative: She got her vaccine, and it hurt at the injection site, but it was fine.  The gentleman giving her the shot was very gentle.   She was told to rub the arm, and a week after that her sister noticed a bruise on the arm.  Two weeks after the shot, last week the bruise started to turn black, and it was big.  She used ice packs on it as it hurt so bad that she could barely move it and was extremely tender to touch with a knot in it.  She is a caregiver and lifting people did not help with the pain.  The area where the bruising is a lot larger than the injection site, about 1/2 dollar in size.  Looks like an upside down cloud.  She has also been taking Tylenol for the pain.  She has not contacted her doctor.  Her cousin is a nurse and she told her to see the pharmacist, she went to the pharmacy and they told her to call us.  It was warm to touch and it itches a lot, and puts lotion on it as the skin around it is real dry and peeling.  It has improved though, but the bruise is still present.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Pain, Skin exfoliation
Clinical narrative: She got her vaccine, and it hurt at the injection site, but it was fine.  The gentleman giving her the shot was very gentle.   She was told to rub the arm, and a week after that her sister noticed a bruise on the arm.  Two weeks after the shot, last week the bruise started to turn black, and it was big.  She used ice packs on it as it hurt so bad that she could barely move it and was extremely tender to touch with a knot in it.  She is a caregiver and lifting people did not help with the pain.  The area where the bruising is a lot larger than the injection site, about 1/2 dollar in size.  Looks like an upside down cloud.  She has also been taking Tylenol for the pain.  She has not contacted her doctor.  Her cousin is a nurse and she told her to see the pharmacist, she went to the pharmacy and they told her to call us.  It was warm to touch and it itches a lot, and puts lotion on it as the skin around it is real dry and peeling.  It has improved though, but the bruise is still present.
Age: 31.0
Sex: F
Vaccine: FLU4, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Pt. stated to receive vaccine on April 9th, 2024 and had redness, rashes, and swelling on April 11th 2024
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Laboratory test, Pain, Pain in extremity
Clinical narrative: Numbness in figers, body aches-upper arm; lower leg
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, HEPA, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted. The pfizer vaccine administered was being stored in freezer at -25 degrees C.  Per manufacture vaccine is non viable.
Age: 0.33
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Diarrhoea, Haematochezia, Imaging procedure abnormal, Intussusception
Clinical narrative: The patient developed vomiting and diarrhea the days after vaccine administration, abdominal pain, and a bloody stool. He presented to the Hospital Emergency department, and was diagnosed with intussusception .
Age: 0.33
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: The patient developed vomiting and diarrhea the days after vaccine administration, abdominal pain, and a bloody stool. He presented to the Hospital Emergency department, and was diagnosed with intussusception .
Age: 1.75
Sex: M
Vaccine: MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: My co-worker had ask for my help giving injections to the patient and his sibling, I helped her pull the vaccines and was signing off varying that they were correct. We went in and gave the vaccines, when coworker went to document them she noticed by putting them in our system that we had given the wrong MMR to the patient. We called our manager immediately and made her aware and she told us, she would handle it with the mom and reporting it. My manager then pulled me aside today stated the patient was doing fine and that I needed to report it here.
Age: 57.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient made appointment online for an influenza and covid vaccine.  He entered his birthday as 04/XX/19XX, which would've made him 67 years old on date of administration. NP verified patient's birthday and name prior to vaccine administration. High dose flu vaccine given. It was discovered at a later date that patient's birthday was 4/XX/19XX, therefore, he would've only been 57 years old on date of administration and should have received a non-high dose flu vaccine.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient came in Thursday April 25th and was given the wrong COVID dose. She received a dose meant for a 12yr+. Mother of patient was advised of matter and patient was monitored. No severe reaction occurred to patient and she went home just fine. Vaccine coordinator was also advised of this matter.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Benign prostatic hyperplasia, Bereavement, COVID-19 pneumonia, Hypoxia
Clinical narrative: Hospitalization for COVID-19 pnuemonia with hypoxemia, Atrial fibrillation, BPH, bereavement on dates 4/11/24- 4/25/24. Treated with dexamethasone, methylprednisolone, and Remdesivir.
Age: 94.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administration error: Administered duplicate RSV vaccination. Dose 1 was administered on 10/30/23. Dose 2 administered on 1/29/24. No known adverse events from administration error. Error discovered by Immunization Registry since they had duplicate entries in their database. They called our pharmacy to confirm we did give error dose on 1/29/24 and requested we submit VAERS report.
Age: 30.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given for the wrong age group.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Death
Clinical narrative: Passed away in sleep.  Dad found him face up in crib.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Dyspnoea, Feeling of body temperature change, Nausea, Palpitations
Clinical narrative: Arm turned blotchy red, swollen and very hot.  My heart was racing very fast and I would go from hot to cold very quickly.  I was having a difficult time breathing.  When I tried to get up to go to the bathroom, it was almost like having vertigo and I was sick to my stomach.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Rash macular, Skin warm
Clinical narrative: Arm turned blotchy red, swollen and very hot.  My heart was racing very fast and I would go from hot to cold very quickly.  I was having a difficult time breathing.  When I tried to get up to go to the bathroom, it was almost like having vertigo and I was sick to my stomach.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Fever followed by redness, swelling, pain, raised large area on right arm, just below deltoid muscle; then joint and muscle pain in right shoulder/neck/head moving to left shoulder to lower back bilaterally then down left leg, following what felt like nerve pain, especially concentrated in lower back and left leg, flu-like symptoms (still have some swelling in arm and itch in area of reaction), Monday night (72 hours post-vaccination) had esophageal spasms and had them again Tuesday night twice
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Myalgia, Neck pain
Clinical narrative: Fever followed by redness, swelling, pain, raised large area on right arm, just below deltoid muscle; then joint and muscle pain in right shoulder/neck/head moving to left shoulder to lower back bilaterally then down left leg, following what felt like nerve pain, especially concentrated in lower back and left leg, flu-like symptoms (still have some swelling in arm and itch in area of reaction), Monday night (72 hours post-vaccination) had esophageal spasms and had them again Tuesday night twice
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Oesophageal spasm, Pain in extremity, Pyrexia
Clinical narrative: Fever followed by redness, swelling, pain, raised large area on right arm, just below deltoid muscle; then joint and muscle pain in right shoulder/neck/head moving to left shoulder to lower back bilaterally then down left leg, following what felt like nerve pain, especially concentrated in lower back and left leg, flu-like symptoms (still have some swelling in arm and itch in area of reaction), Monday night (72 hours post-vaccination) had esophageal spasms and had them again Tuesday night twice
Age: 92.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administration error: Administered duplicate RSV vaccination. Dose 1 was administered on 10/20/23. Dose 2 administered on 12/13/23. No known adverse events from administration error. Error discovered by Immunization Registry Information System since they had duplicate entries in their database. They called our pharmacy to confirm we did give error dose on 12/13/23 and requested we submit VAERS report.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Mother brought the patient in on 04/30/2024 for a vaccine reaction. Mother reported a red circle rash near the vaccine site. Warm to the touch and sensitive to touch.
Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Chest X-ray, Chills, Computerised tomogram thorax, Confusional state, Hypoxia
Clinical narrative: fevers, shaking chills, confusion, hypoxia requiring o2, thrombocytopenia
Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Laboratory test, Pyrexia, Thrombocytopenia, Tremor
Clinical narrative: fevers, shaking chills, confusion, hypoxia requiring o2, thrombocytopenia
Age: 56.0
Sex: F
Vaccine: HEP, VARCEL, VARZOS
Symptoms: No adverse event
Clinical narrative: no adverse events.  varicella and shingrix may have been given on the same day, or more likely it was a scanning error that was not immediately caught and corrected.  since it could not be proven VAERS is being filed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of reirrigated
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Soreness that comes and goes, does not interfere or limit range of motion, but it is definitely noticeable, especially during exercises that use muscles in that area.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of refrigeted
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: No adverse event
Clinical narrative: Patient administered vaccine at 12:40PM, no adverse reactions, both patient and provider were notified, no treatment needed at this time
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of refrigerated
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received the 1st and 2nd dose of HepB- Engerix, 1 ml at the age of 18 by two different nurses, and 3rd dose given by this reporter at the age of 19. No adverse reactions or events after administration.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was frozen instead of refrigerated
Age: 32.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Product administered at inappropriate site
Clinical narrative: Pain, Redness, Swelling & Warm. Went to the doctor and doctor said Cellulitis. Also went to pharmacist and apparently it was injected lower than the deltoid muscle..
Age: 32.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Swelling
Clinical narrative: Pain, Redness, Swelling & Warm. Went to the doctor and doctor said Cellulitis. Also went to pharmacist and apparently it was injected lower than the deltoid muscle..
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of refrigerated
Age: 1.42
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccination ordered was DTap (Infarix) and vaccination administered to patient was Tdap (Boostrix). Pharmacy was contacted and referred to CDC recommendations, which are that it was considered an "underdose". Patient's mother was contacted and asked about patient's status. She stated that patient is showing no signs of an adverse outcome or any symptoms and that patient is at base line. Mother notified of variance and need to have patient return to clinic to receive the DTap per CDC recommendation. Mother also encouraged to call if any symptoms or variance from baseline occurs and to seek ED treatment if emergent symptoms occur.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given was expired, no symptoms
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired , no symptoms
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of refrigerated
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead of refrigerated
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine was frozen instead of refrigerated
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: vaccine frozen instead refrigerated
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix is recommended for children from 4 through 6 yrs. of age. Patient was 3 yrs. old at time of vaccination.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: reactive axillary lymph node swelling that patient noted 5 days after injection on the side the injection was given.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after expiration date.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Myalgia, Urticaria
Clinical narrative: Urticaria, myalgias
Age: 58.0
Sex: F
Vaccine: HEPAB, PNC20, TDAP, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Patient reported left arm pain at redness at injection site starting the night of injection.  She reported a hard lump developing and redness spreading with heat palpable from redness.  After worsening symptoms, she called pharmacy 4/30, and we advised her to see a doctor.  She reported today that the doctor diagnosed her with cellulitis, and she was prescribed antibiotics.
Age: 58.0
Sex: F
Vaccine: HEPAB, PNC20, TDAP, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient reported left arm pain at redness at injection site starting the night of injection.  She reported a hard lump developing and redness spreading with heat palpable from redness.  After worsening symptoms, she called pharmacy 4/30, and we advised her to see a doctor.  She reported today that the doctor diagnosed her with cellulitis, and she was prescribed antibiotics.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Deep vein thrombosis, Peripheral swelling
Clinical narrative: Patient developed right arm swelling within 24 hours and was diagnosed with RUE DVT that day after presenting to the doctor. No symptoms prior to vaccine.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Hypersomnia, Somnolence
Clinical narrative: Excessive amount of sleep,  12-18 hours a sleep a day,  constantly falling asleep, symptoms of narcolepsy, difficulty staying awake
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted. The pfizer vaccine administered was being stored in freezer at -25 degrees C.  Per manufacture vaccine is non viable.
Age: 2.0
Sex: F
Vaccine: FLU4, HIBV, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted. The pfizer vaccine administered was being stored in freezer at -25 degrees C.  Per manufacture vaccine is non viable.
Age: 2.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse reaction noted. The pfizer vaccine administered was being stored in freezer at -25 degrees C.  Per manufacture vaccine is non viable.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events - patient received two doses of single dose vaccine
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chills, Computerised tomogram, Full blood count, Headache
Clinical narrative: Patient is a 37-year-old male presents to the emergency department with fever.  Patient has history of TBI and short-term memory dysfunction, mother at bedside and provides a history.  Patient was recently admitted at facility from 4/10 to 4/25 for a left hip abscess.  This required I&D and IV antibiotics.  Patient was discharged to facility.  Finished antibiotics.  Patient was found to be hypoxic today with a fever of 100.9.  Tachycardic as well.  Mother notes his tremor has also become worse.  Patient complaining of a headache and chills.  He arrived on 2 L of oxygen.  Denies chest pain or shortness of breath.  Denies cough, abdominal pain.  Denies pain at his I&D site.