chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: varicella zoster antibodies IGg test negative after Shingrix two doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 21-JAN-2022, the patient received the 2nd dose of Shingrix. On 05-OCT-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced therapy non-responder (Verbatim: varicella zoster antibodies IGg test negative after Shingrix two doses). The outcome of the therapy non-responder was unknown.   Additional Information: GSK Receipt Date: 04-APR-2024 The reporter called from doctor's office and reported that the patient with two doses of Shingrix whose provider ordered varicella zoster antibodies Igg and they came back negative, which led to therapy non-responder. Reporter asked was there something that routinely done provided by the Shingrix vaccines, reporter know that some studies used the varicella anti glycoprotein E antibodies. The reporter consented to follow-up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient was past the 6 month window in receiving the third dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: a patient was past the 6 month window in receiving the third dose of Twinrix). The outcome of the incomplete course of vaccination was 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: 04-APR-2024 Healthcare professional (HCP) reported a patient was past the 6 month window in receiving the third dose of Twinrix. The Healthcare professional (HCP) did not want to provide any patient information. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 3rd dose of Twinrix vaccine, which led to incomplete course of vaccination.
Age: 10.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient over 7 years received Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2227K, expiry date 17-JAN-2026) for prophylaxis.   On 05-APR-2024, the patient received the 1st dose of Pediarix. On 05-APR-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient over 7 years received Pediarix). The outcome of the inappropriate age at vaccine administration was 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: 05-APR-2024 The medical Assistant reported that the patient over 7 years received Pediarix as a first Dtap, IPV and Hep B dose on their vaccination history, which led to inappropriate age at vaccine administration. The patient did not have any Dtap or IPV record this was why they decided to administer a combo vaccine. The reporter consented to follow up. This case has been linked to the case US2024043650 and US2024043649 reported by the same reporter.; Sender's Comments:  US-GSK-US2024043649:Same reporter / different patient US-GSK-US2024043650:same reporter/ different patient
Age: 55.0
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave the third dose 9 days early from the 6 months; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date) and Twinrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: gave the third dose 9 days early from the 6 months). The outcome of the drug dose administration interval too short was 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: 09-APR-2024 The reporter reported that they gave first dose of Twinrix to a patient one month later gave the second dose and third dose nine days early from the six months. The patient received 3rd dose of Twinrix earlier than recommended interval, which led to shortening of vaccination schedule.  The reporter did not consent to follow up. Medical assistant did not consent to add her contact into medical database. No email nor phone was provided. Medical information agent did not ask permission for pharmacovigilant follow-up since health care professional had to check a Patient.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEFT LEG; This spontaneous report received from an attorney via a company representative: Documents were received in the form of claim document and medical records and concerned a patient of unknown race and ethnicity, unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAR-2021 for covid-19 prophylaxis (dose series 1). No concomitant medications were reported. On 21-DEC-2023, the patient experienced blood clot in left leg. On 25-JAN-2024, 06-FEB-2024, 15-FEB-2024 and 29-FEB-2024, the patient had to undergo a surgical procedure to address the blood clot issue and was scheduled to undergo two more procedures over the next month. The patient never had a vascular issue previously.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in left leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; Medical assessment comment not required as per standard procedure since it is a legal case.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ACTHIB was given 1 to 3 days after the expiration date with no adverse event; Initial information received on 05-Apr-2024 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves an unknown age/gender patient who was administered HIB (PRP/T) Vaccine [ActHIB] 1 to 3 days after the expiration date 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 unknown dose of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) 1 to 3 days after the expiration date with no adverse event (expired product administered) (latency: same day) (lot UJ863AA) (expiry: 25-Mar-2024) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  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: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Blood homocysteine, Blood pressure fluctuation, Blood thyroid stimulating hormone, Cardiac monitoring
Clinical narrative: 6-8 hours after shot lost control in right side of body along with many other symptoms including spasms, huge spikes in BP and HR,  Tingle like sensation would shoot out from my nerves and cause lots of problems. Progressed into muscle atrophy and have indents of muscle kidding from my body now. Can?t walk upstairs. Devastated my entire life and re learning how to try to exist with all these health issues and stipulations in very difficult. Drs all see my very high creatine kinase and the physical evidence but unfortunately can?t figure out exactly what?s going on I?m told. Many visits.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram, Echocardiogram, Electrocardiogram, Electrophoresis
Clinical narrative: 6-8 hours after shot lost control in right side of body along with many other symptoms including spasms, huge spikes in BP and HR,  Tingle like sensation would shoot out from my nerves and cause lots of problems. Progressed into muscle atrophy and have indents of muscle kidding from my body now. Can?t walk upstairs. Devastated my entire life and re learning how to try to exist with all these health issues and stipulations in very difficult. Drs all see my very high creatine kinase and the physical evidence but unfortunately can?t figure out exactly what?s going on I?m told. Many visits.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Heart rate irregular, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test
Clinical narrative: 6-8 hours after shot lost control in right side of body along with many other symptoms including spasms, huge spikes in BP and HR,  Tingle like sensation would shoot out from my nerves and cause lots of problems. Progressed into muscle atrophy and have indents of muscle kidding from my body now. Can?t walk upstairs. Devastated my entire life and re learning how to try to exist with all these health issues and stipulations in very difficult. Drs all see my very high creatine kinase and the physical evidence but unfortunately can?t figure out exactly what?s going on I?m told. Many visits.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Muscle atrophy, Muscle spasms, Nerve conduction studies, Paraesthesia
Clinical narrative: 6-8 hours after shot lost control in right side of body along with many other symptoms including spasms, huge spikes in BP and HR,  Tingle like sensation would shoot out from my nerves and cause lots of problems. Progressed into muscle atrophy and have indents of muscle kidding from my body now. Can?t walk upstairs. Devastated my entire life and re learning how to try to exist with all these health issues and stipulations in very difficult. Drs all see my very high creatine kinase and the physical evidence but unfortunately can?t figure out exactly what?s going on I?m told. Many visits.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Troponin I
Clinical narrative: 6-8 hours after shot lost control in right side of body along with many other symptoms including spasms, huge spikes in BP and HR,  Tingle like sensation would shoot out from my nerves and cause lots of problems. Progressed into muscle atrophy and have indents of muscle kidding from my body now. Can?t walk upstairs. Devastated my entire life and re learning how to try to exist with all these health issues and stipulations in very difficult. Drs all see my very high creatine kinase and the physical evidence but unfortunately can?t figure out exactly what?s going on I?m told. Many visits.
Age: 54.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Blister, Gingival pain, Headache, Oral herpes, Pain
Clinical narrative: Headaches, body aches, feverish, Left side face -cold sore blisters on lip, painful facial bisters, swollen cheek, sore gums on left side
Age: 54.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pyrexia, Swelling face
Clinical narrative: Headaches, body aches, feverish, Left side face -cold sore blisters on lip, painful facial bisters, swollen cheek, sore gums on left side
Age: 53.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL, VARZOS
Symptoms: Injection site swelling, Rash, Skin mass
Clinical narrative: Swelling of upper left arm around area of subcutaneous injection, painful rash, nodules under skin
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 04-APR-2024 A reporter reported that the administration of Shingrix after a series had already been administered and the patient had a case of shingles.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired dose of Daptacel was inadvertently administered with no reported adverse event; Initial information received on 09-Apr-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 15-month-old male patient and an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was inadvertently administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 08-Apr-2024, the patient received a 0.5 ml dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (strength: unknown) (lot: C5980AB, Expiry date: 06-Apr-2024) via intramuscular route in the left vastus lateralis for Immunization and an expired dose of daptacel was inadvertently administered 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: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: nurse stated that the vaccine was given, and it was expired a couple days ago with no reported adverse event; Initial information received on 10-Apr-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 months old female patient who was administered expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] a couple days ago with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Apr-2024, the patient received 0.5 ml of expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (Suspension for injection) a couple days ago with no reported adverse event (expired product administered) (Latency: same day) (lot UJ865AA) (expiry: unknown) (strength: standard) (frequency: once) via intramuscular route in right thigh for Prophylactic Vaccination (Immunisation).  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. 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: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Aldolase, Antinuclear antibody, Asthenia, Blood creatine phosphokinase, Blood uric acid
Clinical narrative: I woke up at 4 in the morning and my arms, legs and neck were weak and hurt. I went to dr 10 days later and got some prednisone. I doctored for weeks until they sent me to a Rheumatologist. I have been diagnosed with PMR (polymyalgia rheumatica)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Differential white blood cell count, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: I woke up at 4 in the morning and my arms, legs and neck were weak and hurt. I went to dr 10 days later and got some prednisone. I doctored for weeks until they sent me to a Rheumatologist. I have been diagnosed with PMR (polymyalgia rheumatica)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Neck pain, Pain in extremity, Polymyalgia rheumatica, Red blood cell sedimentation rate
Clinical narrative: I woke up at 4 in the morning and my arms, legs and neck were weak and hurt. I went to dr 10 days later and got some prednisone. I doctored for weeks until they sent me to a Rheumatologist. I have been diagnosed with PMR (polymyalgia rheumatica)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rheumatoid factor, Urine analysis
Clinical narrative: I woke up at 4 in the morning and my arms, legs and neck were weak and hurt. I went to dr 10 days later and got some prednisone. I doctored for weeks until they sent me to a Rheumatologist. I have been diagnosed with PMR (polymyalgia rheumatica)
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diplegia, Gait disturbance, Pyrexia
Clinical narrative: Fever  Chills   Sudden paralysis of legs .   General overall weakness lasted for 5 days.  Patient did not seek immediate treatment.  Patient is still unable to walk without assistance.  Unable to get correct diagnosis of condition.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Pfizer BioNTech Covid 19 5-11 year old vaccine at the age of 12. No reaction occured. Patient also has not had COVID since being vaccinated.
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: Patient was given Tdap vaccine in clinic setting on 4/5/2024. Upon injecting the Tdap vaccine the vaccine solution poured out around the hub of the needle instead of going into the patient's muscle. NDC: 58160-842-43. Lot ET475. Exp date 5/8/2026. 25 gauge x 1 inch needle. Physician did approve of giving patient another dap vaccine at that time. This is the 2nd occurrence of this fluid leaking issue with Tdap vaccines at our facility.
Sex: F
Vaccine: COVID19
Symptoms: Discouragement, Energy increased, Influenza, Loss of personal independence in daily activities, Pain
Clinical narrative: At the end of December I got really sick with the flu. I went to teh emergency room and was hospitalized in the hospital for four nights. The COIVD booster gave me Rheumatoid Arthritis. I have been taking half doses, so that I do not run out of medication. In general, health is good; Limited a little in moderate activites; Moderate interference of pain with normal work; Felt calm and peaceful most of the time; Had a lot of energy some of the time; Felt downhearted and blue some of the time; Physical or emotional health interferes with social activities a little of the time; Accomplished less work than would like due to physical health;
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: At the end of December I got really sick with the flu. I went to teh emergency room and was hospitalized in the hospital for four nights. The COIVD booster gave me Rheumatoid Arthritis. I have been taking half doses, so that I do not run out of medication. In general, health is good; Limited a little in moderate activites; Moderate interference of pain with normal work; Felt calm and peaceful most of the time; Had a lot of energy some of the time; Felt downhearted and blue some of the time; Physical or emotional health interferes with social activities a little of the time; Accomplished less work than would like due to physical health;
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site warmth
Clinical narrative: Redness, hot to the touch and itchiness on the site of vaccination.
Age: 73.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Developed rash and hives on upper body and arms. Photo is available and can be provided on request.  Went to ER at Hospital.  Was given IV treatment of steroid and antihistamine. Rash and hives went away after about an hour. Continued to take prescribed oral medication for two days thereafter.
Age: 73.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Developed rash and hives on upper body and arms. Photo is available and can be provided on request.  Went to ER at Hospital.  Was given IV treatment of steroid and antihistamine. Rash and hives went away after about an hour. Continued to take prescribed oral medication for two days thereafter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: On 3/26/24 it was brought to the attention that a patient was incorrectly immunized with Quadracel on March 29,2023 for the 3rd dose of DTaP and 3rd dose of Polio. The patient was 4 years, 8 months old at the time. The patient returned on 3/26/24 and the error was noticed by another nurse when reviewing  patient's immunization record to see what was due. The error was reported to Immunization program nurse. Per guidelines, the dose is considered valid because the minimum interval was met, however, the dose is considered an administration error as Quadracel is licensed and recommended for use as the 5th dose of DTaP and the 4th or 5th dose of Polio and was utilized in this situation as the third dose of both DTaP and Polio. Patient's mother reported patient had no reaction to this vaccination or any previous vaccinations.
Age: 29.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose given to soon.  1st dose given 6/27/2022 and 2nd dose given 8/9/2022
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Left upper arm is swollen, hot to touch, itchy and hurts. Pt received HPV vaccine on 4/11  Red injection site since HPV vaccine 3 days ago. Itchy, warm and painful. Not improving. Taking Tylenol, cool compresses. DX cellulitis secondary to HPV vaccine. Keflex BID prescribed
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site warmth
Clinical narrative: Left upper arm is swollen, hot to touch, itchy and hurts. Pt received HPV vaccine on 4/11  Red injection site since HPV vaccine 3 days ago. Itchy, warm and painful. Not improving. Taking Tylenol, cool compresses. DX cellulitis secondary to HPV vaccine. Keflex BID prescribed
Age: 61.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site, redness, hot to the touch, pain at injection site. Everything started at the same time.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This vaccine was given 1.5 years earlier than the CDC recommended timeline based on her last pneumonia vaccine (Pneumovax 23 on 9/30/2020)
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Lingering deep muscle pain that does not go away. Pain is moderate to severe depending on activity, for example- when L arm is at rest for long periods of time, when sleeping, upon awakening L arm is very stiff, achy and difficult to get moving without shooting pain from upper arm. This has been going on since booster vaccination and isn't lessening or going away. I use OTC Ibuprofen for pain management and range of motion to keep it from being stiff/sore. The pain is at it's worst when arm hasn't been in use for a while, as I described when sleeping, and improves once I use it for normal activities but always there. Cold and damp also seem to make it ache more.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Fatigue, Neck pain
Clinical narrative: After receiving the second dose of Shingrix, the following day I experienced fatigue and joint pain. The joint pain included knees, ankles, and large toes of both legs, back, neck, left elbow, and right wrist. As the day progress, the fatigue subsided. The joint pain took a couple of days before improving. There have been obvious, continued issues with the joint pain, though, and has spiked nine days after the shot. The greatest pain is with the left leg; knee, ankle, and big toe. There is also pain with the back and neck (whereby it seems to have really exacerbated my neck injury).  It is the tenth day, I have just taken some ibuprofen, and realized I need to submit this form.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Client had appointment 4/11/24 at our clinic to receive immunizations. Per parent, injection site on right arm started turning red and swollen on 4/12/24 Per parent client was taken to urgent care on 4/12/24 in the evening and was instructed to use benadryl, cool compress, monitor size of area that was red, and to follow up with PCP. Per parent, client missed school 4/12/24 but returned to school today 4/15/24. Parent took pictures of injection site every day since incident and per parent swelling and redness had gone down significantly.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Fatigue, Incorrect dose administered, Injection site erythema
Clinical narrative: Child give 2nd dose of Hep A 4/12/24.  Adult dose was administered but this is a 19m old child.  Slight redness at injection site noted today 4/15/24. Child was more tired then usual over the weekend 4/13/24 - 4/14/24.  Parent will monitor for localized reaction at injection site. No additional treatment required or anticipated.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: EXPIRED VACCINE GIVEN. NO ADVERSE REACTIONS. EXP DATE 4/11/24
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Culture wound, Herpes zoster disseminated
Clinical narrative: Disseminated herpes zoster.  Plan A) Stop all ATB and steroids B) Start PO Valcyclovir 1 gm q 8 hs C) May need IV Acyclovir D) Wound cx to r.o bacterial super infection E) contact isolation F) Reassess
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Infusion, Laboratory test abnormal, Rash pruritic
Clinical narrative: Disseminated herpes zoster.  Plan A) Stop all ATB and steroids B) Start PO Valcyclovir 1 gm q 8 hs C) May need IV Acyclovir D) Wound cx to r.o bacterial super infection E) contact isolation F) Reassess
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 3 days after my 1st Shingrix vaccination, symptoms progressed from low-grade, half-degree fever, flu-like body aches, and injection-arm soreness to a 3-inch round redness around the injection site and itchiness at the injection site. Two weeks later the round redness was still visible and the site still itchy. Also a small, slightly raised red patch on side.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 3 days after my 1st Shingrix vaccination, symptoms progressed from low-grade, half-degree fever, flu-like body aches, and injection-arm soreness to a 3-inch round redness around the injection site and itchiness at the injection site. Two weeks later the round redness was still visible and the site still itchy. Also a small, slightly raised red patch on side.
Age: 69.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient came to the pharmacy on 4/15/24 to report this adverse event with her Covid vaccine. Patient was given the vaccine on 2/6/24, her left arm was sore afterwards as expected but the pain never went away and can still point to the injection site from pain source.  She wanted to give the injection site a couple of weeks to resolve before becoming too concerned.  She was so consumed with the left arm being sore she did not notice at what point her left leg began to hurt. She states the left leg radiates pain from  groin to top of left knee.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC20
Symptoms: Urticaria
Clinical narrative: 8 month male receiving 6month vaccines at Health (Medical Plaza @ 2nd Floor). He received Pentacel, Energix B and Prevnar 20 in left Vastus lateralis at 11:15 4/12/24. He experienced hives and urticaria. No Short of breath, drooling, closing of throat. Patient was sent to another floor to be assessed by doctor and triaged by nurse, RN. Pt was awake, and in no apparent distress. Vital signs were obtained and stable. Patient  was weighed and given Diphenhydramine Elixir 10mg / 4ml for Urticaria Treatment. He was then monitored for 1 hour after reaction. Patient will be followed up by his primary physician on 4/15/24.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Fatigue, Pyrexia, Rash
Clinical narrative: Fever, tiredness, and rash
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Ocular hyperaemia, Ophthalmic herpes zoster
Clinical narrative: PATIENT HAD  SHIGRIX  (FIRST ROUND) VACCINE ADMINISTERED ON APRIL 1ST, 2024 . BY FRIDAY PATIENT WOKE UP WITH SEVERE LEFT EYE PAIN. WENT TO HOSPITAL FOR 2 VISITS. THEY CONFIRM THAT THE PAIN WAS DUE TO THE SHINGLES OUTBREAK IN HIS EYE.  HE REPORTED THIS TODAY TO OUR FACILITY , APRIL 15TH. HE STATES THE EYE PAIN IS HORRIBLE. HIS EYE IS STILL VERY RED
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Computerised tomogram head abnormal, Death, Haemorrhage intracranial, Hypertension
Clinical narrative: Resident with altered mental status , hypertensive (161/78) sent 911 to MC expired at MC 04/10/2024 at 1801.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Mental status changes
Clinical narrative: Resident with altered mental status , hypertensive (161/78) sent 911 to MC expired at MC 04/10/2024 at 1801.
Age: 26.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Gastrointestinal disorder, Guillain-Barre syndrome, Nausea, Vomiting
Clinical narrative: Patient presented with GI symptoms first with nausea and vomiting and continued to get worse, then later on she was diagnosed with Guilian Barre.
Age: 26.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Patient presented with GI symptoms first with nausea and vomiting and continued to get worse, then later on she was diagnosed with Guilian Barre.
Age: 26.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Immunoglobulin therapy, Insurance issue, Loss of personal independence in daily activities, Lumbar puncture abnormal, Muscle spasms
Clinical narrative: Patient presented with GI symptoms first with nausea and vomiting and continued to get worse, then later on she was diagnosed with Guilian Barre.
Age: 26.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Nausea, Pain, Paralysis, Vomiting
Clinical narrative: Patient presented with GI symptoms first with nausea and vomiting and continued to get worse, then later on she was diagnosed with Guilian Barre.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: Gait inability, Musculoskeletal disorder, Myelitis transverse
Clinical narrative: Parent reported transverse myelitis.   Unable to walk or use right arm developed 6 weeks after immunization
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: Chest X-ray, Clonus, Computerised tomogram head normal, Computerised tomogram neck normal, Dyskinesia
Clinical narrative: Parent reported transverse myelitis.   Unable to walk or use right arm developed 6 weeks after immunization
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: Dysstasia, Fall, Foot deformity, Gait disturbance, Gait inability
Clinical narrative: Parent reported transverse myelitis.   Unable to walk or use right arm developed 6 weeks after immunization
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: General physical health deterioration, Hemiparesis, Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: Parent reported transverse myelitis.   Unable to walk or use right arm developed 6 weeks after immunization
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: Musculoskeletal disorder, Myelitis transverse, Posture abnormal, Product use issue, Tremor
Clinical narrative: Parent reported transverse myelitis.   Unable to walk or use right arm developed 6 weeks after immunization
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, HPV9, MNQ, UNK, UNK
Symptoms: Walking aid user, X-ray limb normal, X-ray of pelvis and hip normal
Clinical narrative: Parent reported transverse myelitis.   Unable to walk or use right arm developed 6 weeks after immunization
Age: 0.42
Sex: M
Vaccine: UNK
Symptoms: Autism spectrum disorder, Condition aggravated, Electroencephalogram, Infantile spasms, Mental disorder
Clinical narrative: Infantile spasms , treatment ACTH for 1 month, Out come extremely Mentally delayed,  Non Verbal,  Autism level 2
Age: 0.42
Sex: M
Vaccine: UNK
Symptoms: Speech disorder
Clinical narrative: Infantile spasms , treatment ACTH for 1 month, Out come extremely Mentally delayed,  Non Verbal,  Autism level 2
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Aphasia, Attention deficit hyperactivity disorder, Autism spectrum disorder, Borderline personality disorder, Eyelid ptosis
Clinical narrative: 4/29/2006 (10 days later) experienced a non-febrile seizure (went limp, couldn't keep eyes open or talk). Went to ER where we were visiting family. Conducted a range of tests that showed no conclusive causes. Over several hours she gradually returned to normal without any other treatment. Followed up with her pediatrician when we got back home. She reviewed documents from the ER and told us it was likely a one-off but to watch to see if it happened again. In spring 2021, she was diagnosed with ADHD by psychiatrist. In 2022, she was diagnosed with mild autism by psychiatrist. Later in 2023, she was diagnosed with Borderline Personality Disorder and possible Bipolar while in residential treatment.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Hypotonia, Laboratory test, Seizure
Clinical narrative: 4/29/2006 (10 days later) experienced a non-febrile seizure (went limp, couldn't keep eyes open or talk). Went to ER where we were visiting family. Conducted a range of tests that showed no conclusive causes. Over several hours she gradually returned to normal without any other treatment. Followed up with her pediatrician when we got back home. She reviewed documents from the ER and told us it was likely a one-off but to watch to see if it happened again. In spring 2021, she was diagnosed with ADHD by psychiatrist. In 2022, she was diagnosed with mild autism by psychiatrist. Later in 2023, she was diagnosed with Borderline Personality Disorder and possible Bipolar while in residential treatment.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain
Clinical narrative: A few days after her injection she started having intense pain in her left shoulder. She has decreased RO and the pain is constant. Wearing clothes is painful in her left upper arm.  She states she never had a fever, the injection site was not red nor was it edematous. It is nearly 3 weeks later. She doesn't have insurance so she delayed coming into the doctor thinking it would go away on its own.  This came from private stock vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash slightly below injection site appeared over weekend
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: No Adverse Reaction
Age: 9.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Contraindication to vaccination, Photosensitivity reaction, Rash, Rhinorrhoea
Clinical narrative: Pt. was vaccinated 4/3/24 with MMR and Tdap. The guardian (grandmother) only wanted MMR and Tdap vaccines. She stated that patient had dupixent 300mg injection for atopic dermatitis 3 weeks prior. I consulted with our NP and she stated to vaccinate the patient. The grandmother came in on 4/15/24 at 8am to tell me that her grandson had diffused rashes with runny nose and photosensitivity when he woke up this morning on 4/15/24. The NP instructed her to go to pediatric urgent care for ruling out post vaccination measles.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia, Rash, Rash pruritic
Clinical narrative: Pt. experienced fever, chills, myalgias within 24 hours. Then about 72 hours after the vaccine, she started with a blistery pruritic rash on her right abdomen that spread to her right flank.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Pt. experienced fever, chills, myalgias within 24 hours. Then about 72 hours after the vaccine, she started with a blistery pruritic rash on her right abdomen that spread to her right flank.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: injection site has been very itchy and started to get red and warm and slightly tender to touch
Age: 1.83
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Pt came in and needed vaccines that had private insurance. Pt was given Hep B and when the MA was entering it in the system she realized it was not in the lot numbers provided. Upon investigation of the lot number she realized the vaccine expired 3/31/24. She reported it to Provider and clinic manager. Where provider stated no action was needed.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Pt was given a second dose of the seasonal flu vaccine in error. Pt's mother did not realize that he had already had it earlier in the season and we failed to appropriately review his immunization record where it had been properly documented.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second dose of an influenza vaccine in an error.  We failed to review the immunization record where it was documented properly, and the patient's mother did not remember that he had previously gotten the vaccine in October 2023.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This vaccine is for 6m-11y and the child was 12y and 5 mo at the time of vaccination. The incorrect dose was given, and the patient was under-vaccinated. No harmful effects occurred to the patient
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site reaction, Pain, Pyrexia, Rash macular
Clinical narrative: Fever, redness and blotching at the side of infection. Patient happened to have an appt with her cardiologist who referred her to PCP. Patient was not able to get an appt with PCP due to non urgent nature of symptoms. Patient applied topical lidocaine to help with the pain and has been taking her regular rx of Norco and also applied neosporin.
Age: 56.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Lactation insufficiency
Clinical narrative: Milk supply decreased by over 70%
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site rash, Rash
Clinical narrative: Per mom pt started with rashes on 4/13/24 on arms where pt received vaccines (L) on 4/11/24 and then spread all over arms and face and legs/  is spread all over body including face. Mom gave pt Benadryl last night at 10pm. Mom denies any fever, diarrhea, nausea, and vomiting. no sore throat , sleeping and eating well no shortness of breath or cough./  no travel. no visits. no recent medication use  Dad said he himself has similar rash on arms  has been outdoors but no exposure to plants.  denies new food items or prior allergies
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reports experiencing pain in the arm shot was given (deltoid area). Reports pain started sometime in December; shot was given in October. new onset pain usually occurring at night.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac ablation, Condition aggravated, Dizziness, Influenza like illness, Pain in extremity
Clinical narrative: experienced heart pause every approximately 5 mins; Felt like she was abount to faint; Influenza-like symptoms/experience flu like symptoms; Arm soreness; This serious case was reported by a pharmacist and described the occurrence of sinus arrest in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   The patient's past medical history included sinus arrest (history of heart pauses that was treated with heart ablation) and cardiac ablation.   On 21-MAR-2024, the patient received Shingrix. On 21-MAR-2024, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm soreness). On 22-MAR-2024, the patient experienced influenza-like symptoms (Verbatim: Influenza-like symptoms/experience flu like symptoms). On 23-MAR-2024, the patient experienced sinus arrest (Verbatim: experienced heart pause every approximately 5 mins) (serious criteria GSK medically significant) and felt faint (Verbatim: Felt like she was abount to faint). The outcome of the sinus arrest, felt faint and pain in arm were not resolved and the outcome of the influenza-like symptoms was resolved.   The reporter considered the sinus arrest to be almost certainly related to Shingrix. It was unknown if the reporter considered the felt faint, pain in arm and influenza-like symptoms to be related to Shingrix.     The company considered the sinus arrest to be almost certainly related to Shingrix. It was unknown if the company considered the felt faint, pain in arm and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-APR-2024 The patient had a history of heart pause that was treated with heart ablation procedure.  Prior to receiving Shingrix, the patient did not had this problem. The patient had arm soreness on the same day as that of vaccine received. The patient experienced flu like symptoms and heart paused every 5 minutes, the patient felt like she was about to faint. Follow up was made with patient and it was confirmed that the symptoms were resolving but still occurred but sporadic. The case had been linked to US2024035951, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024035951:Same reporter, different patient
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus arrest
Clinical narrative: experienced heart pause every approximately 5 mins; Felt like she was abount to faint; Influenza-like symptoms/experience flu like symptoms; Arm soreness; This serious case was reported by a pharmacist and described the occurrence of sinus arrest in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   The patient's past medical history included sinus arrest (history of heart pauses that was treated with heart ablation) and cardiac ablation.   On 21-MAR-2024, the patient received Shingrix. On 21-MAR-2024, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm soreness). On 22-MAR-2024, the patient experienced influenza-like symptoms (Verbatim: Influenza-like symptoms/experience flu like symptoms). On 23-MAR-2024, the patient experienced sinus arrest (Verbatim: experienced heart pause every approximately 5 mins) (serious criteria GSK medically significant) and felt faint (Verbatim: Felt like she was abount to faint). The outcome of the sinus arrest, felt faint and pain in arm were not resolved and the outcome of the influenza-like symptoms was resolved.   The reporter considered the sinus arrest to be almost certainly related to Shingrix. It was unknown if the reporter considered the felt faint, pain in arm and influenza-like symptoms to be related to Shingrix.     The company considered the sinus arrest to be almost certainly related to Shingrix. It was unknown if the company considered the felt faint, pain in arm and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-APR-2024 The patient had a history of heart pause that was treated with heart ablation procedure.  Prior to receiving Shingrix, the patient did not had this problem. The patient had arm soreness on the same day as that of vaccine received. The patient experienced flu like symptoms and heart paused every 5 minutes, the patient felt like she was about to faint. Follow up was made with patient and it was confirmed that the symptoms were resolving but still occurred but sporadic. The case had been linked to US2024035951, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024035951:Same reporter, different patient