chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a dose of VAXELIS was given to a 5 year old patient.; This non-serious spontaneous safety report with reference number: 02729137 (interaction number: 02729135 ) was received by MSD, on 03-JAN-2025 and forwarded to agency on 03-JAN-2025 from a medical assistant.  Due to the nature of the event, the causality between the event "a dose of VAXELIS was given to a 5 year old patient" and Vaxelis was not applicable.   Case was considered as off-label use due to the reported event of patient being administered Vaxelis at age of 5 years.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called to report TE where ROTATEQ, VAXELIS and VAXNEUVANCE were administered to one patient.; This non-serious spontaneous safety report, with reference number 02731387 (interaction number: 02731358), was received by partner on 07-JAN-2025 and forwarded to UBC on 08-JAN-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called to report TE where ROTATEQ, VAXELIS and VAXNEUVANCE were administered to one patient' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; an inappropriate use due to medical assistant inadvertently administered VAXELIS instead of Varivax; This non-serious spontaneous safety report, with reference number 2025SA011036, was received by partner on 10-JAN-2025 and forwarded to UBC on 13-JAN-2025 from the physician.  Due to the nature of the event, the causality between the events 'an inappropriate use due to medical assistant inadvertently administered VAXELIS instead of Varivax, Extra dose administered' and Vaxelis was not applicable.  Further information is expected.  Significant follow-up was received by partner on 24-JAN-2025 and forwarded to UBC on 24-JAN-2025 from the physician in the United States. The case remained as non-serious, with concomitant vaccinations provided.  Due to the nature of the event, the causality between the events 'an inappropriate use due to medical assistant inadvertently administered VAXELIS instead of Varivax, Extra dose administered' and Vaxelis was not applicable.  Further information is not expected.
Vaccine: DTPPVHBHPB
Symptoms: Inflammation, Lymphadenitis, Malaise, Pyrexia
Clinical narrative: malaise; Lymphadatitis; high inflammation; high fever; This non-serious spontaneous safety report, with reference number 02733834 (interaction number: 02733830), was received by partner on 10-JAN-2025 and forwarded to UBC on 13-JAN-2025 from physician.   The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'high fever, malaise, lymphadenitis, and high inflammation'.  Further information is not expected.  Non-significant follow-up information was received via email on 27-JAN-2025, from a physician.  The case is maintained as non-serious.   Further information is not expected.
Vaccine: DTPPVHBHPB
Symptoms: Inflammation, Lymphadenitis, Malaise, Pyrexia
Clinical narrative: Malaise; Lymphadenitis; High inflammation; High fever; This non-serious spontaneous safety report, with reference number 02733835 (interaction number: 02733830), was received by partner on 10-JAN-2025 and forwarded to UBC on 13-JAN-2025 from physician.   The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'high fever, malaise, lymphadatitis, and high inflammation'.  Further information is expected.
Sex: M
Vaccine: DTAP, DTAPIPVHIB, DTPPVHBHPB, HIBV, IPV, MMR
Symptoms: Extra dose administered
Clinical narrative: it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got confused whether to inject VAXELIS or PENTACEL; Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and 16-JAN-2025; Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel; This non-serious spontaneous safety report was received by partner on 14-JAN-2025 and forwarded to UBC on 16-JAN-2025 from a healthcare professional.  Due to the nature of the event, the causality assessment between Vaxelis and the events were not applicable.  Further information is expected.  Non-significant follow-up information was received by the partner on 27-JAN-2025 and forwarded to UBC on 29-JAN-2025, from other health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got confused whether to inject VAXELIS or PENTACEL", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and 16-JAN-2025", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel" and Vaxelis was not applicable.    Further information is not expected.  Significant follow-up information was received by the partner on 27-JAN-2025 and forwarded to UBC on 28-JAN-2025, from other health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got confused whether to inject VAXELIS or PENTACEL", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and 16-JAN-2025", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel" and Vaxelis was not applicable.    Further information is not expected.  Significant follow-up information was received by the partner on 30-JAN-2025 and forwarded to UBC on 30-JAN-2025, from other health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event "it was supposed to be PENTACEL to be administered, the assistant who administered the vaccines got confused whether to inject VAXELIS or PENTACEL", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and 16-JAN-2025", "Patient received an extra dose of DTaP-IPV-Hib components from the VAXELIS and Pentacel" and Vaxelis was not applicable.    Further information is not expected.
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child received a dose of VAXELIS at 2 months old and another dose at 4 months old. At 6 months old the child received the PEDIARIX vaccine; This non-serious spontaneous safety report, with reference number 02737956 (interaction number: 02737889), was received by the partner on 17-JAN-2025 and forwarded to UBC on 17-JAN-2025, from other health professional.   Due to the nature of the event, the causality between the event "Child received a dose of VAXELIS at 2 months old and another dose at 4 months old. At 6 months old the child received the PEDIARIX vaccine" and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: an inappropriate use due to VAXELIS inadvertently given to a patient instead of a Flu Shot; 9-year-old patient; This non-serious spontaneous, safety report was received by partner, on 31-JAN-2025 and forwarded to UBC on 03-FEB-2025 from a healthcare professional.  This case is considered off-label use, due to product use in unapproved population, as the patient is 9 years old.   The reporter did not provide an assessment of the causal relationship between Vaxelis and "an inappropriate use due to VAXELIS inadvertently given to a patient instead of a Flu Shot".  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: Friday vaccinated 15-month old VAXELIS instead of DAPTACEL Inquiry Comments:; This non-serious spontaneous safety report, with reference number 2025SA034914, was received by partner on 03-FEB-2025 and forwarded to UBC on 04-FEB-2025 from other health professional.  Due to the nature of the event, the causality between the event 'Friday vaccinated 15-month old VAXELIS instead of DAPTACEL' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received an early dose of VAXELIS and is wondering about potential side effects; This non-serious spontaneous safety report, with reference number 2025SA036455, was received by partner on 04-FEB-2025 and forwarded to UBC on 05-FEB-2025 from other health professional.  Off-label classification was added due to an early dose of Vaxelis being administered (inappropriate schedule of vaccine).  Due to the nature of the event, the causality between the events 'Patient received an early dose of VAXELIS and is wondering about potential side effects' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, FLU3
Symptoms: Wrong product administered
Clinical narrative: Was supposed to get VAXELIS but she was administered FLUZONE (pf) instead.; This non-serious spontaneous safety report, with reference number 2025SA039561, was received by partner on 07-FEB-2025 and forwarded to agency on 10-FEB-2025 from other health professional.  Due to the nature of the event, the causality between the events 'was suppose to get VAXELIS but she was administered FLUZONE (pf) instead' and Vaxelis was not applicable.  Further information is not expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: administration of VAXELIS instead of Quadracel; patient receiving extra doses of Hib and  hepatitis B antigens.; This non-serious spontaneous safety report, with reference number 2025SA043502 (Inquiry number 02407940), was received by partner on 10-FEB-2025 and forwarded to UBC on 12-FEB-2025 from other health professional.  Due to the nature of the events, the causality between the events 'administration of VAXELIS instead of Quadracel' and 'patient receiving extra doses of Hib and  hepatitis B antigens.' and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Syringe issue, Underdose
Clinical narrative: Patient didn't receive a complete dose of vaccine.; HCP stated that while administering injection to patient, contents of syringe 'sprayed out everywhere' between luer lock and needle attachment.; This non-serious spontaneous safety report, with reference number 02751876 (interaction number: 02751871), was received by partner on 11-FEB-2025 and forwarded to UBC on 11-FEB-2025 from other health professional. Additional information was received by partner on 12-FEB-2025 and forwarded to UBC on 13-FEB-2025 from other health professional.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events, 'Patient didn't receive a complete dose of vaccine' and 'HCP stated that while administering injection to patient, contents of syringe 'sprayed out everywhere' between luer lock and needle attachment'.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, HEP
Symptoms: Extra dose administered
Clinical narrative: administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day; inadvertently administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day; This serious spontaneous safety report with MSD reference number #02752914was received by the partner on 12-FEB-2025 and forwarded to UBC on 13-FEB-2025, from a healthcare professional.   Due to the nature of the event, the causal relationship between Vaxelis and the reported event of "administered both the RECOMBIVAX HB and VAXELIS Vaccines on the same day" was not applicable.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received 2 vaccinations of VAXELIS in the same visit.; This serious spontaneous safety report with MSD reference number #002754092 was received by the partner on 14-FEB-2025 and forwarded to UBC on 14-FEB-2025, from a healthcare professional.   Due to the nature of the event, the causal relationship between Vaxelis and the reported event of "patient inadvertently received 2 vaccinations of VAXELIS in the same visit" was not applicable.  Further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy lymph gland, Diffuse large B-cell lymphoma
Clinical narrative: Diffuse Large B cell lymphoma
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Blood immunoglobulin A, Blood immunoglobulin G, Blood uric acid
Clinical narrative: after receiving my COVID vaccine series 2 events happened.  One I had vaginal bleeding for 6 weeks, post menopausal.  The second is that in 2023 I developed Rheumatoid Arthritis.  I do not know if there is a link but I think it should be reported.  Thanks.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, Complement factor C3, Complement factor C4, Double stranded DNA antibody, HLA marker study
Clinical narrative: after receiving my COVID vaccine series 2 events happened.  One I had vaginal bleeding for 6 weeks, post menopausal.  The second is that in 2023 I developed Rheumatoid Arthritis.  I do not know if there is a link but I think it should be reported.  Thanks.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immunology test, Postmenopausal haemorrhage, Red blood cell sedimentation rate, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: after receiving my COVID vaccine series 2 events happened.  One I had vaginal bleeding for 6 weeks, post menopausal.  The second is that in 2023 I developed Rheumatoid Arthritis.  I do not know if there is a link but I think it should be reported.  Thanks.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: redness right deltoid injection site; itching right deltoid injection site; soreness right deltoid injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 06-FEB-2025, the patient received Arexvy .5 ml. On 06-FEB-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness right deltoid injection site), injection site itching (Verbatim: itching right deltoid injection site) and injection site muscle pain (Verbatim: soreness right deltoid injection site). The outcome of the injection site erythema, injection site itching and injection site muscle pain were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching and injection site muscle pain to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site itching and injection site muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-FEB-2025 The reporter reported there was no other conditions provided. Pharmacy did not provide lot number.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First Vaccination - Missed Second; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (on 09-JUL-2024 received 1st dose).   On an unknown date, the patient did not receive Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: First Vaccination - Missed Second). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 17-FEB-2025 The patient received 1st dose of Shingles vaccine. Till the time of reporting the patient had not received the second dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea; This non-serious case was reported by a consumer and described the occurrence of nausea in a 55-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy).   On 21-FEB-2025, the patient received Shingles vaccine. On 23-FEB-2025, 2 days after receiving Shingles vaccine, the patient experienced nausea (Verbatim: Nausea). The outcome of the nausea was not resolved.   It was unknown if the reporter considered the nausea to be related to Shingles vaccine.     It was unknown if the company considered the nausea to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-FEB-2025 The patient self-reported this case  The patient received Shingles vaccine and experienced nausea and was not treated
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This non-serious case was reported by a consumer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu-like symptoms). The outcome of the influenza-like symptoms was resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2025 The reporter reported that patient received the Shingrix vaccine and had flu-like symptoms for couple of days. The other was Zostavax but it was supposed to be discontinued.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: dose 1 given was a pediatric dose; dose 1 given was a pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis.   On 25-JUL-2024, the patient received the 1st dose of Engerix B pediatric. On 25-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: dose 1 given was a pediatric dose) and adult use of a child product (Verbatim: dose 1 given was a pediatric dose). The outcome of the underdose and adult use of a child product were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-JAN-2025 The pharmacist reported that 21 year old female patient was in pharmacy requesting third dose of Engerix-B series. The first two doses were administered at another facility. Upon looking at the records, dose 1 was given was a pediatric dose which led to underdose and adult use of a child product. On 27th August 2024, dose 2 was given was an adult dose. The patient was 20 years old at the time of both doses. At the time of call, the pharmacist had not yet administered a third dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood disorder, Cerebral thrombosis, Cerebrovascular accident, Death
Clinical narrative: developed atrial fibrillation/atrial fibrillation worsened; stroke; blood clot was found in her brain; having blood issues after her first vaccine; we lost her; she started retaining water 2 weeks before we lost her; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (we lost her), ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened), CEREBROVASCULAR ACCIDENT (stroke) and CEREBRAL THROMBOSIS (blood clot was found in her brain) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In August 2022, the patient experienced FLUID RETENTION (she started retaining water 2 weeks before we lost her). On an unknown date, the patient experienced ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), CEREBRAL THROMBOSIS (blood clot was found in her brain) (seriousness criterion medically significant) and BLOOD DISORDER (having blood issues after her first vaccine). The patient died on 14-Sep-2022. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened), CEREBROVASCULAR ACCIDENT (stroke), CEREBRAL THROMBOSIS (blood clot was found in her brain), FLUID RETENTION (she started retaining water 2 weeks before we lost her) and BLOOD DISORDER (having blood issues after her first vaccine) outcome was unknown.            Concomitant medication was not reported. Patient started having blood issues after her first vaccine. After her second vaccine she developed atrial fibrillation issues and was rushed to the emergency room for a stroke, and a blood clot was found in her brain. After the third vaccine the atrial fibrillation worsened, and she started retaining water 2 weeks before her death. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: we lost her
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention
Clinical narrative: developed atrial fibrillation/atrial fibrillation worsened; stroke; blood clot was found in her brain; having blood issues after her first vaccine; we lost her; she started retaining water 2 weeks before we lost her; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (we lost her), ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened), CEREBROVASCULAR ACCIDENT (stroke) and CEREBRAL THROMBOSIS (blood clot was found in her brain) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In August 2022, the patient experienced FLUID RETENTION (she started retaining water 2 weeks before we lost her). On an unknown date, the patient experienced ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), CEREBRAL THROMBOSIS (blood clot was found in her brain) (seriousness criterion medically significant) and BLOOD DISORDER (having blood issues after her first vaccine). The patient died on 14-Sep-2022. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened), CEREBROVASCULAR ACCIDENT (stroke), CEREBRAL THROMBOSIS (blood clot was found in her brain), FLUID RETENTION (she started retaining water 2 weeks before we lost her) and BLOOD DISORDER (having blood issues after her first vaccine) outcome was unknown.            Concomitant medication was not reported. Patient started having blood issues after her first vaccine. After her second vaccine she developed atrial fibrillation issues and was rushed to the emergency room for a stroke, and a blood clot was found in her brain. After the third vaccine the atrial fibrillation worsened, and she started retaining water 2 weeks before her death. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: we lost her
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: administered a 4th dose of the vaccine on 10/21/2024 while they were 9 months old. Nurse confirmed the patient adhered to the 3 dose series of VAXELIS, but were inadvertently administered a 4th dose.; administered a 4th dose of the vaccine on 10/21/2024 while they were 9 months old. Nurse confirmed the patient adhered to the 3 dose series of VAXELIS, but were inadvertently administered a 4th dose.; administered a 4th dose of the vaccine on 10/21/2024 while they were 9 months old. Nurse confirmed the patient adhered to the 3 dose series of VAXELIS, but were inadvertently administered a 4th dose.; This non-serious spontaneous safety report, with reference number 02739314 (interaction number: 02739305), was received by partner on 21-JAN-2025 and forwarded to agency on 21-JAN-2025 from other health professional.   Off-label classification was added due to Vaxelis being administered to a 9-month-old patient.  Due to the nature of the event, the causality between the events 'administered a 4th dose of the vaccine on 10/21/2024 while they were 9 months old. Nurse confirmed the patient adhered to the 3 dose series of VAXELIS but were inadvertently administered a 4th dose' and Vaxelis was not applicable.  Further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac amyloidosis, Carpal tunnel syndrome, Magnetic resonance imaging heart, Muscle injury, Tendon rupture
Clinical narrative: Patient received Pfizer covid 19 vaccine doses on 2/5/21 and 2/26/21. Following those Pfizer Covid 19 doses patient experienced bilateral bicep tears, bilateral ham [INVALID]te, and bilateral carpal tunnel syndromes. Patient was concerned about possible amyloidosis following these symptoms as muscle and carpal tunnel manifestations are known complications of amyloidosis. In August of 2023 (~18 months follow covid vaccine doses) he was diagnosed with cardiac amyloidosis. Case reports of covid 19 vaccine induced amyloidosis are available in published literature.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient states they have arm tingling and numbness radiating through their shoulder into their fingers on the arm the vaccine was administered. it has been over 4 months since then and it still comes and goes, has not gotten better.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Lymphadenopathy, Neoplasm
Clinical narrative: I am a 56 y/o woman with a history of Type 1 Diabetes (LADA) Lupus, Stage 3A Kidney Disease, Non-Alcoholic Cirrhosis of the Liver and Breast Cancer. After receiving my second Moderna vaccination for Covid 19, (that made me so ill I spent close to a week in bed) I noticed that the lymph nodes on the underneath side of my arms from my armpits down and my groin, became swollen and dense feeling. I put it down to being chronically sick. However, when I mentioned it to my endocrinologist literally a few years later, she ordered a CT scan. It showed lymph nodes of various sizes with flow, having fatty hilums. ranging from 0.5 to 2.5 cm The lymph nodes have times when they slightly reduced in size only to come back and get larger. They currently feel the largest they have even been. Especially in the armpit next to the breast where I had my lumpectomy and radiation treatment for breast cancer. I have an MRI scheduled for 2/25/25. It is for a couple of different things, but my endocrinologist will be looking at the state of my lymph nodes. Having had cancer and still having several tumors is what is concerning to my doctor. There lines of swollen lymph nodes never existed prior to the Moderna Covid vaccination, which I received approximately 4/21 from the pharmacy at our local store. Although I have many co-morbid conditions, permanently swollen lymph nodes were never one of them. I would like to know if the Moderna vaccination indeed caused this, and will this do me further harm given my medical history of cancer and currently having multiple tumors? Knowledge is power and staying on top of my medical conditions is imperative. I'm sure that is understandable. Thank you for your time and consideration  We will find out after the 25th if there are additional changes to the lymph nodes and the existing tumors.
Sex: F
Vaccine: RSV
Symptoms: Stevens-Johnson syndrome
Clinical narrative: I received a GSK RSV vaccine and had a late onset reaction that turned out to be SJS I went to Urgent Care Clinic and no test was performed.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Alpha-1 antitrypsin deficiency, Chronic lymphocytic leukaemia
Clinical narrative: Since taking the first two Covid vaccines, I have been diagnosed with alpha 1 antitrypsen deficiency (no family history) and chronic lymphocytic leukemia. Perfectly health prior to Covid.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dysphagia, Facial paralysis, Hypoaesthesia, Mastication disorder, Paraesthesia
Clinical narrative: The evening after the vaccine, pt. began to feel tingling sensation in left cheek and jaw, the following day at school his friends noted his "uneven facies, left side drooping", mom then noted significant facial differences when she saw him after school that day and took him straight to ER. There they performed a physical exam and labs. His vital signs and labs were normal, face was still numb on left side, weak with inability to smile and fully close left eye, mild difficulty chewing and swallowing. Per mother's report the providers at the ER did not feel that imaging was necessary. He was sent home on a oral steroid wean. When seen in PCP office on 2/22/25, weakness and numbness per
Age: 1.0
Sex: M
Vaccine: MMRV, PNC20, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None reported at this time
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Magnetic resonance imaging
Clinical narrative: Complete loss of taste and smell for more than two years.  Smell and taste never went back to normal.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear congestion, Persistent postural-perceptual dizziness, Tinnitus, Vertigo positional
Clinical narrative: Fullness in ears happened within an hour after first shot.  Tinnitus started a few days later and came and went at first becoming more frequent and the volume increasing after the second shot one month later.   It didn't come and go after that, it just remained.  I don't remember a change after the 3rd shot but the tinnitus is now permanent and loud.   I am now dealing with BPPV and PPPD and constant tinnitus.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Excessive cerumen production, Tinnitus
Clinical narrative: Noticeable ringing in ears.  Thought I had a wax plug so went to doctor to have ears checked out.  During visit had a hearing exam.  Noted to technician that I had ringing in my ears.  Having worked in an industry that demanded hearing tests yearly, I knew that driving, which I had to drive 60 miles to appointment, may cause some hearing distortion.  The doctor was also told of the ringing in the ears but no mention was made except for ear leaning.  After visit and continuing on till today, the tinnitus remains.  There is no relief able to be provided. As mentioned, I wore hearing protection every day and my hearing tests performed provided no abnormal impacts to hearing.  The tinnitus did not occur during my working career.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Urticaria
Clinical narrative: 400pm developed localized left arm only urticaria and itching
Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: patient received a second dose of vaccine after having received a dose less than 2 years ago. vaccines given too close together
Age: 46.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Fatigue, Flushing, Product preparation error, Rash, Vision blurred
Clinical narrative: After administration of MMR vaccine subcutaneous to the left upper arm, noticed the MMR vaccine had been reconstituted with the HEPLISAV-B vaccine instead of the sterile diluent. Subcutaneous injection was given at 11:30 AM. At 11:45 AM began c/o feeling flushed, slight blurry vision, rash noticed on bilateral sides of neck and on upper right scapula. Denied any symptoms of Anaphylaxis. 11:56 AM VS: BP 151/95 Pulse 75 Resp 16 O2 sat 98%. 12:05 PM Diphenhydramine 50 mg IM. 1225 rash and flushing has disappeared. Pt is feeling drowsy from the Benadryl injection. VSS. Monitored pt until daughter came to clinic to take her home. Pt denies any symptoms upon leaving with the exception of tiredness. Pt ambulated with assistance of RN to daughter's vehicle. Advised pt and daughter if patient were to experience any anaphylactic symptoms such as difficulty breathing, lip or tongue swelling or any other emergent conditions to report to the nearest emergency room for evaluation. Pt vitals upon clinic discharge at 1405 were: BP 134/83 heart rate 78, respirations 16, 02 sat 98%.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This dose of the influenza vaccine was administered on 1/30/2025. Unfortunately, the nurse administering the vaccine was unaware that the patient received a previous dose of the influenza vaccine on 1/02/2025. The patient had no symptoms, treatment was not required, and there were no adverse outcomes.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave an expired MMR vaccine to child. MMR vaccine expired on 02/08/2025 and it was given on 02/20/2025.  No adverse reactions noted.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Rash, Swelling face
Clinical narrative: Pt had severe reaction post vaccination for about 3 weeks. Their arm was red and swollen, then about 2-3 weeks after vaccination she developed a red rash on her face with some swelling.
Age: 15.0
Sex: F
Vaccine: FLU3, HEP, HEPA, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave an expired MMR vaccine to child. MMR vaccine expired on 02/08/2025 and it was given on 02/20/2025. No adverse reactions noted.
Age: 27.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Fall, Head injury, Syncope
Clinical narrative: PT FAINTED 2-3 MINS AFTER ADMINISTRATION, HE WAS WALKING AWAY THEN FELL AND HIT HIS HEAD ON THE GROUND.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Fatigue began 2/20/2025 and lasted through 2/21/2025. Reported fever in the middle of the night 2/20/25-2/21/25 that broke by morning, never took temperature. Reported waking up with a lima bean sized swollen lymph node on the morning of 2/21/25. Lymph node remains swollen but decreasing on 2/25/2025.
Age: 21.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions.
Age: 25.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Extra dose administered, Myalgia, Pyrexia, Urticaria
Clinical narrative: Patient reported experiencing fever, chills, hives, and myalgia approximately 48-72 hr after receiving a third Shingrix dose. Previous doses 1&2 of Shingrix were administered in 2022.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, IPV, MENB, MMR, MNQ, TDAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave an expired MMR vaccine to a child. the MMR vaccine expired 02/08/2025 and it was given on 02/20/2025. No adverse reactions noted.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reaction
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Out of range temperature for refrigerator. No adverse reactions
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Employee given Heplisav-B on 12/4/24 and then again on 12/10/24. No adverse event.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Myocardial infarction, Thrombosis
Clinical narrative: clot developed causing fatal heart attack
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Pain, Pyrexia, Swelling face
Clinical narrative: Hives all over body, difficulty breathing, swelling of face, fever, body aches and chills
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives all over body, difficulty breathing, swelling of face, fever, body aches and chills
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Gait inability, Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: Muscles stiffness, pain, weakness in RUE and RLE. Sevre enough unable to ambulate.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after the vaccine was given that the refrigerator that it was kept in was out of temperature range.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine from a fridge that was out of temperature range at that time.
Age: 41.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after the vaccine was given that the refrigerator that it was kept in was out of temperature range.
Age: 37.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cardiac monitoring, Dysstasia, Hyporesponsive to stimuli, Seizure, Unresponsive to stimuli
Clinical narrative: My son had a seizure and was unresponsive the saturday 2/22/25  after having his Dtap vaccine. We took him to the ER and he was responsive by the time we got there but still sluggish and had trouble standing.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given Hepatitis A vaccine too early.  2nd dose in series due 6/5/2024, was accidentally given today 2/25/2025.  Father made aware.  He gave verbal understanding.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Given wrong vaccine was supposed to be given Hep- B
Age: 72.0
Sex: F
Vaccine: PNC21, RSV
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: PATIENT CALLED US ON 2/25/25 TO LET US KNOW THAT SHE HAD A REACTION TO THE VACCINE GIVEN TO HER ON HER RIGHT ARM. THE VACCINE WAS CAPVAXIVE. SHE RECEIVED THE VACCINE ON 02/20/25 AND HAD INJECTION SITE REACTION TO THAT VACCINE AND THE AREXVY ON THE LEFT ARM AS WELL. ON 2/21/25 SHE NOTICED THAT SHE HAD REDNESS, RASH, WARMTH AND BURNING THAT REACHED PAST THE INJECTION SITE. PATIENT SAYS THAT IT IS COVERING FROM HER SHOULDER TO ELBOW. SHE SAYS THAT IT FEELS SIMILAR TO THE FEELING OF HAVING A SHINGLES VIRUS INFECTION. SHE HAS NOT BEEN DIAGNOSED WITH SHINGLES BUT I TOLD HER TO FOLLOW UP WITH HER PRIMARY DOCTOR TO GET A DIAGNOSIS IF NESSESARY. SHE HAS NOTICED THAT THE ITCHING AND SWELLING ARE NO LONGER SPREADING AND IS LOCALIZED TO THE SHOULDER TO ELBOW AREA. SHE HAS TRIED TO APPLY BENADRYL CREAM WHICH SEEMS TO HAVE HELPED A LITTLE BIT BUT IS STILL EXPERIENCING DISCOMFORT. I LET HER KNOW SHE MAY ALSO TRY CORTISONE CREAM AND ANTIHISTAMINES. SHE SAID SHE IS UNABLE TO USE ANTIHISTAMINES BECAUSE SHE DOESN'T REACT WELL TO THEM. I TOLD HER SHE CAN ALSO ICE THE AREA TO HELP WITH THE IRRITATION. SHE IS GOING TO SET UP A FOLLOW UP WITH HER DOCTOR TO GET AN EVALUATION.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 1.58
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No symptoms reported by patient
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: It was discovered after vaccine was given, that the refrigerator it was kept in was out of temperature range at the time the vaccine was administered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dysgeusia, Dyspnoea, Fatigue, Injected limb mobility decreased
Clinical narrative: I got the shot in my LT deltoid 01/05, Tuesday afternoon. Within minutes had nerve pain from LT shoulder to elbow. Resolved over 10-15 min. By that night I noticed some soreness in my axilla. Wednesday my left rib cage hurt so bad I couldn't take a deep breath for 2 days. I couldn't sit normally in a chair because I felt my insides were pushing up on my lungs and ribs. I couldn't lay flat. I had increased sinus congestion, everything tasted funny, things that weren't normally spicy were. Tested negative for covid again that Thursday night. Woke up in a pool of sweat on Friday and then the right side of my throat swelled up within minutes about 30 min after I got to work. Literally within a few minutes at work it felt like I had tonsillitis, and my right side of my throat was tender. The only reason I didn't freak out more was because I was amongst the CRNAs and was in the room across from me. Exhausted more every day from the night after getting it until I woke up from a nap Friday afternoon/evening. Everything was gone except the sore throat. That resolved on Sunday.  Noticed residual left deltoid muscle weakness 01/11 when I couldn't hold up a foot to prep. Unable to raise arm where elbow is horizontal to shoulder. Unable to lift more than a couple pounds until 2 weeks later when I could lift 5 lbs. Took 2 weeks to get motor function back to that arm.  was giving it a week before sending me to therapy in hopes of using stim therapy that they use for nerve palsy. I spoke to PA and PA and PA about it as well. Also noticed insidious onset of LT hand aching pain at the MPJ of the middle finger and RT DIPJ of the pinky (5th) finger. This pain was intermittent with movement.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Musculoskeletal chest pain, Neuralgia, Night sweats, Oropharyngeal pain
Clinical narrative: I got the shot in my LT deltoid 01/05, Tuesday afternoon. Within minutes had nerve pain from LT shoulder to elbow. Resolved over 10-15 min. By that night I noticed some soreness in my axilla. Wednesday my left rib cage hurt so bad I couldn't take a deep breath for 2 days. I couldn't sit normally in a chair because I felt my insides were pushing up on my lungs and ribs. I couldn't lay flat. I had increased sinus congestion, everything tasted funny, things that weren't normally spicy were. Tested negative for covid again that Thursday night. Woke up in a pool of sweat on Friday and then the right side of my throat swelled up within minutes about 30 min after I got to work. Literally within a few minutes at work it felt like I had tonsillitis, and my right side of my throat was tender. The only reason I didn't freak out more was because I was amongst the CRNAs and was in the room across from me. Exhausted more every day from the night after getting it until I woke up from a nap Friday afternoon/evening. Everything was gone except the sore throat. That resolved on Sunday.  Noticed residual left deltoid muscle weakness 01/11 when I couldn't hold up a foot to prep. Unable to raise arm where elbow is horizontal to shoulder. Unable to lift more than a couple pounds until 2 weeks later when I could lift 5 lbs. Took 2 weeks to get motor function back to that arm.  was giving it a week before sending me to therapy in hopes of using stim therapy that they use for nerve palsy. I spoke to PA and PA and PA about it as well. Also noticed insidious onset of LT hand aching pain at the MPJ of the middle finger and RT DIPJ of the pinky (5th) finger. This pain was intermittent with movement.