chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: reported that an expired dose of acthib was administered to a patient with no reported adverse event; Initial information received on 12-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15-month-old male patient and the reporter reported that an expired dose of HIB (PRP/T) vaccine [ACT-HIB] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination; and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Prophylactic vaccination.  On 06-Mar-2024, the patient received a dose 4 of 0.5 ml dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown) (lot: UJ835AB, expiry date: 22-Feb-2024) via intramuscular route in the left vastus lateralis for immunization and reporter reported that an expired dose of acthib was administered to a patient with no reported adverse event (expired product administered) (latency: same day)   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: Back pain, Gait disturbance, Inflammation
Clinical narrative: affected his gait or ability to walk; lower back was starting to hurt periodically; Initial information received on 13-Mar-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age male patient who experienced lower back was starting to hurt periodically and affected his gait or ability to walk after receiving Rabies (Hdc) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine polysacch vi (typhim vi) for immunisation; and meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi) for Immunisation.  On 06-Mar-2024, the patient received 0.5 ml of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (with an unknown strength, expiry date, lot number) via unknown route in the left arm for immunization.  On 07-Mar-2024, the patient developed event of lower back was starting to hurt periodically (back pain) (latency: 1 day).  On an unknown date, the patient developed event of affected his gait or ability to walk (gait disturbance) (unknown latency).  It was reported, Nurse said that the vaccine injected on the right arm of the patient was actually TYPHIM VI and not the IMOVAX. The IMOVAX was actually administered on the left arm of the patient. Nurse reported the symptoms that the patient had over the weekend. The patient informed that their right arm was still inflamed 4 days later, their lower back was starting to hurt periodically but he does not have it normally. This affected his gait or ability to walk and patient said he felt like his back was going to give out. Patient already received IMOVAX last Wednesday (06MAR2024) and was due for the second dose today (13MAR2024) and was scheduled to be given another vaccine today (YF-VAX).Nurse just wanted to clarify as she mispoke during the first case that IMOVAX wad given in the right arm of the patient but it was actually on the left arm. It was TYPHIM VI administered in the right arm together with MENQUADFI.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event lower back was starting to hurt periodically and was Unknown for the event affected his gait or ability to walk.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: administered with an extra dose of Haemophilus vaccine with no reported adverse event; Initial information received  on 13-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient who had administered with an extra dose of Haemophilus B Conjugate Vaccine and also received diphtheria/tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine [pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine And Pneumococcal Vaccine for Prophylactic vaccination.  On 06-Mar-2024, the patient received a dose 1 at a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 31-Mar-2024 and lot UJ865AA via intramuscular route in unknown administration site; also received unknown dose of suspect Haemophilus B Conjugate Vaccine not produced by Sanofi Pasteur (strength, expiry date, formulation and lot number: not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization) (extra dose administered) (same day latency). Information on the batch number was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.17
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 14 month old patient who received QUADRACEL vaccine, with no reported adverse event; Initial information received on 13-Mar-2024 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 14-month-old male patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine INACT (HAVRIX) for Prophylactic vaccination; and measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 13-Mar-2024, the patient received a 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, Suspension for injection (strength, lot number, expiry date) via intramuscular route in the thigh nos for immunization and a 14-month-old patient who received quadracel vaccine, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: patient has been vaccinated with expired vaccine with no adverse event; Initial information received on 14-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age male patient who has been vaccinated with expired Typhoid Vi Polysaccharide Vaccine [Typhim Vi] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Typhoid Vi Polysaccharide Vaccine Solution for injection  (expiry date: 27-Feb-2024) (with an unknown strength, lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient has been vaccinated with expired Typhoid Vi Polysaccharide Vaccine [Typhim Vi] with no adverse event (expired product administered) (latency: same day).  It was reported, Medical assistant called to verify the expiration date format for TYPHIM VI. Expiration date listed on their vaccine is "27Feb24". Confirmed with caller that the vaccine expiration date format is DDMMMYY. Caller then asked that if there are any precautions if a patient has been vaccinated with expired vaccine or if they should just revaccinate. This situation is pre-assessed as a medication error/an inappropriate use due to patient was administered with an expired vaccine. No additional information obtained at the time of the report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired act -hib was administered to a patient with no reported adverse event; Initial information received on 14-Mar-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old male patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 06-Mar-2024, the patient received 0.5 ml dose of expired suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UJ835AB via intramuscular route in unknown administration site for immunization, with no reported adverse event (expired product administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated, Depression, Disorientation
Clinical narrative: My father had the vaccine on the evening of March 12th and next morning he woke up disoriented. He had great difficulty going to the bathroom and he came back and slid off the bed and fell to the floor. It happened twice that day. he also started complaining of pain in the knee and ankles . We put ice, gave Tylenol etc all day. Next day pain got worse and he could not step on to his left leg. Extremely painful knee. It became a nightmare taking him to the toilet etc. He was mostly bed ridden. We called clinic where he goes for care and spoke to 2 nurses (one RN and one RNP) . The RNP advices to call EMS and take him if he is unable to walk by next day. Next day it is slightly better but today is day 6 and the pain is still unbearable. He is depressed and bed bound. He hardly walks and for fear of going to restroom is not drinking as much water. He is also forced to wear adult diapers due to this. Tomorrow we have a phone appointment with a PCP and on Wednesday an orthopedic appointment to see if they can help. This is so unexpected and we feel so guilty for getting him this vaccine. All our lives became hell in a matter of days. I want others to be aware of this. Doctor has been asking me for 3 years to get him shingrix vaccine and so finally I did although I read the side effects. We never expected this harsh flare up of joint pain and make his existing arthritis pain increase exponentially. This is inhuman and cruel.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Gait disturbance, Mobility decreased, Weight bearing difficulty
Clinical narrative: My father had the vaccine on the evening of March 12th and next morning he woke up disoriented. He had great difficulty going to the bathroom and he came back and slid off the bed and fell to the floor. It happened twice that day. he also started complaining of pain in the knee and ankles . We put ice, gave Tylenol etc all day. Next day pain got worse and he could not step on to his left leg. Extremely painful knee. It became a nightmare taking him to the toilet etc. He was mostly bed ridden. We called clinic where he goes for care and spoke to 2 nurses (one RN and one RNP) . The RNP advices to call EMS and take him if he is unable to walk by next day. Next day it is slightly better but today is day 6 and the pain is still unbearable. He is depressed and bed bound. He hardly walks and for fear of going to restroom is not drinking as much water. He is also forced to wear adult diapers due to this. Tomorrow we have a phone appointment with a PCP and on Wednesday an orthopedic appointment to see if they can help. This is so unexpected and we feel so guilty for getting him this vaccine. All our lives became hell in a matter of days. I want others to be aware of this. Doctor has been asking me for 3 years to get him shingrix vaccine and so finally I did although I read the side effects. We never expected this harsh flare up of joint pain and make his existing arthritis pain increase exponentially. This is inhuman and cruel.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Aphonia, Cough, Throat clearing, Throat irritation
Clinical narrative: Hours after the shot , I began to get a. Very scratchy throat, and then quickly followed by a cough, and then rapidly began to lose my voice, and constant need to clear my throat.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event were reported; patient received an expired VARVIVAX dose.; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions or allergies were not provided.   On 26-FEB-2024, the patient was vaccinated with an expired vaccine of varicella virus vaccine live (oka/merck)(VARIVAX), 1 dose, lot number w005206, with an expiration date of 14-FEB-2024, for prophylaxis (strength, formulation, anatomical site of injeection, and route of administration were not provided) (expired product administered). No additional adverse events were reported.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to 2 year 10 month old; 3rd dose of DTaP and IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number LOT 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to 2 year 10 month old) and inappropriate schedule of vaccine administered (Verbatim: 3rd dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-MAR-2024 The reporter reported that Kinrix was administered to 2 year 10 month old patient for his 3rd dose of DTaP and IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Breast pain, Lymphadenopathy
Clinical narrative: Bell's palsy; lymph nodes in her breast; Breast is still painful; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER: 1ST BOOSTER), for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset Jan2022, outcome "not recovered"; BREAST PAIN (medically significant) with onset Jan2022, outcome "not recovered", described as "Breast is still painful"; LYMPHADENOPATHY (medically significant) with onset Jan2022, outcome "not recovered", described as "lymph nodes in her breast". The events "bell's palsy", "lymph nodes in her breast" and "breast is still painful" required physician office visit. Clinical course: Patient mentioned she had bad reaction of bell's palsy and lymph nodes after taking the 2nd Pfizer booster shot in Jan2022. Patient had a reaction to the second Pfizer booster and got bell's palsy and lymph nodes in her breast. Her doctor wants her to have an ultrasound (in addition to a mammogram because this was back in Jan2022 that she had the second booster) because her breast is still painful, but she can't afford it. Patient was wondering if Pfizer would be able to pay for that for her to check her lymph nodes. Patient also said she have seen her doctor couple of times for it since it happened, so he witnessed intermediately like it happens immediately. The bell's palsy was bad it hasn't totally gone away on her face and said there's nothing she can do for that, but she wants to have the test for her breast because they still hurt and wanted to make sure everything's okay so she's hoping that Pfizer can pay for the bill for her.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site pruritus, Injection site swelling, Pruritus, Rash
Clinical narrative: Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10037087:PRURITUS; 10037844:RASH; Narrative: 54 YO patient reported itching and swelling of right deltoid injection site after receiving her second shingles vaccine on 1/3/2023 per nursing unscheduled walk-in note on 1/24/2023. Denies wheezing, SOB, or difficulty breathing. Symptoms began about 3 days after the vaccine. PCP assessed patient skin on 1/24/23; Telederm assessed pt on 1/25/23. Patient was advised to use triamcinolone cream BID prn, avoid scratching, take a cool bath/shower without soap, and air-dry. Other Relevant HX: Other:
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus, Rash
Clinical narrative: Reported Symptoms: 10022080:INJECTION SITE ITCHING; 10037087:PRURITUS; 10037844:RASH;     Narrative:  Other Relevant HX:  Other: mild swelling mild heat itching at injection site
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain
Clinical narrative: Reported Symptoms: 10022086:INJECTION SITE PAIN; Narrative: Other Relevant HX: Other: injection site pain
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia, Pain in extremity
Clinical narrative: Reported Symptoms: 10028332:MUSCLE SORENESS; Narrative: expired vaccine. Vaccine expired 2/6/23, was administered to Patient on 2/7/23. Patient reported a little soreness in arm but no other issues per patient. Other Relevant HX: Other: little soreness in arm but no other issues per patient.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Blister, Erythema, Infusion site erythema, Infusion site vesicles
Clinical narrative: Reported Symptoms: 10048639:INFUSION SITE REDNESS; 10065465:INFUSION SITE BLISTERS; Narrative: common to have injection site redness and sore that usually goes away. Patient needed no treatment and resovled without intervention. Vaccine was added to allergy list. (Patient received 0.25ml booster dose) Other Relevant HX: Note on 8-5-2022: blister on left arm after 4th COVID vaccine- "look like a 3rd degree burn" also says right foot is swollen as well says his slippers are tight. he denies pain but says it was painful yesterday foot is red he denies SOB keeps asking for my email so he can send me photos of his arm because nobody believed him last time I advised Er and he went on tangent how facility starved his last time and billed the facility for 30K for a nights stay Note on 8-16-2022: Nurse Summary: Pt states that after second COVID vaccine (this was patient's 4th per records 3-17-21, 4-11-2021, 12-21-2021, and 8-2-2022) he had what appears to him to be a chemical burm. Pt states there is scab over the injection site. Pt states that he never sought out TX with PCP or ER. Pt states he had a reaction like this to the first COVID vaccine as well. Pt states that now his back is all knotted up like someone. "injected botox into my back and I can hardly use my right arm". Pt was advised to go to ER for assessment, Pt is refusing since this happen back on 8/2. Pt states he thinks the pregabalin may be causing his back to spasm up like that. Since Pt is refusing ER, advised note will be sent to PCP. Note: 8-17-2022: patient presented to outside ER Hospital (not for
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site scab, Muscle spasms, Musculoskeletal disorder, Peripheral swelling
Clinical narrative: Reported Symptoms: 10048639:INFUSION SITE REDNESS; 10065465:INFUSION SITE BLISTERS; Narrative: common to have injection site redness and sore that usually goes away. Patient needed no treatment and resovled without intervention. Vaccine was added to allergy list. (Patient received 0.25ml booster dose) Other Relevant HX: Note on 8-5-2022: blister on left arm after 4th COVID vaccine- "look like a 3rd degree burn" also says right foot is swollen as well says his slippers are tight. he denies pain but says it was painful yesterday foot is red he denies SOB keeps asking for my email so he can send me photos of his arm because nobody believed him last time I advised Er and he went on tangent how facility starved his last time and billed the facility for 30K for a nights stay Note on 8-16-2022: Nurse Summary: Pt states that after second COVID vaccine (this was patient's 4th per records 3-17-21, 4-11-2021, 12-21-2021, and 8-2-2022) he had what appears to him to be a chemical burm. Pt states there is scab over the injection site. Pt states that he never sought out TX with PCP or ER. Pt states he had a reaction like this to the first COVID vaccine as well. Pt states that now his back is all knotted up like someone. "injected botox into my back and I can hardly use my right arm". Pt was advised to go to ER for assessment, Pt is refusing since this happen back on 8/2. Pt states he thinks the pregabalin may be causing his back to spasm up like that. Since Pt is refusing ER, advised note will be sent to PCP. Note: 8-17-2022: patient presented to outside ER Hospital (not for
Sex: M
Vaccine: FLUX
Symptoms: Chest pain
Clinical narrative: Reported Symptoms: 10008479:CHEST PAIN; Narrative: Other Relevant HX: Other: CHEST PAIN (12/21/22@14:03:55)
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: Online report of sudden death over the weekend on Sunday March 03, 2024 involving an opera singer. Social media post from sister states victim died on Sunday in 2021 there were testing or inoculation requirements in the area according to pulbic records. A copy of VAX card after dose1 has been circulated online on 09/15/21 victim posted on social media. Data on subsequent DOSES unavailable. 10/22/21 victim asks about allergies on social media. DOSE1 date 08/17/21 LOT#939902
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Death, Oxygen saturation decreased
Clinical narrative: Copy of vax card obtained online reports indicate victim was inoculated on 03/10/21 with LOT# 1805020 By March 25, 2021 victim was hospitalized for C-19. Discharged on Saturday 04/03/21 after a 13-day stay, so it can be deducted hospitalization #1 began on Sunday 03/21/21. On 04/10/21 victim was rehospitalized with low oxygen. Victim died 8 days later on 04/18/21. It is not known how many days victim stayed during hospitalization #2 or if he died in the hospital. Estimated hospitalization 14-21 days
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient was given a  duplicate boostrix vaccine  3 weeks after original vaccine
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Rash, Urticaria
Clinical narrative: I experienced a rash/hives on the right shoulder - same shoulder as the shot, but not at the injection. Also, shingles-like symptoms - skin pain on right side of face, quick "stabs" of pain in and around right ear. The symptoms are just about gone now on 1/10/24 (I don't need any treatment), but I wanted to let you know.
Age: 31.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Underdose
Clinical narrative: Patient received hepatitis B vaccine intended for her newborn baby.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin burning sensation, Skin warm
Clinical narrative: There was about a 3 inch wide red area that is hot and patient states is burning.  Patient was advised to use ice pack, ibuprofen and benadryl on 3/9/24.  Patient returned to pharmacy on 3/10/24 and the area of redness had expanded but become much less red.  Patient said it wasn't nearly as hot but that it was a bit itchy.  Patient was advised to continue Benadryl.  She returned on 3/11/24 and the area of redness was much improved.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue
Clinical narrative: TIREDNESS AND DIZZINESS.
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: The MD gave me the order to give a pneumonia vaccine to a patient she had just seen. I gave the injection and when I went to chart on them in system I noticed that he had it prior to this about 3 months ago. I informed the provider immediately and she told me that he wouldn't have any side effects from getting the vaccine twice.
Age: 13.0
Sex: F
Vaccine: COVID19, FLUC4, TDAP
Symptoms: Eye movement disorder, Loss of consciousness, Syncope
Clinical narrative: A parent came today around 12:30p to get each of her three children flu, comirnaty and TDaP.  The fifteen year old was administered the flu and comirnaty and after receiving the TDaP, I noticed her eyes roll back in her head and she lost consciousness for a few seconds.  She became alert and I offered her candy and water.  When I came back to the room she had fainted again. At this point her mom and I lowered her to the floor. She ate the candy and drank water and gatorade. She complained of being dizzy and hot. I offered to call the paramedics but the mom refused. I checked her blood pressure and it was low, I can't remember the exact numbers. Her heart rate was also low at 63 BPM.  They spent about thirty minutes in the vaccine room. The mom requested a motorized cart so she could get her daughter to their car without walking.  I escorted them to their vehicle. I spoke with the mom this afternoon and the daughter is doing better, they have no concerns
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given Pentacel after the age of 5 years old. Pt had no adverse reactions from injection
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Cerebral artery occlusion, Incoherent, Middle cerebral artery stroke
Clinical narrative: Patient was noted to be slumped and incoherent by her brother in the evening 2/13.  Taken to ER, Right MCA stroke, s/p IR thrombectomy
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Posture abnormal, Thrombectomy
Clinical narrative: Patient was noted to be slumped and incoherent by her brother in the evening 2/13.  Taken to ER, Right MCA stroke, s/p IR thrombectomy
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Lingering shoulder pain. site after administration was red/swollen. Still experiencing pain shooting pain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac ablation, Cardiac electrophysiologic study, Inappropriate sinus tachycardia, Palpitations
Clinical narrative: My heart started racing out of no where. It happened in May of 2022, then again in May of 2023, then again in June of 2023. Currently I am being treated for Inappropriate Sinus Tachardia.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Patient was given a Hib vaccine that was reconstituted with the incorrect diluent. The vaccine was reconstituted with diluent given to the clinic for Merck products and not the diluent that comes with the Hib Vaccine. Diluent that come with the Hib vaccine is labeled (0.4% Sodium Chloride/For reconstitution of ActHib Haemophiles b Conjugate Vaccine) Diluent used is labeled  (Sterile Diluent for Merck Sharp & Dohme LLC Live Virus Vaccines/Sterile Water 0.7 mL). No adverse reaction in patient. Patient will need to be revaccinated per manufacture. Patients mother notified and scheduled for revaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Nerve injury, Neuropathy peripheral, Rectal spasm
Clinical narrative: Low grade hypersensitivity reaction between 18-30 hours after vaccination. Involve areas of nerve damage, neuropathy in toes had burning pain in balls of feet, rectal nerve damage area experienced rectal spasms. My doctor recommended file a report, it is not an allergic reaction.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head, Condition aggravated, Cyanopsia, Echocardiogram
Clinical narrative: PFIZER #1 2/10/2021 PFIZER #2 3/3/2021 PFIZER #39/28/2021.  HAD LOCAL REACTIONS AFTER EACH INJECTION.  NOVEMBER 2023 HAD STROKE WITH DIFFICULTY WITH VISION AND ISOLATED TO THE OCULAR CORTEX.  HAS REMAINING BLUE TINGE BILATERALLY TO HIS EYE SIGHT.  WORSENED HTN AFTER VACCINATION.  ALSO HAS POST-EXERTIONAL FATIGUE AND EXERCISE INTOLERANCE.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Exercise tolerance decreased, Fatigue, Hypertension, Laboratory test
Clinical narrative: PFIZER #1 2/10/2021 PFIZER #2 3/3/2021 PFIZER #39/28/2021.  HAD LOCAL REACTIONS AFTER EACH INJECTION.  NOVEMBER 2023 HAD STROKE WITH DIFFICULTY WITH VISION AND ISOLATED TO THE OCULAR CORTEX.  HAS REMAINING BLUE TINGE BILATERALLY TO HIS EYE SIGHT.  WORSENED HTN AFTER VACCINATION.  ALSO HAS POST-EXERTIONAL FATIGUE AND EXERCISE INTOLERANCE.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Local reaction, Magnetic resonance imaging head, Visual impairment
Clinical narrative: PFIZER #1 2/10/2021 PFIZER #2 3/3/2021 PFIZER #39/28/2021.  HAD LOCAL REACTIONS AFTER EACH INJECTION.  NOVEMBER 2023 HAD STROKE WITH DIFFICULTY WITH VISION AND ISOLATED TO THE OCULAR CORTEX.  HAS REMAINING BLUE TINGE BILATERALLY TO HIS EYE SIGHT.  WORSENED HTN AFTER VACCINATION.  ALSO HAS POST-EXERTIONAL FATIGUE AND EXERCISE INTOLERANCE.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Local reaction, Pruritus, Rash, Rash pruritic
Clinical narrative: PATIENT RECEIVED 1ST SHINGLES SHOT ON 1/23/23. HAD A LOCAL REACTION ON LEFT ARM FOLLOWING THE SHOT (WITHIN A FEW DAYS). THEN ABOUT A WEEK LATER PATIENT NOTICED A RASH ON HER SCALP. 2ND SHINGRIX VACCINE WAS GIVEN ON 5/1/23. PATIENT STATES SHE DOESN'T REMEMBER LOCAL REACTION ON ARM, BUT ABOUT A WEEK LATER PATIENT STARTED HAVING ANOTHER RASH ON HER HEAD (INTENSE ITCHING, SCABS, FELT LIKE IT WAS ON FIRE). MID AUGUST, PATIENT SAW DERMATOLOGIST. THEY TRIED KETOCONAZOLE SHAMPOO (EVERY OTHER DAY), MOMETASONE 0.1% SOLN (ONCE DAILY 2-3 DAYS PER WEEK AS NEEDED). PATIENT STATES RASH WORSENED TO HER FACE. THEN SHE WAS PUT ON METRONIDAZOLE 0.75% CREAM. PATIENT HAS ALSO BEEN TRYING SILVER COLLOIDAL GEL ON SCALP & FACE. THAT SEEMS TO BE HELPING THE MOST. PATIENT STILL HAS DISCOLORATION ON FOREHEAD, AROUND EARS AND SCALP (SHE CALLS THEM POLKA DOTS). WHEN PATIENT SAW HER DERMATOLOGIST AGAIN IN FEB 2024, THE PROVIDER STATED HE THOUGHT IT COULD BE LONG-TERM SHINGLES RASH. IT FLARES UP AND THEN RESOLVES, SO IT IS HARD FOR THEM TO GET A SWAB TO PROPERLY DIAGNOSE, PER PATIENT.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Skin burning sensation, Skin discolouration
Clinical narrative: PATIENT RECEIVED 1ST SHINGLES SHOT ON 1/23/23. HAD A LOCAL REACTION ON LEFT ARM FOLLOWING THE SHOT (WITHIN A FEW DAYS). THEN ABOUT A WEEK LATER PATIENT NOTICED A RASH ON HER SCALP. 2ND SHINGRIX VACCINE WAS GIVEN ON 5/1/23. PATIENT STATES SHE DOESN'T REMEMBER LOCAL REACTION ON ARM, BUT ABOUT A WEEK LATER PATIENT STARTED HAVING ANOTHER RASH ON HER HEAD (INTENSE ITCHING, SCABS, FELT LIKE IT WAS ON FIRE). MID AUGUST, PATIENT SAW DERMATOLOGIST. THEY TRIED KETOCONAZOLE SHAMPOO (EVERY OTHER DAY), MOMETASONE 0.1% SOLN (ONCE DAILY 2-3 DAYS PER WEEK AS NEEDED). PATIENT STATES RASH WORSENED TO HER FACE. THEN SHE WAS PUT ON METRONIDAZOLE 0.75% CREAM. PATIENT HAS ALSO BEEN TRYING SILVER COLLOIDAL GEL ON SCALP & FACE. THAT SEEMS TO BE HELPING THE MOST. PATIENT STILL HAS DISCOLORATION ON FOREHEAD, AROUND EARS AND SCALP (SHE CALLS THEM POLKA DOTS). WHEN PATIENT SAW HER DERMATOLOGIST AGAIN IN FEB 2024, THE PROVIDER STATED HE THOUGHT IT COULD BE LONG-TERM SHINGLES RASH. IT FLARES UP AND THEN RESOLVES, SO IT IS HARD FOR THEM TO GET A SWAB TO PROPERLY DIAGNOSE, PER PATIENT.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes simplex test, Pruritus, Varicella virus test
Clinical narrative: one week after vaccination had one vesicle back area. felt itchy, no fever or chills. no cough, no uri symptoms.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness, swelling and itching  from deltoid to elbow
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Adult dose of Hepatitis A was given to 13 year old. No adverse outcome known.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza virus test, Pyrexia, SARS-CoV-2 test, Syncope
Clinical narrative: fever, chills,shivering, fainted
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 breakthrough Infection
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered inappropriately based on patient age and guidelines
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Myalgia
Clinical narrative: Burning sensation "shot down real quick and then shot back up and expand and went out into the back part of my body". Mainly in the muscle areas of the left arm according to patient. He could also feel it in his collar bone. After 10 to 15 minutes (around 11:20am) patient said it was better as long as he didn't focus on the sensation.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC20, VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash appeared on right upper thigh
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received 6months - 11 years Moderna vaccine instead of 12+ of Moderna
Age: 8.0
Sex: F
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Facial discomfort, Hypersensitivity, Periorbital oedema, Periorbital swelling
Clinical narrative: The patient and her guardian reported to the clinic for an appointment on 03/15/2024. At this appointment the guardian reported that the patient had facial swelling the day after the previous immunization appointment (02/16/2024). The patient was seen on 02/17/2024 at Medical Center and the encounter report states that the patient had eye swelling; "8-year-old female complains of swelling around both eyes onset early afternoon after taking ibuprofen due to some mild discomfort related to it. Denies difficulty swallowing or breathing. No other known exposures" and "periorbital edema bilaterally after taking ibuprofen early this afternoon. Had 4 vaccinations yesterday at Doctor's office. Unsure if related to vaccines versus ibuprofen, but started soon after ibuprofen. Mild periorbital edema on exam without airway compromise. No intraoral edema or lesions. No rash. Given oral Benadryl and observed in ER for a while. Only steady improvement. No indication for further workup or hospitalization." and Clinical Impressions "Allergic reaction, initial encounter".
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Coma, Computerised tomogram, Electrocardiogram, Electroencephalogram, Encephalopathy
Clinical narrative: Whole body hives then the next day I went into a coma for 3 days/ intubation from encephalopathy
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Endotracheal intubation, Magnetic resonance imaging, Urticaria
Clinical narrative: Whole body hives then the next day I went into a coma for 3 days/ intubation from encephalopathy
Age: 57.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Pharyngeal swelling
Clinical narrative: SOB and felt like throat was swelling 10 minutes after administration.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Brain injury, Cerebrovascular accident, Device occlusion
Clinical narrative: STROKE blackout FALL, 7/2021, all other illnesses have presented and have continued
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Disability, Fall, Hepatic cirrhosis, Hernia
Clinical narrative: STROKE blackout FALL, 7/2021, all other illnesses have presented and have continued
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Male reproductive tract disorder, Neoplasm malignant, Post-traumatic stress disorder, Restless legs syndrome
Clinical narrative: STROKE blackout FALL, 7/2021, all other illnesses have presented and have continued
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rib fracture, Rotator cuff syndrome, Spinal fracture, Spinal fusion surgery, Tinnitus
Clinical narrative: STROKE blackout FALL, 7/2021, all other illnesses have presented and have continued
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: STROKE blackout FALL, 7/2021, all other illnesses have presented and have continued
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Developed ringing in both ears that has progressively gotten louder as time goes by, especially after receiving the booster..
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: Wrong product administered
Clinical narrative: Wrong Vaccine was given, instead of Moderna Spikevax 12+ covid vaccine, patient was given Pneumonia Vaccine.Revaccinate all 3 staff members and provide updated immunization records to all 3 staff members after revaccination
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix vaccine was not reconstituted before given. Only adjuvant was given.
Age: 39.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Extra dose administered
Clinical narrative: Client requested a flu vaccine.  Nurse assessed record and saw previous flu given in 2023 and thought it was last season.  Administered Flu vaccine then realized previous dose was given this season.
Age: 63.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Contusion, Dizziness, Lethargy, Peripheral swelling
Clinical narrative: Patient had dizziness right after receiving the vaccination.  She also experienced lethargy for over a week. She also had a raised bump on arm that had some swelling and bruising.
Age: 0.5
Sex: M
Vaccine: COVID19-2, DTAPHEPBIP, FLUA4, PNC13, RV1
Symptoms: Infant irritability, Pyrexia
Clinical narrative: fever of 100.9, fussy
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Myalgia
Clinical narrative: Patient feels her arm muscle has been sore since her vaccination
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: CSF test normal, Headache, Lymphocytosis, Neck pain, Procedural failure
Clinical narrative: On March 4, 2024, at approximately 3:00 PM, she started having headache with vomiting. She continued to have headache until Saturday and her neck was sore also. She vomited the second time on Saturday. An LP was attempted and not successful. She was then transferred to another hospital. She had a successful LP on Sunday that was negative for meningitis. She was discharged yesterday and reportedly told they were not sure about the cause of her headache, but she was given antiviral medication only while admitted. She rates her headache at 20% now of what it was.        Her lab reports available online were reviewed using her phone and the initial WBC on 03/05/2024 was a little over 14K with another checked on 03/10/24 at 12K with lymphocytosis and another yesterday with normal WBC. CSF testing was normal.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: On March 4, 2024, at approximately 3:00 PM, she started having headache with vomiting. She continued to have headache until Saturday and her neck was sore also. She vomited the second time on Saturday. An LP was attempted and not successful. She was then transferred to another hospital. She had a successful LP on Sunday that was negative for meningitis. She was discharged yesterday and reportedly told they were not sure about the cause of her headache, but she was given antiviral medication only while admitted. She rates her headache at 20% now of what it was.        Her lab reports available online were reviewed using her phone and the initial WBC on 03/05/2024 was a little over 14K with another checked on 03/10/24 at 12K with lymphocytosis and another yesterday with normal WBC. CSF testing was normal.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: 36 weeks pregnant when vaccine was administered. Due date was 14 Sep 2023. Baby was delivered early. Baby weighed 6lbs 12 oz, length was 18.75 inches.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Patient came in today for evaluation of vomiting, diarrhea and cough for the past 3 days.  Patient's 4-year-old vaccinations were ordered by MD, vaccines were administered per MD order by covering LVN.  Per chart review these vaccines had already been given on 8/10/2023.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Administration Error: Upon verifying with MA, she informed me that she administered Pfizer ages 5-11, went to vaccine vault and pulled out box which indicated Pfizer ages 5-12. MA confused the vaccine age and administered it to the patient who was 12 years old during time of visit.  Patients guardian was contacted to discuss vaccine error and was advised to bring patient to the clinic for correct vaccine administration.  Upon speaking to the patient's guardian, no signs and symptoms occurred after the vaccine administration.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Unevaluable event
Clinical narrative: Pt was given correct vaccine but information was entered incorrectly as expired
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: Patient experienced dizziness during the vaccine process. Mother and guardian stated that she is an extremely nervous person and always experiences dizziness when nervous.
Age: 56.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Off label use
Clinical narrative: the patient was administered the GARDASIL 9 vaccine off-label; No additional AE; This spontaneous report was received from Other Health Professional and refers to a 56-years-old female patient (currently 58 years old). Her medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date (when she was 56-years-old), the patient was vaccinated off-label with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date and route of administration were not reported). It was unknown if the patient received second and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. No additional adverse events.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from Nurse Practitioner and refers to a 6-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccie underwent multiple excursion from 19-OCT-2023 to 22-JAN-2024 for 9 hour 27 minutes in the -14 to -10 degree Celsius range(Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from Nurse Practitioner and refers to a 5-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccie underwent multiple excursion from 19-OCT-2023 to 22-JAN-2024 for 9 hour 27 minutes in the -14 to -10 degree Celsius range(Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from Nurse Practitioner and refers to a 9-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccie underwent multiple excursion from 19-OCT-2023 to 22-JAN-2024 for 9 hour 27 minutes in the -14 to -10 degree Celsius range(Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.