chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was given an extra dose of PENTACEL (with no reported adverse event); Initial information received on 11-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 years old and unknown gender patient where patient was given an extra dose of 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.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Powder and suspension for suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (extra dose administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence 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: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Pruritic rash started in groin and got worse from there. Dad states he was itching before he got the vaccines. Rash was first noticed within 24 hours of receiving vaccines. Primarily located on lower body and anterior abdomen.  Parents have been treating with Benadryl. Provider prescribing steroid and recommending over the counter Pepcid for additional antihistamine effects
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No signs or symptoms. Patient was given DTAP instead of Tdap.
Age: 2.5
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Encephalitis, Laboratory test, Lumbar puncture, Magnetic resonance imaging abnormal, Pyrexia
Clinical narrative: Am not sure if any of her doctors in the hospital reported this possible adverse reaction.   1 week after the vaccines were given, patient developed prolonged fevers.  Hospitalized.  MRI showed with Encephalitis.  Saw Neurologist, given Steroids, fever resolved.    There are still some pending labs and she has a follow-up scheduled with Neurologist and Hematologist in August.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Dizziness, Gait disturbance, Myalgia
Clinical narrative: Severe muscular and joint pain that made it difficult to walk. Temperature of 102. Nausea and dizziness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Severe muscular and joint pain that made it difficult to walk. Temperature of 102. Nausea and dizziness.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Blood creatine phosphokinase, C-reactive protein, Cellulitis, Differential white blood cell count, Full blood count
Clinical narrative: " Tender erythematous skin rash with clear demarcations, following anthrax immunization ncludes cellulitis vs recurrent episode of arthrus reaction vs other immune reaction given autoantibody  profile."  Treat as cellulitis for now
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Immunisation reaction, Metabolic function test, Rash erythematous, Red blood cell sedimentation rate increased, Tenderness
Clinical narrative: " Tender erythematous skin rash with clear demarcations, following anthrax immunization ncludes cellulitis vs recurrent episode of arthrus reaction vs other immune reaction given autoantibody  profile."  Treat as cellulitis for now
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Type III immune complex mediated reaction
Clinical narrative: " Tender erythematous skin rash with clear demarcations, following anthrax immunization ncludes cellulitis vs recurrent episode of arthrus reaction vs other immune reaction given autoantibody  profile."  Treat as cellulitis for now
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ear pain, Headache, Injection site rash, Pain
Clinical narrative: HEADACHE, HI FEVER , CHILLS , BODY PAIN , EAR PAIN AND RASH BY THE SITE OF INJECTION
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: HEADACHE, HI FEVER , CHILLS , BODY PAIN , EAR PAIN AND RASH BY THE SITE OF INJECTION
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Covid booster from fall 2023 - left arm swelling for approximately 30-45 minutes. swelling resolved with in 17 hours after vaccine
Age: 40.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Headache, Injection site reaction, Urticaria
Clinical narrative: 40 Y.O Female presented to pharmacy for travel vaccines on 07/03/24 for Hepatitis A (RDIM) and Yellow Fever (LASQ) vaccines. Patient also picked up Rx for Vivotif. Patient has no known allergies. Medical history includes Dermatographism. Medications include hormonal contraceptive and Xyzal.    Pt calls pharmacy on 07/16/2024 AM to report sudden onset headache last night (07/15/2024). Patient took Tylenol for her headache, followed by vomiting. Patient took no additional tylenol or other medications. This morning, patient has improvement of symptoms, but reports she feels like her headache is starting to return. Patient reports that she developed welts on her LA at the site of Yellow Fever vaccination one day after she recieved the vaccine, but did not call to inform pharmacy until today. Patient did not take any medication for welts, and has noticed improvement. Denies any other symptoms. Patient confirms she has not yet initiated Vivotif series.    Adverse events associated with Yellow Fever vaccine were re-iterated with patient. Patient was strongly recommended to report to urgent care or emergency room for full workup and further recommendation. Patient was instructed to delay initiation of Vivotif at this time.
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiovascular symptom, Cardioversion, Dyspnoea
Clinical narrative: This was 2nd Moderna vaccine. Within a  couple of days I developed a red rash on face behind knees and on my penis. I had to go see a dermatologist for this in a week post vaccination. Then about 3 weeks later which is a month post vaccination I developed new cardiac symptoms which were pounding heart beats,fatigue, and  S.o.b. I saw a cardiologist and was found to have A-fib. Had cardioversion that lasted only 2 weeks. Then had an ablation. Which lasted 6 months. Then A-fib returns. Watchman was done. Then 2 more cardiversions. A-fib has again returned. Medications tried and do not work. Have A-fib now . Interferes with activities as golf etc.
Sex: M
Vaccine: COVID19-2
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Left atrial appendage closure implant, Loss of personal independence in daily activities
Clinical narrative: This was 2nd Moderna vaccine. Within a  couple of days I developed a red rash on face behind knees and on my penis. I had to go see a dermatologist for this in a week post vaccination. Then about 3 weeks later which is a month post vaccination I developed new cardiac symptoms which were pounding heart beats,fatigue, and  S.o.b. I saw a cardiologist and was found to have A-fib. Had cardioversion that lasted only 2 weeks. Then had an ablation. Which lasted 6 months. Then A-fib returns. Watchman was done. Then 2 more cardiversions. A-fib has again returned. Medications tried and do not work. Have A-fib now . Interferes with activities as golf etc.
Sex: M
Vaccine: COVID19-2
Symptoms: Palpitations, Penile dermatitis, Rash, Rash erythematous, Therapeutic product ineffective
Clinical narrative: This was 2nd Moderna vaccine. Within a  couple of days I developed a red rash on face behind knees and on my penis. I had to go see a dermatologist for this in a week post vaccination. Then about 3 weeks later which is a month post vaccination I developed new cardiac symptoms which were pounding heart beats,fatigue, and  S.o.b. I saw a cardiologist and was found to have A-fib. Had cardioversion that lasted only 2 weeks. Then had an ablation. Which lasted 6 months. Then A-fib returns. Watchman was done. Then 2 more cardiversions. A-fib has again returned. Medications tried and do not work. Have A-fib now . Interferes with activities as golf etc.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Portal vein thrombosis, Stent placement, Swelling
Clinical narrative: Abdominal pain, portal vein thrombosis, hospitalization where stint was placed in portal vein, extreme internal swelling which appeared appeared to be a cancerous mass
Age: 88.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Arthralgia, Asthenia, Erythema, Injected limb mobility decreased, Movement disorder
Clinical narrative: Could not move left arm and terrible pain.  Was weak like never before and no energy.  Throuing up for two days  I still have trouble with arm.  Do exercise and pool classes. Had cortisone shot 7/3  I am an active and physically fit 88 year old woman with excellent mental acuity.  On June 4th at 4:45 pm, I received a COVID shot in my right upper arm at clinic provided by my PCP, Dr.  The next day on June 5th at 10:20 am, I brought my husband to clinic for his COVID shot, and the nurse in the Triage office, gave me an RSV shot in my left upper arm. That same evening, my body collapsed from weakness, the pain was a ten (scale 1-10) in my left arm. I could not lift my left arm and had absolutely no strength in my body. The upper arm was red, with hot severe pain, unlike anything I have experienced before. I was vomiting for two days, unable to keep nutrition down.   On June 11th at 4:20pm, I went to see a Physician Assistant at clinic. Due to experiencing weakness and lots of pain in my left arm as it spread to other body joints. The PA was concerned that I might have had a stroke due to weakness in my left leg. My left leg has resolved itself thankfully.   On June 25th at 5:40pm, I had a conversation with my PCP Dr. at clinic highlighting the severity of my ongoing symptoms. I have not been the same as before the shots were administered. I still have pain and difficulty with left arm movements. Also my energy is much less now.   I want to bring this to the attention of VERS, because I am concerned about how close the vaccines were given and what happened to me. I want to make sure this does not happen to anyone else.   Thank you for your attention to this matter,
Age: 88.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Muscular weakness, Pain, Pain in extremity, Skin warm, Syncope
Clinical narrative: Could not move left arm and terrible pain.  Was weak like never before and no energy.  Throuing up for two days  I still have trouble with arm.  Do exercise and pool classes. Had cortisone shot 7/3  I am an active and physically fit 88 year old woman with excellent mental acuity.  On June 4th at 4:45 pm, I received a COVID shot in my right upper arm at clinic provided by my PCP, Dr.  The next day on June 5th at 10:20 am, I brought my husband to clinic for his COVID shot, and the nurse in the Triage office, gave me an RSV shot in my left upper arm. That same evening, my body collapsed from weakness, the pain was a ten (scale 1-10) in my left arm. I could not lift my left arm and had absolutely no strength in my body. The upper arm was red, with hot severe pain, unlike anything I have experienced before. I was vomiting for two days, unable to keep nutrition down.   On June 11th at 4:20pm, I went to see a Physician Assistant at clinic. Due to experiencing weakness and lots of pain in my left arm as it spread to other body joints. The PA was concerned that I might have had a stroke due to weakness in my left leg. My left leg has resolved itself thankfully.   On June 25th at 5:40pm, I had a conversation with my PCP Dr. at clinic highlighting the severity of my ongoing symptoms. I have not been the same as before the shots were administered. I still have pain and difficulty with left arm movements. Also my energy is much less now.   I want to bring this to the attention of VERS, because I am concerned about how close the vaccines were given and what happened to me. I want to make sure this does not happen to anyone else.   Thank you for your attention to this matter,
Age: 88.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Vomiting
Clinical narrative: Could not move left arm and terrible pain.  Was weak like never before and no energy.  Throuing up for two days  I still have trouble with arm.  Do exercise and pool classes. Had cortisone shot 7/3  I am an active and physically fit 88 year old woman with excellent mental acuity.  On June 4th at 4:45 pm, I received a COVID shot in my right upper arm at clinic provided by my PCP, Dr.  The next day on June 5th at 10:20 am, I brought my husband to clinic for his COVID shot, and the nurse in the Triage office, gave me an RSV shot in my left upper arm. That same evening, my body collapsed from weakness, the pain was a ten (scale 1-10) in my left arm. I could not lift my left arm and had absolutely no strength in my body. The upper arm was red, with hot severe pain, unlike anything I have experienced before. I was vomiting for two days, unable to keep nutrition down.   On June 11th at 4:20pm, I went to see a Physician Assistant at clinic. Due to experiencing weakness and lots of pain in my left arm as it spread to other body joints. The PA was concerned that I might have had a stroke due to weakness in my left leg. My left leg has resolved itself thankfully.   On June 25th at 5:40pm, I had a conversation with my PCP Dr. at clinic highlighting the severity of my ongoing symptoms. I have not been the same as before the shots were administered. I still have pain and difficulty with left arm movements. Also my energy is much less now.   I want to bring this to the attention of VERS, because I am concerned about how close the vaccines were given and what happened to me. I want to make sure this does not happen to anyone else.   Thank you for your attention to this matter,
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inflammation, Injection site erythema, Injection site pruritus, Local reaction
Clinical narrative: Localized inflammatory Reaction with pruritic, pink skin measuring  4in x 5in in left upper arm
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Numbness and tingling from my feet that progressed up yo my chest; Numbness and tingling from my feet that progressed up yo my chest; This is a spontaneous report received from a Nurse.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jun2022 at 14:00 as dose 4 (booster), single (Lot number: FP7135) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing). Concomitant medication(s) included: VIT D [VITAMIN D NOS]. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FJ1620, Administration time: 10:15), administration date: 30Dec2021, when the patient was 52-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (disability), PARAESTHESIA (disability) all with onset 07Jul2022, outcome "not recovered" and all described as "Numbness and tingling from my feet that progressed up yo my chest". The events "numbness and tingling from my feet that progressed up yo my chest" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia. Clinical Course: Patient had no Known allergies.; Sender's Comments: A possible contribution of suspect drug BNT162b2 (BNT162B2) cannot be excluded for reported events hypoaesthesia & paraesthesia given compatible time association. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Mar2021, for Covid-19 Immunization. The following information was reported: ATRIAL FLUTTER (non-serious) with onset May2021, 1 month after the suspect product(s) administration, outcome "unknown", described as "A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion". The events "a month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion" required physician office visit. Therapeutic measures were taken as a result of atrial flutter.  Clinical course: Caller got the Pfizer covid vaccine in March 2021 and the second in April 2021.  A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion.  He ask the cardiologist if he thought this was related to the vaccine and he said he didn't think so but couldn't categorically say it wasn't.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400215601 same patient, different dose number and event;US-PFIZER INC-202400215603 same reporter/drug, different patient and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial flutter
Clinical narrative: A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Mar2021, for Covid-19 Immunization. The following information was reported: ATRIAL FLUTTER (non-serious) with onset May2021, 1 month after the suspect product(s) administration, outcome "unknown", described as "A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion". The events "a month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion" required physician office visit. Therapeutic measures were taken as a result of atrial flutter.  Clinical course: Caller got the Pfizer covid vaccine in March 2021 and the second in April 2021.  A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion.  He ask the cardiologist if he thought this was related to the vaccine and he said he didn't think so but couldn't categorically say it wasn't.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400215601 same patient, different dose number and event;US-PFIZER INC-202400215603 same reporter/drug, different patient and event;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Mar2021, for Covid-19 Immunization. The following information was reported: ATRIAL FLUTTER (non-serious) with onset May2021, 1 month after the suspect product(s) administration, outcome "unknown", described as "A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion". The events "a month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion" required physician office visit. Therapeutic measures were taken as a result of atrial flutter.  Clinical course: Caller got the Pfizer covid vaccine in March 2021 and the second in April 2021.  A month later he was at the dentist and the dentist noticed an issue with his pulse and sent him right to see the cardiologist who said he had atrial flutter and they did a cardioversion.  He ask the cardiologist if he thought this was related to the vaccine and he said he didn't think so but couldn't categorically say it wasn't.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400215601 same patient, different dose number and event;US-PFIZER INC-202400215603 same reporter/drug, different patient and event;
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, PNC20, RV5
Symptoms: Injection site mass
Clinical narrative: About 4 days after vaccine was given, patient developed left anterior thigh developed linear area of hyperpigmentation with underlying nodule, consistent with scar tissue or keloid.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, DTPPVHBHPB, PNC20, RV5
Symptoms: Injection site discolouration, Injection site nodule, Injection site scar
Clinical narrative: About 4 days after vaccine was given, patient developed left anterior thigh developed linear area of hyperpigmentation with underlying nodule, consistent with scar tissue or keloid.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: multiple individuals 65+ years old who posted online about receiving vaccination with GARDASIL 9.; No additional AE/PQC.; This spontaneous report was received from a consumer and refers to a multiple patients of more than 65-year-old of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown dates, the patients were vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), (dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (experienced product administered to patient of inappropriate age). No additional adverse events were reported.
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no side effects; Medical Assistant called to report that a 15 Month old patient was given a dose of PROQUAD  X026409 5/7/2025 0.5ML, and VARIVAX X011425 4/19/2025 0.5ML during the same office visit on 7/1/2024.; Medical Assistant called to report that a 15 Month old patient was given a dose of PROQUAD  X026409 5/7/2025 0.5ML, and VARIVAX X011425 4/19/2025 0.5ML during the same office visit on 7/1/2024.; This spontaneous report was received from a medical assistant concerning a 15-months-old patient of unknown gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 01-JUL-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot #X026409, expiration date: 07-MAY-2025; and  varicella virus vaccine live (oka/merck) (VARIVAX) lot #X011425, expiration date: 19-APR-2025, both injection at a dose of 0.5 ml/once administered for prophylaxis (strength, and route of administration were not provided) (wrong vaccine administered/ extra dose administered).  Medical assistant reported no side effects.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Blood test normal, Pain, Urine analysis normal, X-ray normal
Clinical narrative: Patient started experiencing pain in lower abdomen a few days after the shot. The pain started to radiate to patient's back (only on the right side) - does not reach the spinal cord.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects were mentioned. No additional AE/PQC.; HCP called to report a T/E where GARDASIL-9 was administered to a patient. Temperature: 49.4F T; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 12-JUL-2024, the patient was vaccinated by a health professional with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, involved lot # was X019625, expiration date: 23-APR-2025 (verified to be valid), administered as prophylaxis (strength, anatomical location and route of administration were not provided). Temperature excursion was 49.4 degree Fahrenheit (F) for 0 hours 30 minutes 0 seconds. No side effects were mentioned. No additional AE/PQC.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administration of a Hib vaccine that was given with a sertile solution diluent instead of the sodium chloride diluent that comes with the vaccine with no reported ae; Initial information received on 03-Jul-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient with administration of HAEMOPHILUS TYPE B (HIB) VACCINE that was given with a sertile solution diluent instead of the sodium chloride diluent that comes with the vaccine with no reported ae (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 suspect HAEMOPHILUS TYPE B (HIB) VACCINE produced by unknown manufacturer via unknown route in unknown administration site for immunization (strength, dose, batch number and expiry date unknown)with a sertile solution diluent instead of the sodium chloride diluent that comes with the vaccine with no reported ae (product preparation error) (same day latency). Information on batch number corresponding to the one at time of event occurrence 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.   Additional information was received on 05-Jul-2024 via other health professional: case validity upgraded to valid, event details, product details added text amended accordingly.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Immunisation reaction, Infant irritability, Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local vaccine reaction. Area of Pediarix shot -  red and firm. 8.5cm x 4.5cm at 12pm on 7/16/24,  8.75cm x 4.5cm by 4:20pm on 7/16/24. Pt was fussy. Afebrile. Provider instructions - take Zyrtec 2.5mg daily. Apply ice. Call or be seen if fever, increasing size, drainage, worsening behavior etc. No systemic effects at time of evaluation.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Decreased appetite, Infant irritability, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Local vaccine reaction. Area of Pediarix shot -  red and firm. 8.5cm x 4.5cm at 12pm on 7/16/24,  8.75cm x 4.5cm by 4:20pm on 7/16/24. Pt was fussy. Afebrile. Provider instructions - take Zyrtec 2.5mg daily. Apply ice. Call or be seen if fever, increasing size, drainage, worsening behavior etc. No systemic effects at time of evaluation.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Therapy cessation
Clinical narrative: Pt called on 7/15/2024 to report that she's still itching, and she thinks it may be from the Shingrix vaccine that she received on 7/1/2024. She started getting itchiness 2-3 days after the injection. She thought it was maybe from one of her medications, so she stopped her medications, continued to take an antihistamine, which she thinks is benadryl, but the itchiness was still there. She said taking the antihistamine helped, but once the antihistamine wears off, the itchiness returns. Pt said she hasn't changed any lotions, soaps, perfumes, etc. the only thing that was different was the shingrix vaccine. Pt has no other symptoms, except some tiny bumps once in a while.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Rash
Clinical narrative: Patient developed rash all over body, no fever.  Tylenol, motrin, benadryl advised
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Day following injection began to have redness, swelling at injection site. Day 3 increased redness, swelling and pain at injection site. Patient returned to Public Health for tb test read and informed nurse of site. Redness 65x70 mm, area warm to touch, no drainage noted at site. Advised recommendation to go to urgent care for follow. Patient agreed.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Asthenia, Blood test, Catheterisation cardiac, Chest pain
Clinical narrative: I woke up with intense pain bilaterally around my ribs into my sternum. I had intense pain down both arms, and both hands including intense tingling and shooting pain.  I had intense stomach pain unlike a normal upset stomach. The intense pain extended to my shoulder blades as well. I was seen in the Emergency room for debilitating pain on two occasions and subsequently admitted for 4 days.  I have seen a plethora of specialists since the initial event and continue to be unwell.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram, Electrocardiogram, Electromyogram, Magnetic resonance imaging, Malaise
Clinical narrative: I woke up with intense pain bilaterally around my ribs into my sternum. I had intense pain down both arms, and both hands including intense tingling and shooting pain.  I had intense stomach pain unlike a normal upset stomach. The intense pain extended to my shoulder blades as well. I was seen in the Emergency room for debilitating pain on two occasions and subsequently admitted for 4 days.  I have seen a plethora of specialists since the initial event and continue to be unwell.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: I woke up with intense pain bilaterally around my ribs into my sternum. I had intense pain down both arms, and both hands including intense tingling and shooting pain.  I had intense stomach pain unlike a normal upset stomach. The intense pain extended to my shoulder blades as well. I was seen in the Emergency room for debilitating pain on two occasions and subsequently admitted for 4 days.  I have seen a plethora of specialists since the initial event and continue to be unwell.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: I woke up with intense pain bilaterally around my ribs into my sternum. I had intense pain down both arms, and both hands including intense tingling and shooting pain.  I had intense stomach pain unlike a normal upset stomach. The intense pain extended to my shoulder blades as well. I was seen in the Emergency room for debilitating pain on two occasions and subsequently admitted for 4 days.  I have seen a plethora of specialists since the initial event and continue to be unwell.
Age: 0.58
Sex: F
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Multiple food allergies including peanut, egg, and dairy. No history of any food/drug allergies in family.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Not indicated for age
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Bone scan normal, Pain in extremity
Clinical narrative: Severe bone and joint pain. Mostly in hips, legs and feet
Age: 2.0
Sex: F
Vaccine: HEPA, PNC15
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient?s right thigh had redness and swelling covering 90% of the top of thigh.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Headache, Insomnia, Lethargy
Clinical narrative: At 6:20, symptom - itching, as if had bugs under my skin; aching in neck, shoulders, arm. 7:40 symptoms: "pricking" nerve pain in Left arm - random, chills, lethargy, severe headache, and tinnitus, which would last throughout the night and produced nausea (no vomiting) and unable to sleep until around 2:00 pm the next day.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Neck pain, Neuralgia, Pain in extremity, Pruritus
Clinical narrative: At 6:20, symptom - itching, as if had bugs under my skin; aching in neck, shoulders, arm. 7:40 symptoms: "pricking" nerve pain in Left arm - random, chills, lethargy, severe headache, and tinnitus, which would last throughout the night and produced nausea (no vomiting) and unable to sleep until around 2:00 pm the next day.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Tinnitus
Clinical narrative: At 6:20, symptom - itching, as if had bugs under my skin; aching in neck, shoulders, arm. 7:40 symptoms: "pricking" nerve pain in Left arm - random, chills, lethargy, severe headache, and tinnitus, which would last throughout the night and produced nausea (no vomiting) and unable to sleep until around 2:00 pm the next day.
Age: 80.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: red spots on left arm around injection site swelling and warm to touch at injection site very painful
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Not indicated age
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Pain
Clinical narrative: chills, fatigue, redness, heat,  swelling, size of deck of cards, achy, using ice when I can, taking ibuprofen when needed.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: chills, fatigue, redness, heat,  swelling, size of deck of cards, achy, using ice when I can, taking ibuprofen when needed.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: A small red area appearred on 6/29/24 around 7:00 pm. At 8:00 am on 6/30/24 the area was much larger and warm to the touch. At 5:00 that day the area was even larger. Pt applied benedryl gel and cool compresses, but the area continued to be red, warm and swollen through 7/1/24. On 7/2/24 at 6:15 am the symptoms started to improve and continued to improve over time. As of this date the symptoms are completely resolved.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscle tightness, Pain, Pain in extremity
Clinical narrative: Patient received Tdap booster, administered to her left deltoid on 7/8/24. She returned for an additional appointment on 7/16/24 to address issues with her left upper extremity. At that visit, the patient reported pain in left arm, radiating down to fingers, started on later in the day on 7/8/24. Patient stated she will get a stabbing pain to injection site with certain movements. They last a few seconds, happen approximately 10-15 times per day. Patient was unable to recreate. She can move arm a certain way and will happen one time, but not the next. No weakness to grip. Range of motion is normal. At nighttime, patient reported whole arm feels more tight, like it needs to be stretched out. Per patient, she has received tetanus boosters in past without concerns. She denied any redness, swelling or warmth at injection site.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: The patient began to feel light-headed a minute or 2 after her vaccines were received. She lost consciousness for several seconds in a seated position with her head between her knees. After sitting with her head down and cool compresses on neck and forehead the patient still felt dizzy and nauseous. Parent assisted RN to help the patient to the floor to lie down with knees up. It took another 10-15 minutes for patient to be ready to sit up. Patient refused water, juice and candy due to nausea. Once she sat back up she sipped some water. Patient and parents agreed that pt was ready to get up and go home after sitting up for 10-15 minutes.. RN walked Pt to the car along with her father.
Age: 12.0
Sex: F
Vaccine: HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Headache, Pallor
Clinical narrative: Patient was noticeably pale and  wheelchair  back into vaccination clinic. Patient was placed on her back on the ground. School district nurse called EMS at 6:37pm and started recounting details to dispatcher. Nurse took primary vitals, 78 pulse, 118/83 blood pressure, and 99% pulse ox at 6:40pm.  RN applied wet, cold towel to patient?s face and neck and passive leg raised. Vitals continued to be taken every two minutes by RN, remaining in a normal range. Patient became responsive and oriented by 6:42pm. Vitals were 123/87 bp, 98% pulse ox. Responded to questions appropriately and claimed she had a headache. Patient was place in recovery position on ground at 6:44. 77 pulse, 121/78 bp, and 99% pulse ox at 6:45. Paramedics arrived at 6:48. Report was given to EMS, who then took over care. EMS mentioned vasovagal symptoms. Family refused to be taken to emergency room. The patient was discharged by paramedics around 7:00 pm and was taken to their vehicle in wheelchair by
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Hep B given instead of HIB. Dr. and parent notified.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: DEVELOPMENT OF REDNESS, WARMTH AND FIRMNESS TO RIGHT ARM.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Death
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Vasovagal syncope within 30 to 45 seconds of vaccine, lasting about 15 seconds.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given adult dose of Hepatitis B vaccine instead of pediatric.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Gardasil was ordered to be given to patient. Tdap was given in error. Patient did not have any adverse signs or symptoms after being evaluated by Nurse Practioner that patient was scheduled with.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Ear pain, Lymphadenopathy, Papilloedema, Sinus congestion, Toothache
Clinical narrative: Patient stated by 10 pm the evening of the vaccine she had severe swollen glands in neck, swollen behind eyes, ears and teeth hurting, along with swollen sinuses. No tongue swelling. She took Benadryl before bedtime that relieved the symptoms.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Constipation, Decreased appetite, Fatigue
Clinical narrative: After shot:  blisters in mouth, constipation, arm sore/itchy/aching, tinnitus, tired, muscle aches, sore throat, nausea, pain arm/shoulder, loss of appetite, bloat, swollen lip. - NOW extreme pain at injection site, radiating up shoulder and neck.  3 months.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lip swelling, Myalgia, Nausea, Neck pain
Clinical narrative: After shot:  blisters in mouth, constipation, arm sore/itchy/aching, tinnitus, tired, muscle aches, sore throat, nausea, pain arm/shoulder, loss of appetite, bloat, swollen lip. - NOW extreme pain at injection site, radiating up shoulder and neck.  3 months.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oropharyngeal pain, Pain, Pain in extremity, Pruritus
Clinical narrative: After shot:  blisters in mouth, constipation, arm sore/itchy/aching, tinnitus, tired, muscle aches, sore throat, nausea, pain arm/shoulder, loss of appetite, bloat, swollen lip. - NOW extreme pain at injection site, radiating up shoulder and neck.  3 months.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After shot:  blisters in mouth, constipation, arm sore/itchy/aching, tinnitus, tired, muscle aches, sore throat, nausea, pain arm/shoulder, loss of appetite, bloat, swollen lip. - NOW extreme pain at injection site, radiating up shoulder and neck.  3 months.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Patient is a 65yr female who presents with possible reaction to prevnar injection, given 7/9/2024, left arm. Had been sore but this am, she noticed arm was itchy, raised and red.  Used frankincense, helichrysym with castor oil base.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema, warmth, pruritis at injections site.
Age: 10.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given kinrix at 10 years of age and vaccine is recommended for 4 - 6 Years of age .
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Lymphadenopathy, Muscle swelling
Clinical narrative: Got a Tetanus injection - in the back of arm (however typically they are given IM in the deltoid) - right bicep is swollen almost twice as big than left. Lymphnoid swelling inner elbow, tenderness of arm and slight heat and redness near injection site.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered at inappropriate site, Tenderness
Clinical narrative: Got a Tetanus injection - in the back of arm (however typically they are given IM in the deltoid) - right bicep is swollen almost twice as big than left. Lymphnoid swelling inner elbow, tenderness of arm and slight heat and redness near injection site.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, MMRV, TDAP
Symptoms: Dyskinesia, Syncope
Clinical narrative: Syncopial event with abnormal body movement observed. Glucose given immediately after patient stable, icepack placed to forehead, and supine position with legs elevated to heart level for 15 minutes.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Blood glucose increased, Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Patient contacts the Health Center and reports warmth, swelling, redness and describes a "hard knot" at injection site beginning one day post immunization. Two days post immunization, patient reports the development of blisters at injection site, stiff neck and abnormal elevated blood sugar readings. Patient S/S have subsided as of 07/16/2024. Patient visited with PCP on 07/16/2024 for further management of s/s.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Injection site vesicles, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Patient contacts the Health Center and reports warmth, swelling, redness and describes a "hard knot" at injection site beginning one day post immunization. Two days post immunization, patient reports the development of blisters at injection site, stiff neck and abnormal elevated blood sugar readings. Patient S/S have subsided as of 07/16/2024. Patient visited with PCP on 07/16/2024 for further management of s/s.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Deafness, Dizziness, Dyspnoea
Clinical narrative: About one minute after the shot, my vision got really bright and my heart started beating really fast. I began to feel nauseous and lightheaded and my hearing became a bit dull. I felt short of breath and I blacked out. I was probably unconscious for less than 20 seconds. When I came to, my vision was still very bright, and my hearing was very dull. It felt like I had cotton in my ears. I was still short of breath. I started sweating profusely. I was dripping sweat, my clothes were soaking wet and that probably lasted around 2 to 3 minutes. I still felt nauseous and sick to my stomach and very scared. It took about 10 minutes for me to feel normal again, though I still felt very weak and shaky.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Hyperhidrosis, Loss of consciousness, Nausea, Nervousness
Clinical narrative: About one minute after the shot, my vision got really bright and my heart started beating really fast. I began to feel nauseous and lightheaded and my hearing became a bit dull. I felt short of breath and I blacked out. I was probably unconscious for less than 20 seconds. When I came to, my vision was still very bright, and my hearing was very dull. It felt like I had cotton in my ears. I was still short of breath. I started sweating profusely. I was dripping sweat, my clothes were soaking wet and that probably lasted around 2 to 3 minutes. I still felt nauseous and sick to my stomach and very scared. It took about 10 minutes for me to feel normal again, though I still felt very weak and shaky.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noticed. Patient received 2 doses of menqaudfi