chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product contamination physical, Product use issue
Clinical narrative: inappropriate use due to the administration of a product that may have had a particulate in the vial when the vaccine was drawn into a syringe and administered to a patient with no reported adverse event; Initial information received on 03-Sep-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and the reporter reported inappropriate use due to the administration of IPV (Vero) [Imovax polio] that had a particulate in the vial when the vaccine was drawn into a syringe and administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On 03-Sep-2024, the patient received a dose of suspect IPV (VERO) suspension for injection (unknow strength, dose and route) with (lot W1C741M, expiry date 17-Nov-2025 ) in unknown administration site for immunization with inappropriate use due to the administration of a product that may have had a particulate in the vial when the vaccine was drawn into a syringe and administered to a patient with no reported adverse event (poor quality Vaccine administered) (latency same day).  Reportedly, When the product was administered, there were no visible particulates in the vial. However, they noticed a small, light gray particulate floating around in the vial after it had been administered. They believe it was part of the rubber stopper that had gone into the vial since the particulate appears to be the same color. The particulate is about the size of a small spec of pepper. They were only able to see it because it was moving around in the vial.  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.  Senders comment: Reporter can be contacted by Sanofi: Yes
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: stored in cooler during transit after storm/power outage/Max/low temperature reached: NEGATIVE (with no reported adverse event); administered post-excursion (with no reported adverse event); Initial information received on 03-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to other case 2024SA258508.   This case involves an unknown age and gender patient and reporter reported Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] stored in cooler during transit after storm/power outage/max/low temperature reached: negative (with no reported adverse event) and administered post-excursion (with no reported adverse event).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Caller reported that Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (unknown batch number, strength, dose and expiry date) for immunization was stored in cooler during transit from 23-AUG-2024 through 26-AUG-2024 after storm/power outage/max/low temperature reached: negative NEGATIVE 7.6 C Duration: 22 hours (with no reported adverse event) (product storage error) and was administered post-excursion (with no reported adverse event) (poor quality product administered) (latency- same day) administered via unknown route in unknown administration site for immunization.  Information on the batch number was requested corresponding to the one at time of event occurrence.   Reportedly, Caller reported a cold temperature excursion that occurred during transit. When the storm-related power outage occurred, the vaccines were placed/stored over the weekend in a cooler. Caller previously reported a warm temperature excursion that occurred during the same storm related power outage, but they did not realize that the products had also experienced a cold excursion as well.   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.; Sender's Comments:  US-SA-2024SA258508:02207487
Age: 16.0
Sex: F
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered flublok to a 16-year-old patient with no reported adverse event; Initial information received on 04-Sep-2024 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Influenza trivalent recombinant vaccine [Flublok TIV] administered to a 16-year-old patient 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 16-year-old patient received an unknown dose of influenza trivalent recombinant vaccine Solution for injection (lot TFAA2401 and expiry date 01-APR-2025) via unknown route in unknown administration site for Immunization with no adverse event (product administered to patient of inappropriate age) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 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: 19.0
Sex: F
Vaccine: MEN
Symptoms: Subclavian vein thrombosis
Clinical narrative: blood clot in the right subclavian vein, 3 to 4 weeks after menquadfi was given; Initial information received on 05-Sep-2024 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 19 years old female patient who had Blood Clot in the right subclavian vein, 3 to 4 weeks after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Aug-2024, the patient received a  dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (unknown batch number, strength and expiry date) via unknown route in unknown administration site for immunization.  Information on the batch number was requested corresponding to the one at time of event occurrence.  On 28-Aug-2024, the patient developed Blood Clot in the right subclavian vein, 3 to 4 weeks after Menquadfi was given (subclavian vein thrombosis) ( latency-26 days) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness Criteria: The event Subclavian Vein Thrombosis was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated on 10-Sep-24: This case involves a 19 years old female patient who had Blood Clots after getting the menquadfi vaccine/ Blood Clot in the right subclavian vein, 3 to 4 weeks after Menquadfi was given after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi]. Based on the limited information provided regarding this case, causal role of the company suspect vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, event details, past medical and drug history, concurrent illnesses and concomitant medications.
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Dyskinesia, Dyspnoea, Fatigue, Hypotension
Clinical narrative: Syncope with involuntary jerking movements for 5 to 10 seconds; low blood pressure; shortness of breath; dizziness; fatigue; Initial information received on 05-Sep-2024 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 12-year-old female patient who experienced syncope with involuntary jerking movements for 5 to 10 seconds, low blood pressure, shortness of breath, dizziness and fatigue after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2024, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of lot U8194AA and expiry date: 30-Sep-2027 via intramuscular route in the right deltoid for immunization.  On 29-AUG-2024 the patient developed syncope with involuntary jerking movements for 5 to 10 seconds (syncope), low blood pressure (hypotension), shortness of breath (dyspnoea), dizziness and fatigue (latency: on same day) following the administration of vaccine.   Seriousness criteria: The event syncope was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.; Sender's Comments: Sanofi company comment dated 10-Sep-2024: This case involves a 12-year-old female patient who experienced syncope with involuntary jerking movements for 5 to 10 seconds, low blood pressure, shortness of breath, dizziness and fatigue after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2024SA261812:
Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Syncope
Clinical narrative: Syncope with involuntary jerking movements for 5 to 10 seconds; low blood pressure; shortness of breath; dizziness; fatigue; Initial information received on 05-Sep-2024 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 12-year-old female patient who experienced syncope with involuntary jerking movements for 5 to 10 seconds, low blood pressure, shortness of breath, dizziness and fatigue after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2024, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of lot U8194AA and expiry date: 30-Sep-2027 via intramuscular route in the right deltoid for immunization.  On 29-AUG-2024 the patient developed syncope with involuntary jerking movements for 5 to 10 seconds (syncope), low blood pressure (hypotension), shortness of breath (dyspnoea), dizziness and fatigue (latency: on same day) following the administration of vaccine.   Seriousness criteria: The event syncope was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.; Sender's Comments: Sanofi company comment dated 10-Sep-2024: This case involves a 12-year-old female patient who experienced syncope with involuntary jerking movements for 5 to 10 seconds, low blood pressure, shortness of breath, dizziness and fatigue after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2024SA261812:
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: got a second Arexvy vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (on December 12th 2023, received 1st dose).   On 10-AUG-2024, the patient received the 2nd dose of Arexvy. On 10-AUG-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: got a second Arexvy vaccine). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 05-SEP-2024 Nurse stated that a patient had Arexvy vaccine but she forgot that already received the vaccine and got a second Arexvy vaccine, which led to extra dose administered. She had not had any AEs so far.  Consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Single component of a two-component product administered
Clinical narrative: just had dosed the liquid  without reconstituting the powder component"; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: just had dosed the liquid  without reconstituting the powder component") and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication was unknown and the outcome of the inappropriate dose of vaccine administered was not reported.   Additional Information: GSK receipt date: 05-SEP-2024 The pharmacist reported that called about the menveo vaccine, they had an incident where just had dosed the liquid  without reconstituting the powder component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered Consented to follow up. The case is linked with US2024110795, by same reporter.; Sender's Comments:  US-GSK-US2024110795:Same reporter/ different patient
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site was just a little sore, which is typical from previous COVID shots; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6203) at the age of 79 years, in right arm for COVID-19 immunisation. The patient's relevant medical history included: "breast cancer", start date: 1999 (unspecified if ongoing), notes: 25 years ago (does not get anything in left arm because of breast cancer). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site was just a little sore, which is typical from previous COVID shots".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400252152 Same patient and drug, similar event, different dose;
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site was just a little sore , which is typical from previous Covid shots; This is a spontaneous report received from a Consumer or other non HCP.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Dec2022 as dose 5 (booster), single (Lot number: GJ6738) at the age of 81 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer", start date: 1999 (unspecified if ongoing), notes: 25 years ago. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot number: EN6203, in right arm), administration date: 01Mar2021, when the patient was 79-year-old, for COVID-19 immunisation, reaction(s): "injection site was just a little sore, which is typical from previous Covid shots"; BNT162b2 (Dose 2, Lot number: ER8727, in right arm), administration date: 23Mar2021, when the patient was 79-year-old, for COVID-19 immunisation, reaction(s): "injection site was just a little sore, which is typical from previous Covid shots"; BNT162b2 (Dose 3, Lot number: FH8027, in right arm), administration date: 09Nov2021, when the patient was 80-year-old, for COVID-19 immunisation, reaction(s): "injection site was just a little sore, which is typical from previous Covid shots"; BNT162b2 (Dose 4, Lot number: FK9893, in right arm), administration date: 21Apr2022, when the patient was 80-year-old, for COVID-19 immunisation, reaction(s): "injection site was just a little sore, which is typical from previous Covid shots". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site was just a little sore , which is typical from previous Covid shots".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400252152 Same patient and drug, similar event, different dose;
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Memory impairment, Mood altered
Clinical narrative: moods were off, and I had no desire to go anywhere or do anything. I became anxious and short term memory is slipping; moods were off, and I had no desire to go anywhere or do anything. I became anxious and short term memory is slipping; moods were off, and I had no desire to go anywhere or do anything. I became anxious and short term memory is slipping; This is a spontaneous report received from a Nurse.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2022 at 13:00 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing); "NKA allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for Covid-19 immunization. The following information was reported: MOOD ALTERED (non-serious), ANXIETY (non-serious) all with onset 01Feb2023 at 12:00, outcome "not recovered" and all described as "moods were off, and I had no desire to go anywhere or do anything. I became anxious and short term memory is slipping"; MEMORY IMPAIRMENT (non-serious) with onset 01Feb2023 at 12:00, outcome "not recovered", described as "moods were off, and I had no desire to go anywhere or do anything. I became anxious and short term memory is slipping". The events "moods were off, and i had no desire to go anywhere or do anything. i became anxious and short term memory is slipping" required physician office visit. Therapeutic measures were taken as a result of mood altered, anxiety, memory impairment.  Additional information: The patient informed that she did not receive any other vaccines on the same date and any other vaccines within 4 weeks prior to the vaccine(s) for which she was reporting. The patient was not taking any other medications within 2 weeks of the event starting. The reporter stated "I had no choice but to receive this covid vaccine or I'd lose my job. I noticed my moods were off, and I had no desire to go anywhere or do anything. I became anxious and short term memory is slipping. I know 100% my mental health problem is from this vaccine. It ruined my life. I think I deserve some money for this horrible adverse event. I'm a nurse and can barely take care it myself." The patient informed that treatment was Psychiatrist monthly with huge bill.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Antibody test, Poor quality product administered, Product storage error, Vaccine induced antibody absent
Clinical narrative: A titre was performed and the patient did not have immunity; was given Pentacel and the pediatrician said the refrigerator was compromised; Initial information received on 29-Aug-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] and the pediatrician said the refrigerator was compromised and a titre was performed, and the patient did not have immunity   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in January 2024, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site as Prophylactic Vaccination (immunization) and the pediatrician said the refrigerator was compromised (poor quality product administered)(latency: on same day).   Information regarding batch number corresponding to the one at time of event occurrence is requested.  On an unknown date, a titre was performed, and the patient did not have immunity (vaccine induced antibody absent) (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event vaccine induced antibody absent.  At time of reporting, the outcome was Unknown for the event vaccine induced antibody absent.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Ear pain, Fatigue, Headache, Mobility decreased
Clinical narrative: fever 100' ; fatigue; headache (never have); ear pain; sinus pain; muscle spasms L eye upper and lower lid. Confined to bed all next day Saturday. By Sunday, fever, headache, pain resolved. Muscle spasms continue, less frequently but not gone.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinus pain
Clinical narrative: fever 100' ; fatigue; headache (never have); ear pain; sinus pain; muscle spasms L eye upper and lower lid. Confined to bed all next day Saturday. By Sunday, fever, headache, pain resolved. Muscle spasms continue, less frequently but not gone.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: extra dose given
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased, Loss of personal independence in daily activities, Swelling
Clinical narrative: Left shoulder pain, swelling, loss of range of motion within 30 minutes. Patient is no longer able to dress herself.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Patient developed wide spread rash across her body, starting around 2 weeks after vaccine administration, with most severe areas being on her legs.  Patient waited around 1 month from onset before seeing her dermatologist.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal menstrual clots, Adnexa uteri pain, Amenorrhoea, Anxiety, Arthralgia
Clinical narrative: Within one minute after the shot I felt as though I'd faint. I became dizzy and thought I would pass out. I held onto a shelf to steady myself and breathed deeply for a few minutes until I no longer felt like fainting, but dizziness persisted for about 15-20 minutes. Within 8 hours I began to experience severe Covid symptoms (I'd had Covid twice before) that lasted two weeks. I had severe joint pain in my knees, elbows, ankles, and wrists that I'd never felt before. This pain appears still 3 years later anytime I'm sick, even with just a cold. From the first time I had my period after the shot, I had excessive clotting and tiny scabs in the blood. My first, second, and fifth period after the shot were only 3 days long whereas my usual is 5 days. Some periods have been completely absent. I've started experiencing cramps, aching, and burning in my ovaries since the shot. All of these symptoms have persisted for three years. I began to experience increased anxiety and depression that has also persisted and worsened to the point that I've added more medications but have no relief. The depression and anxiety have worsened, and I've developed other cognitive issues like inability to focus and frequent confusion. This has rendered me unable to do the work I'd done in the past, and I'm currently on disability leave.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Burning sensation, Cognitive disorder, Condition aggravated, Confusional state
Clinical narrative: Within one minute after the shot I felt as though I'd faint. I became dizzy and thought I would pass out. I held onto a shelf to steady myself and breathed deeply for a few minutes until I no longer felt like fainting, but dizziness persisted for about 15-20 minutes. Within 8 hours I began to experience severe Covid symptoms (I'd had Covid twice before) that lasted two weeks. I had severe joint pain in my knees, elbows, ankles, and wrists that I'd never felt before. This pain appears still 3 years later anytime I'm sick, even with just a cold. From the first time I had my period after the shot, I had excessive clotting and tiny scabs in the blood. My first, second, and fifth period after the shot were only 3 days long whereas my usual is 5 days. Some periods have been completely absent. I've started experiencing cramps, aching, and burning in my ovaries since the shot. All of these symptoms have persisted for three years. I began to experience increased anxiety and depression that has also persisted and worsened to the point that I've added more medications but have no relief. The depression and anxiety have worsened, and I've developed other cognitive issues like inability to focus and frequent confusion. This has rendered me unable to do the work I'd done in the past, and I'm currently on disability leave.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Disability, Disturbance in attention, Dizziness, Hypomenorrhoea
Clinical narrative: Within one minute after the shot I felt as though I'd faint. I became dizzy and thought I would pass out. I held onto a shelf to steady myself and breathed deeply for a few minutes until I no longer felt like fainting, but dizziness persisted for about 15-20 minutes. Within 8 hours I began to experience severe Covid symptoms (I'd had Covid twice before) that lasted two weeks. I had severe joint pain in my knees, elbows, ankles, and wrists that I'd never felt before. This pain appears still 3 years later anytime I'm sick, even with just a cold. From the first time I had my period after the shot, I had excessive clotting and tiny scabs in the blood. My first, second, and fifth period after the shot were only 3 days long whereas my usual is 5 days. Some periods have been completely absent. I've started experiencing cramps, aching, and burning in my ovaries since the shot. All of these symptoms have persisted for three years. I began to experience increased anxiety and depression that has also persisted and worsened to the point that I've added more medications but have no relief. The depression and anxiety have worsened, and I've developed other cognitive issues like inability to focus and frequent confusion. This has rendered me unable to do the work I'd done in the past, and I'm currently on disability leave.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise, Muscle spasms, Nasopharyngitis, Scab
Clinical narrative: Within one minute after the shot I felt as though I'd faint. I became dizzy and thought I would pass out. I held onto a shelf to steady myself and breathed deeply for a few minutes until I no longer felt like fainting, but dizziness persisted for about 15-20 minutes. Within 8 hours I began to experience severe Covid symptoms (I'd had Covid twice before) that lasted two weeks. I had severe joint pain in my knees, elbows, ankles, and wrists that I'd never felt before. This pain appears still 3 years later anytime I'm sick, even with just a cold. From the first time I had my period after the shot, I had excessive clotting and tiny scabs in the blood. My first, second, and fifth period after the shot were only 3 days long whereas my usual is 5 days. Some periods have been completely absent. I've started experiencing cramps, aching, and burning in my ovaries since the shot. All of these symptoms have persisted for three years. I began to experience increased anxiety and depression that has also persisted and worsened to the point that I've added more medications but have no relief. The depression and anxiety have worsened, and I've developed other cognitive issues like inability to focus and frequent confusion. This has rendered me unable to do the work I'd done in the past, and I'm currently on disability leave.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Persistent cough.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: Pt got both flu and prevnar 20 immunization on 8/29/24. Pt came in today to let us know she developed intense body-wide itch about 1 day afterward and hives about 2 days afterward. Pt had flu before but no pneumococcal, so assumed it was caused by that. She went to the doctor who gave her a corticosteroid shot in office, direction to use benadryl, and an rx for prednisone (which she picked up today) to start in 2 days if the injection didn't have an effect, with direction to not get any more vaccinations unless he tells her to.  She said the itch is now mostly gone and the hives about 85% resolved. No other reaction was noted.   Upon further conversation, pt stated that she's had episodes of itch/hives about 3 other times over the past 6 months. Reviewof the pt's state vaccination showed that pt hasn't had any vaccinations since 11/2023. We gave the pt the  report to show her provider at her next appointment.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received two flu shots this season. First shot was given 8/9 and second shot was given 9/10.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: 9/7/24 5:30pm Received shot, arm immediately hurt badly (worse than any COVID, Flu, Shingles, Tetnus shot ever); 9/8/24 Upper arm very red, hard, & hot in area of shot (have never reacted like this to any type of shot); 9/9/24 Shot area began to itch (did not scratch it any); 9/9/24 Reported reaction in person to pharmacist who gave shot & she commented she's seen several people with same symptoms with this particular Covid shot but there is no reason for me to be concerned; I asked if it should be reported to Pfizer & pharmacist told me I could do so if I wanted to; 9/10/24 at 6:00pm No change with symptoms but all still present.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 9/7/24 5:30pm Received shot, arm immediately hurt badly (worse than any COVID, Flu, Shingles, Tetnus shot ever); 9/8/24 Upper arm very red, hard, & hot in area of shot (have never reacted like this to any type of shot); 9/9/24 Shot area began to itch (did not scratch it any); 9/9/24 Reported reaction in person to pharmacist who gave shot & she commented she's seen several people with same symptoms with this particular Covid shot but there is no reason for me to be concerned; I asked if it should be reported to Pfizer & pharmacist told me I could do so if I wanted to; 9/10/24 at 6:00pm No change with symptoms but all still present.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Several spots/skin lesions all over the body, especially on the arms and legs. No burning or itching associated with these marks. No treatment per the patient, just cosmetic in appearance and examined by his DR and believed to be due to this vaccine.
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administration error
Clinical narrative: vaccine administration error. no symptoms
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Pericarditis
Clinical narrative: Patient presented with constellation of symptoms including EKG abnormalities consistent with a diagnosis of acute pericarditis.  She was diagnosed on September 10.  We are treating her with NSAIDs.  There is no indication for admission to the hospital or ongoing monitoring.
Age: 65.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Cough, Swollen tongue
Clinical narrative: PATIENT REPORTED TONGUE SWELLING AND COUGH 4 HOURS AFTER RECEIVING VACCINATIONS. HE CALLED TO REPORT THE DAY AFTER THE INCIDENT OCCURED AFTER ALL SYMPTOMS RESOLVED. PATIENT STATES THAT HE DID NOT SEEK MEDICAL TREATMENT BECAUSE IT STARTED TO SUBSIDE. HE REPORTS ONLY TAKING IBUPROFEN FOR SYMPTOMS.  HE SAID THAT HE HAS HAD BOTH FLU AND COVID VACCINES IN COMBINATION BEFORE, BUT THIS WAS HIS FIRST TIME WITH THE HIGH-DOSE FLU VACCINE.
Age: 26.0
Sex: U
Vaccine: HPV9, PNC20
Symptoms: Dizziness, Hyperhidrosis, Tachycardia, Tachypnoea
Clinical narrative: 10 minutes following administration, patient became dizzy and lightheaded, mildly diaphoretic, mildly tachycardic, mildly tachypneic. Remained normotensive without respiratory distress. Physician deemed no need for epinephrine due to lack of hives or throat closure more concerning for anaphylaxis. However, due to lack of available medications to administer at clinic, patient was sent via EMS to ED.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Headache, Nausea, Oedema peripheral
Clinical narrative: strong headache, nausea, edema in lower legs
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Swollen arm, hot and red to the touch fever, said she was unable to move her arm. She has not seen a MD as of today, condition has improved.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: Atrial fibrillation requiring cardioversion in ER (9/9/24). On 9/7/24 and into 9/8/24 had severe vaccine reaction symptoms, with fever-like symptoms, exhaustion, muscle aches. This may have triggered the Atrial Fibrillation event that started during the night of 9/8 to 9/9.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Myalgia, Troponin
Clinical narrative: Atrial fibrillation requiring cardioversion in ER (9/9/24). On 9/7/24 and into 9/8/24 had severe vaccine reaction symptoms, with fever-like symptoms, exhaustion, muscle aches. This may have triggered the Atrial Fibrillation event that started during the night of 9/8 to 9/9.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Urticaria
Clinical narrative: Acute urticaria
Age: 61.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient stated that he experienced no adverse event from 2 of the same vaccine
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Pyrexia
Clinical narrative: First 24 hours was flu-like symptoms: fever, chills, sore arm, body pain. 2 to 4 days later, woke in middle of the night with bed spinning. 6 days later have full blown vertigo. Has not resolved with doctor's intervention or PT.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Vertigo
Clinical narrative: First 24 hours was flu-like symptoms: fever, chills, sore arm, body pain. 2 to 4 days later, woke in middle of the night with bed spinning. 6 days later have full blown vertigo. Has not resolved with doctor's intervention or PT.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure decreased, Loss of consciousness, Pulse absent
Clinical narrative: PATIENT LOST CONSCIOUSNESS 5-10 MINUTES AFTER RECEIVING BOOSTRIX VACCINE. THE BLOOD PRESSURE DROPPED TO VERY LOW LEVELS OF 67/47 AND COULD NOT FEEL THE PULSE. WE HAD TO CALL THE FIRST RESPONDERS TO HANDLE THE SITUATION IF IT GOT WORSE.  THE PATIENT RECOVERED JUST AS THE FIRST RESPONDERS ARRIVED AT THE SCENE AND LEFT HOME AFTER FEW MINUTES.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Pt stated they wound up in the hospital because of the Pfizer vaccine please call pt for any additional info
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Full blood count normal, Metabolic function test, Oedema
Clinical narrative: Approx 30hr post Vax had chills. In AM progressively worsening SQ edema and nonpuritic, erythematous rash on flexor surfaces of arms& legs and trunk.  Continued worsening edema especially all joints.  No relief w/ Tylenol.  On Tuesday, started course of NSAIDs with slight relief of pain but continued edema.  On Thurs9/5, started Prednisone 60/60/40/40/20 taper. Finally started noticing improvement in SQ edema &joint pain on 9/7 with marked improvement on 9/9.  Now with only small degree of edema and L sided edema > Right.  Rash resolved on 9/7.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: Approx 30hr post Vax had chills. In AM progressively worsening SQ edema and nonpuritic, erythematous rash on flexor surfaces of arms& legs and trunk.  Continued worsening edema especially all joints.  No relief w/ Tylenol.  On Tuesday, started course of NSAIDs with slight relief of pain but continued edema.  On Thurs9/5, started Prednisone 60/60/40/40/20 taper. Finally started noticing improvement in SQ edema &joint pain on 9/7 with marked improvement on 9/9.  Now with only small degree of edema and L sided edema > Right.  Rash resolved on 9/7.
Age: 19.0
Sex: F
Vaccine: FLUR4
Symptoms: Syncope
Clinical narrative: Asked patient if any reaction to previous flu vaccine, patinent claims no. Upon giving patient went shopping and fainted to the floor
Age: 18.0
Sex: F
Vaccine: FLUC4, MENB, MNQ
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: After receiving Bexsero, patient started to feel dizzy and nauseated.  She threw up shortly after.  About 10 minutes later, she felt better.  Pharmacist took blood pressure 110/86mmHg  HR95.  Pt sat for another 15 minutes and went home.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, and itchy at injection site. The redness spread out several inches.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Confusional state, Disorientation, Dizziness
Clinical narrative: Reported Symptoms: 10002391:ANGINAL PAIN; 10008479:CHEST PAIN; 10010300:CONFUSION; 10012703:DIAPHORESIS; 10013395:DISORIENTATION; 10013575:DIZZINESS; 10016558:FEVER; 10043071:TACHYCARDIA; Narrative: Other Relevant HX: Other: DISORIENTED; TACHYCARDIA; FEVER; DIAPHORESIS; CHEST PAIN
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Tachycardia
Clinical narrative: Reported Symptoms: 10002391:ANGINAL PAIN; 10008479:CHEST PAIN; 10010300:CONFUSION; 10012703:DIAPHORESIS; 10013395:DISORIENTATION; 10013575:DIZZINESS; 10016558:FEVER; 10043071:TACHYCARDIA; Narrative: Other Relevant HX: Other: DISORIENTED; TACHYCARDIA; FEVER; DIAPHORESIS; CHEST PAIN
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blister
Clinical narrative: Reported Symptoms: 10005216:BLISTERS; Narrative:  Other Relevant HX:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10046735:URTICARIA; Narrative: Patient presented to ED due to itching over her entire body that began 15 minutes after receiving the Pfizer COVID vaccine in the vaccination clinic. No complaints other than itching - some mild redness of her skin but denies SOB, wheezing, mouth swelling or tingling, hives, or welts. Patient administered dexamethasone, diphenhydramine, and famotidine in ED and given outpatient prescription for Epi-Pen and advised to take oral diphenhydramine as needed for itching. Other Relevant HX: Other: URTICARIA
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Erythema multiforme, Injection site bruising, Injection site erythema, Injection site rash
Clinical narrative: Reported Symptoms: 10015150:ERYTHEMA; 10015218:ERYTHEMA MULTIFORME; 10037844:RASH; 10042674:SWELLING; Narrative: Other Relevant HX: Note 6/20/24: Patient reports he got a shingles vaccine at his appt on 6/17. He reports it was painful for 3 days but the pain has subsided. States it has bruised up and become red and swollen with a rash around the injection site. Patient denies fever or vomiting. No previous vaccine reaction. States he has had shingles vaccine 10 years ago and did not have a reaction. Patient declines appt - he would just like a call back from team to discuss. Follow up note 6/20/24: They stated that patient's arm was hurting for about 3 days after the injection which they figured was normal but now there is a bruise and it is red and swollen under the injection site. Told patient that it's not recommended to get the second shingles vaccine since he had this type of reaction. will have MSA cancel appointment on 8/19/24. Also will list as an allergy. Told patient and wife to keep an eye on the area and if it gets worse to please let us know so we can get him in for an appointment. Patient and wife voiced good understanding. Nothing else follows in regards to vaccine/ADR from vaccine. Other: SWELLING; ERYTHEMA; RASH
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity, Swelling
Clinical narrative: Reported Symptoms: 10015150:ERYTHEMA; 10015218:ERYTHEMA MULTIFORME; 10037844:RASH; 10042674:SWELLING; Narrative: Other Relevant HX: Note 6/20/24: Patient reports he got a shingles vaccine at his appt on 6/17. He reports it was painful for 3 days but the pain has subsided. States it has bruised up and become red and swollen with a rash around the injection site. Patient denies fever or vomiting. No previous vaccine reaction. States he has had shingles vaccine 10 years ago and did not have a reaction. Patient declines appt - he would just like a call back from team to discuss. Follow up note 6/20/24: They stated that patient's arm was hurting for about 3 days after the injection which they figured was normal but now there is a bruise and it is red and swollen under the injection site. Told patient that it's not recommended to get the second shingles vaccine since he had this type of reaction. will have MSA cancel appointment on 8/19/24. Also will list as an allergy. Told patient and wife to keep an eye on the area and if it gets worse to please let us know so we can get him in for an appointment. Patient and wife voiced good understanding. Nothing else follows in regards to vaccine/ADR from vaccine. Other: SWELLING; ERYTHEMA; RASH
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema, Skin disorder
Clinical narrative: Reported Symptoms: 10014210:EDEMA; Narrative: Patient had received 4 doses of the COVID-19 (MODERNA) vaccine previously before his 5th dose on 3/7/24. Patient reported he has a mushy sac near his right elbow. Other Relevant HX: Other: EDEMA
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Sedation
Clinical narrative: Reported Symptoms:  10015150: ERYTHEMA; 10039897:SEDATION; Narrative: Other Relevant HX: Other: erythema
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Hyponatraemia, Pulmonary embolism
Clinical narrative: Reported Symptoms: 10021038:HYPONATREMIA; 10037377:PULMONARY EMBOLISM; 10043642:THROMBOSIS VENOUS DEEP; Narrative: Patient has received 7 COVID vaccines and on the 8th COVID vaccine in March 2024, the patient was hospitalized on 6 March 2024 with a bilateral pulmonary embolism, DVT, and hyponatremia. The patient was started on apixaban. The patient was discharged in stable condition and instructed that he should not receive any additional COVID Boosters. Other Relevant HX: Other: DVT, PE, Hyponatremia
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Reported Symptoms: 10042772:SYNCOPE; Narrative: 06/22/23: Vaccine given (1 dose). 6/17/24 PCP note: "pt had had a reaction to the shingles vaccine that put him "out.". He does not want any further shingles vaccine." Other Relevant HX: Other: Syncope
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Chills, Cough, Feeling hot
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10008531:CHILLS; 10011232:COUGHING; 10023222:JOINT PAIN; 10039177:RIGORS; 10042772:SYNCOPE; Narrative: Patient received first Zoster recombinant vaccine on 04/05/24. During his follow-up visit for the second dose on 06/04/24, patient reported a number of different health problems that started when he took his first dose of the zoster vaccination. Patient reported middle lower back pain and subacute dry cough, since receiving the zoster vaccination. The day prior to this visit, his second dose of the Zoster vaccine was given, and patient reported general malaise, diffuse joint pain, rigors, chills, and warmth. His provider prescribed an epi pen, azithromycin only if cough worsens, celecoxib 200 mg prn, and administered a Toradol 60 mg shot in clinic for joint pain. Of note, patient reported when asked that he has a history of tobacco use where he quit 8 years ago. Currently, smokes about 5-6 cigars in a year, and uses vape pen daily. Other Relevant HX: Other: JOINT PAIN, rigors, chills
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Pain
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10008531:CHILLS; 10011232:COUGHING; 10023222:JOINT PAIN; 10039177:RIGORS; 10042772:SYNCOPE; Narrative: Patient received first Zoster recombinant vaccine on 04/05/24. During his follow-up visit for the second dose on 06/04/24, patient reported a number of different health problems that started when he took his first dose of the zoster vaccination. Patient reported middle lower back pain and subacute dry cough, since receiving the zoster vaccination. The day prior to this visit, his second dose of the Zoster vaccine was given, and patient reported general malaise, diffuse joint pain, rigors, chills, and warmth. His provider prescribed an epi pen, azithromycin only if cough worsens, celecoxib 200 mg prn, and administered a Toradol 60 mg shot in clinic for joint pain. Of note, patient reported when asked that he has a history of tobacco use where he quit 8 years ago. Currently, smokes about 5-6 cigars in a year, and uses vape pen daily. Other Relevant HX: Other: JOINT PAIN, rigors, chills