chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Eye swelling, Pyrexia, Urticaria
Clinical narrative: fever, facial hives and eye swelling approximately 5 minutes after vaccine administration. Patient given Benadryl and Ibuprofen. Observed for 20 minutes after medication administration with resolution of facial hives and eye swelling. One hour later, fever resolved per parent report over the phone.
Age: 52.0
Sex: F
Vaccine: HEPAB, IPV
Symptoms: Arthralgia, Mobility decreased, Pain
Clinical narrative: Pt complains of increasing pain and decreased movement of R shoulder, with symptoms starting to worsen 48 hours after injection.  No redness, swelling, or rash at site.  States that it has been painful as she moves her shoulder from body and when she raises her arm above her head.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: PT STATED THAT WITHIN ABOUT 2 HOURS AFTER RECEIVING THE SHINGRIX IMMUNIZATION, HER UPPER ARM STARTED HURTING A LOT ABOUT 2 INCHES BELOW THE  AREA OF THE SHOT. SHE WAS ALSO SWEATING AND HAD SIGNIFICANT NAUSEA.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Well on the same day she vomited, had a fever I feel like that COVID 19 vaccine made her sick, and for me that's not right
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Induration, Injection site erythema, Injection site warmth, Pyrexia, Swelling
Clinical narrative: induration, swelling, warmth and redness of injection site, fever up to 101F
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: During the administration of the Pfizer COVID-19 vaccine, it was noted that the vaccine was diluted with 1.8 mL of diluent instead of the recommended 1.1 mL.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dry skin
Clinical narrative: At around 10:30 am on 01/24/2025 patient approached Team (PHN Team)  - (RN, PHN and RN, PHN and requested a Hepatitis A vaccine. RN, PHN reviewed patient eligibility and confirmed vaccine history in the Immunization Registry database. Patient denied having a history of allergies or adverse reactions to vaccines. Patient denied syncope after receiving vaccines in the past. At  10:55 am, RN, PHN administered Havrix (Lot # 772YT, Expiration date 9/23/2025) in the right deltoid, intramuscularly. At 11:00 am patient reported she ?felt dizzy?. Patient appeared sitting calmly in the chair, RN, PHN provided patient with a juice box. RN, PHN, offered to lie patient down on the yoga mat. Patient denied moving and requested to stay sitting. Patient began drinking the juice box. Patient's skin was dry and appropriate color for Ethinicy.  At 11:05 am patient gave verbal consent for RN, PHN to measure vitals. Vital signs measured as follows: blood pressure 102/68 mm Hg, heart rate 75 beats per minute, respiratory rate 18 breaths per minute, oxygen saturation 98%. Patient stated she was "feeling better". At 11:08 am patient reported symptom had resolved completely. PHN, educated patient about risk for syncope with vaccinations. PHN, referred patient to primary care clinic for follow up and future vaccines.  Patient stood up at 11:10 am to go to her appointment at clinic. Patient denied any return of symptoms and walked away with a steady gait and balance to the next resource tent.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose on accident. Patient did not recall getting the whole series in 2020.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report an AE regarding the PROQUAD vaccine. HCP stated that an improperly stored PROQUAD was administered to a patient. HCP provided limited pertinent information and demographic data. Permission to follow-up with the HCP is unspecifie; No additional AE/PQC reported; This spontaneous report was received from a physician and refers to a 4-year-old male.  No information on patient's medical history, current conditions and concomitant medication was provided.  On 30-DEC-2024, the patient was vaccinated with improperly stored dose (temperature excursion) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) Subcutaneous Injection (albumin status: rHA) lot #Y009108, expiration date: 06-NOV-2025, administered subcutaneously in the left arm for prophylaxis (strength, exact dose, and dose number were not provided) (product storage error). The vaccine was determined to be viable. No additional adverse events and product quality complaints was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE. No PQC.; HCP reports patient did not get her second GARDASIL 9 dose until today, 1/17/2025 and her first dose was "years ago, like 11 years".; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender.   The patient's pertinent medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date (reported as "years ago, like 11 years"), the patient was vaccinated with the 1st dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) Injection administered as prophylaxis (strength, lot #, expiry date, route of administration and anatomical location were not provided) and then on 17-JAN-2025, the patient received the second dose of  of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe also administered as prophylaxis, lot number: 1965044, expiration date: 07-JAN-2026 (strength, route of administration and anatomical location were not provided) (inappropriate schedule of product administration). No additional adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Nurse confirmed the patient involved has not reported any medical concerns or symptoms after being administered the expired dose of PROQUAD.; Nurse calling with a report of an adverse event regarding an expired dose of PROQUAD that was administered to a patient.  Nurse stated that the dose of PROQUAD had a labeled expiration date of 1/6/2025 and was administered to the patient on 1/20/2025; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JAN-2025, an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5 ml / two dose series, lot #X018729, expiration date: 06-JAN-2025 (administered for prophylaxis, strength, and route of administration were not provided) was administered to the patient (Expired product administered). Operator of device was health professional. Nurse confirmed the patient involved had not reported any medical concerns or symptoms after being administered the expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (No adverse event). No additional information provided.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC.; Pharmacy student called and reported an adult patient who received two doses of GARDASIL 9 in 2018 and received a third dose of GARDASIL 9 in 2024.; This spontaneous report was received from a pharmacy student and refers to a 26-year-old adult patient with unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown dates in 2018, the patient received first dose and second dose (two doses) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strengths, doses, lots #, expiry dates, and routes of administration were not provided).  On an unknown date in 2024, the patient received a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). No additional information was known by reporter. No additional adverse event (AE) (No adverse event).  Lots is being requested and will be submitted if received.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; HCP called to report inadvertent administration of an expired dose of VAQTA to a pediatric patient.  Expiration date of 12/26/2024, administered on 1/20/2025.  Potency supported by Post Expiry Memo.  See Request case 02738592.  No adverse effects wer; This spontaneous report was received from a nurse referring to a 8-year-old female patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 20-JAN-2025, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # X020849, expiration date 26-DEC-2024, 0.5 milliliter (route of administration not reported) for prophylaxis (expired product administered). No adverse event was reported.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP called to report inadvertent administration of an expired dose of VAQTA to an adult patient.; Dose .5ML; This spontaneous report was received from a nurse regarding a 36-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.  On 20-JAN-2025, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, 0.5 milliliter, administered for prophylaxis (lot number X020849 has been verified to be a valid number for hepatitis a vaccine, inactivated [VAQTA], expiration date 26-DEC-2024) (anatomical site of injection and route of administration were not provided) (Expired product administered, Incorrect dose administered). No additional adverse event was reported for the patient.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; HCP calling to report that patient inadvertently received expired dose of GARDASIL 9 on 1/20/2025 that expired on 1/8/2025. Per post expiry sheet, product is supported. No adverse effects reported. No additional AE. No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 20-JAN-2025 the patient was inadvertently vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # W029724, expiration date 08-JAN-2025, Single Dose; strength, route were not reported) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; HCP called to report a Temperature Excursion  on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te; This spontaneous report was received from Other Health Professional and refers to a.  The patient's medical history was not reported. The patient's concurrent conditions included  medication dilution. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown).   On 06-DEC-2024, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #Y006522, expiration date: 25-MAR-2026, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, the patient experienced No additional adverse event. On 06-DEC-2024, the patient experienced HCP called to report a Temperature Excursion  on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te. At the time of reporting, the outcome of the event HCP called to report a Temperature Excursion  on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te was not known, the outcome of the event No additional adverse event was not known. The action taken with VARIVAX regarding HCP called to report a Temperature Excursion  on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te was reported as Not Applicable. The action taken with VARIVAX regarding No additional adverse event was reported as Not Applicable.
Sex: F
Vaccine: RSV
Symptoms: Dysstasia, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: intermittent muscle pains /leg muscle pain; weakness in legs; difficult to climb stairs/rise from sitting position; No longer have muscle pains in arms and body; This non-serious case was reported by a consumer and described the occurrence of myalgia of lower extremities in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included hypertension (Treated with Ramipril and Carvedilol), transient ischemic attack (Patient had Transient ischaemic attack in 1999), blood cholesterol increased (Treated with Crestor) and cardiovascular risk (Treated with Jardiance). Concomitant products included carvedilol, ramipril, clopidogrel bisulfate (Plavix), rosuvastatin calcium (Crestor) and empagliflozin (Jardiance).   On 23-OCT-2024, the patient received Arexvy. On 28-OCT-2024, 5 days after receiving Arexvy, the patient experienced myalgia of lower extremities (Verbatim: intermittent muscle pains /leg muscle pain), lower extremities weakness of (Verbatim: weakness in legs), activities of daily living impaired (Verbatim: difficult to climb stairs/rise from sitting position) and generalized muscle aches (Verbatim: No longer have muscle pains in arms and body). The outcome of the myalgia of lower extremities, lower extremities weakness of and activities of daily living impaired were not resolved and the outcome of the generalized muscle aches was resolved.   It was unknown if the reporter considered the myalgia of lower extremities, lower extremities weakness of, activities of daily living impaired and generalized muscle aches to be related to Arexvy.     It was unknown if the company considered the myalgia of lower extremities, lower extremities weakness of, activities of daily living impaired and generalized muscle aches to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-DEC-2024 A 87 year female patient received Arexvy vaccine and experienced intermittent muscle pain and weakness in leg. The patient no longer had muscle pains in arms and body but leg pains still persist which was severe at time, worse at night.  Leg weakness still persists making it difficult to climb stairs and rise from sitting position. The patient reported that the symptoms was not treated. The patient current condition includes hypertension, Transient ischaemic attack, High cholesterol and Cardiovascular risk
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: put me out for a full day; This non-serious case was reported by a consumer and described the occurrence of feeling abnormal in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: put me out for a full day). The outcome of the feeling abnormal was resolved (duration 1 day).   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.     It was unknown if the company considered the feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-DEC-2024 The patient self-reported this case for himself. The patient said that he just got his first Shingles vaccine and that put him out for a full day.  He did not want to get the full real shingles. He got to get the second vaccine too, and further said everyone else should too.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient just finished shots about a year ago and like a month ago came down with shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Mobility decreased
Clinical narrative: couldnt move my arm; also felt sick for; wiped me out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: couldnt move my arm), feeling unwell (Verbatim: also felt sick for) and fatigue (Verbatim: wiped me out). The outcome of the mobility decreased was resolved and the outcome of the feeling unwell and fatigue were not reported.   It was unknown if the reporter considered the mobility decreased, feeling unwell and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the mobility decreased, feeling unwell and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JAN-2025 This case was reported by a patient via interactive digital media. The- patient received shingles vaccine and it was wiped out, could not move my arm for days also felt sick for that same period of time. The patient said it was a piece of cake compared to getting shingles, get vaccinated.; Sender's Comments:  US-GSK-US2025AMR009137:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Occupational exposure to product, Product complaint, Syringe issue
Clinical narrative: solution squirted on face; Vial leak; Pharmaceutical product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received Herpes zoster (Shingrix) (batch number K72R2, expiry date 24-JAN-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure via skin contact with product (Verbatim: solution squirted on face), product leakage (Verbatim: Vial leak) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, product leakage and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 27-DEC-2024 The nurse stated she attempted to insert needle into adjuvant component of Shingrix and the needle bounced off the rubber stopper and the solution squirted onto the health care professional face, which led occupational exposure via skin contact with product.. The reporter something was wrong with the stopper on that vial as she used another adjuvant and was able to successfully withdraw the medication. The patient did receive the dose of Shingrix using another adjuvant vial.  The nurse refused to send a picture stating she does not have time to do so. The information received from QA department on 22-JAN-2025 GlaxoSmithKline had completed its investigation for the quality defect that was reported.  The investigation included a review of the defect trends and testing of the retained samples and a review of the related production records, all of which demonstrated that the reported batch was produced in compliance with the applicable procedures and met all required specifications. Nothing atypical was identified while the product was under GlaxoSmithKline control which would explain the reported quality defect. The GlaxoSmithKline considered the complaint that was the object of this report as unsubstantiated.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: incomplete course of vaccination; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose in 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-DEC-2024 Reporter stated that patient received Shingrix vaccine one dose only in 2022 and asked if patient require 1 or 2 doses now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient received only the liquid adjuvant portion of Shingrix; patient received only the liquid adjuvant portion of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number GA99K) for prophylaxis.   On 15-JAN-2025, the patient received Shingrix. On 15-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-JAN-2025 The nurse reported that a patient received only the liquid adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered At the time of reporting a repeat dose had not yet been administered.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis.  The batch number was not reported. Company was unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced deadly vaccine. After taking COVID-19 shot. (dose series is 1) The action taken with janssen covid-19 vaccine was not applicable.  The outcome of deadly vaccine was not reported.  This report was associated with product quality complaints: Product Complaint 90000347962; 90000347798.  Investigation Results: Undetermined. Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. Although a definitive root cause could not be determined for this case, this complaint record will be included in the periodic product quality complaint trending. Verified signals are assessed as per TV-WI-14276. No further action is required at this time.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers.   No concomitant medications were reported.  On an unspecified date, the patient experienced deadly vaccine. (dose series is 1).   The action taken with janssen covid-19 vaccine was not applicable.  The outcome of deadly vaccine was not reported.  This report was associated with product quality complaints: Product Complaint 90000347798; 90000347962.  Investigation Results: Undetermined, Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information. Although a definitive root cause could not be determined for this case, this complaint record will be included in the periodic product quality complaint trending. Verified signals are assessed as per TV-WI-14276. No further action is required at this time.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series:1, for covid-19 prophylaxis.  No concomitant medications were reported.  On an unspecified date, the patient experienced deadly vaccine.  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of deadly vaccine was not reported.  This report was associated with a product quality complaint: Product Complaint 90000347797.  Investigation Results: Undetermined-Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: deadly vaccine; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid 19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced deadly vaccine. (dose series 1)  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of deadly vaccine was not reported.  This report was associated with a product quality complaint: Product Complaint 90000347801.  Investigation Results: Undermined: Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: DEADLY VACCINE; This spontaneous report received from a consumer by a company representative concerned a patient of unspecified age and sex. Additional reporter noted as Lawyer. Document was received in the form Legal Summons and Complaint and EZ report. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.   The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers.   No concomitant medications were reported.  On an unspecified date, the patient experienced deadly vaccine. after taking COVID-19 shot. (dose series is 1).   The action taken with janssen covid-19 vaccine was not applicable.  The outcome of deadly vaccine was not reported.  This report was associated with a product quality complaint: Product Complaint 90000347802.  Investigation Results: Undetermined: Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information.  This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: deadly vaccine; This spontaneous report received from a lawyer concerned a patient of unspecified age and sex. Document was received in the form Legal Summons and Complaint and EZ report.  The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch or lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced deadly vaccine. (dose series is 1).   The action taken with janssen covid-19 vaccine was not applicable.  The outcome of deadly vaccine was not reported.  This report was associated with a product quality complaint: Product Complaint 90000347799.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: he felt "flu-ish" for a day or two; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (he felt "flu-ish" for a day or two) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (he felt "flu-ish" for a day or two). At the time of the report, INFLUENZA LIKE ILLNESS (he felt "flu-ish" for a day or two) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-467516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-467516:Reporter's case
Age: 67.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: COVID-19
Clinical narrative: he got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (he got COVID) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    The patient's past medical history included Stroke (25 years ago). Concurrent medical conditions included Disability.   On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In May 2024, the patient experienced COVID-19 (he got COVID). At the time of the report, COVID-19 (he got COVID) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that patient was supposed to get a second dose of the 2023 booster which he had never heard about.  On May-2024, patient got COVID and it lasted about a week. There was lots of coughing , and his mucus was abnormal, it was clear and bubbly. He could breathe okay but he knew something was wrong. He stated he self-isolated for 5 days after he returned from his trip.He could not self-test as he is disabled and that he could only use one arm.  Treatment information was not provided.
Sex: U
Vaccine: RSV
Symptoms: Needle issue
Clinical narrative: once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe; needle broke off the diluent syringe; This is a spontaneous report received from an Other HCP from product quality group, Program ID:  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe"; NEEDLE ISSUE (non-serious), outcome "unknown", described as "needle broke off the diluent syringe".  Causality for "once the pharmacy tried to reconstitute it, it broke/something went wrong with the component of the diluent syringe" and "needle broke off the diluent syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: Has a caller on the line who is a pharmacy intern calling about Abrysvo vaccine and stated that once the pharmacy tried to reconstitute it, it broke. She is reporting that and requests replacement product. The presentation is the diluent and the lyophilized antigen component. She is not fully aware what happened regarding it breaking but the pharmacist told her that while trying to reconstitute it, the needle broke off the diluent syringe and she has no manufacturer name or lot number to provide for the needle. Caller clarified she is now not sure if the needle broke or if something went wrong with the component of the diluent syringe. Carton/box: lot number KC7884, expiry date Sep2025, NDC 0069034401; Antigen vial: lot number KC7884, expiry date Oct2025, NDC 0069020701, and it says lyophilized antigen component. Diluent syringe: lot number HM8389, expiry date Sep2025, NDC 0069025001. Vial adaptor: Asks is that the white portion and she sees the connector piece on the diluent and antigen vial. Confirmed no patient involvement.
Age: 24.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain
Clinical narrative: vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread and it was very painful; it was red, it is all at the injection site/ redness has started to spread; This is a spontaneous report received from a Consumer or other non HCP.  A 24-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Jan2025 as dose 1, single (Lot number: 5469) at the age of 24 years, in arm for maternal immunisation. The patient was 34 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 34 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Jan2025, outcome "not recovered", described as "vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread and it was very painful"; VACCINATION SITE ERYTHEMA (non-serious) with onset Jan2025, outcome "not recovered", described as "it was red, it is all at the injection site/ redness has started to spread". The events "vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread and it was very painful" and "it was red, it is all at the injection site/ redness has started to spread" required emergency room visit. It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema.  Causality for "vaccine hurt pretty bad as got it/arm is really sore, all at the injection site/starting to spread and it was very painful" and "it was red, it is all at the injection site/ redness has started to spread" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Clinical course: office manager called to reported: they gave the patient Abrysvo for maternal and the vaccine hurt pretty bad as she got it, but Sunday she called the doctor's office to report and she has pictures of everything. Arm was really sore, and it was red, it was all at the injection site but it was red and it got worse over the days. So, she ended up going to the ER, because of the soreness and the redness. She said it looked like, she was the patient told her own, told her off the doctor, on Sunday. It was a patient, a pregnant patient came in on 02Jan2025. A 24-year-old female, on 02Jan2025 to get, she was 34 weeks pregnant, she got a gestational age. She got a Abrysvo vaccine and then she said that it got her really bad when she got the vaccine, at the time but later on, a couple of days later she called the office on Sunday and left them a message saying that she was in pain, that she went to the ER because of soreness and the redness has started to spread, from just being at the injection site and it was just starting to spread and it was very painful. The event stared within a next couple of days. Patient went to the emergency room and did not know what they gave her.
Sex: U
Vaccine: PNC20
Symptoms: Drug reaction with eosinophilia and systemic symptoms
Clinical narrative: DRESS; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (medically significant), outcome "unknown", described as "DRESS". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Scan, Vaccination failure
Clinical narrative: Has gotten Covid three times/Third time patient had to be in the emergency room about seven hours; Has gotten Covid three times/Third time patient had to be in the emergency room about seven hours; This is a spontaneous report received from a Physician.  A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "aortic dissection", start date: 23Dec2015 (unspecified if ongoing), notes: medical emergency, genetic, probably thirty people in family would have had it, is a disabling feature of patient.; "memory issues", start date: Mar2016 (unspecified if ongoing), notes: memory issues came three months around that, then became more progressive, right now patient is stable. There were no concomitant medications. Vaccination history included: comirnaty 12 plus (DOSE 7, SINGLE), administration date: 03Jul2024, for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 3, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 4, SINGLE), for Covid-19 Immunization; Moderna bvln bstr (DOSE 5, SINGLE, Moderna BVLN BSTR), for Covid-19 Immunization; Spikevax 12 plus (DOSE 6, SINGLE, Spikevax 12 plus), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Has gotten Covid three times/Third time patient had to be in the emergency room about seven hours". The patient underwent the following laboratory tests and procedures: Scan: Unknown results. BNT162b2 omicron (kp.2) administered on Sep2024 or Oct2024 and hospitalization occurred for two nights or for four nights.; Sender's Comments: Based on the information currently available, a lack of efficacy with 62b2 omicron (kp.2) in this patient cannot be completely excluded.  The patient's predispositions such as old age, underlying disease/ concomitant medications leading to immunity insufficiency may contribute to suboptimal response after vaccination.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient might have received an expired dose with no reported adverse event; Initial information received on 17-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and gender patient to whom received an expired dose of IPV (Vero) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient might have received a expired dose unknown dose of suspect IPV (VERO) Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization (circumstance or information capable of leading to medication error) (same day latency).   Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Blood test, Body temperature decreased, Dizziness, Electrocardiogram, Eye movement disorder
Clinical narrative: all was normal for the first 6 days, slight swelling and redness at injection site. Woke in the morning of the 7th day with dizziness and when I opened my eyes they were jumping back and forth  and stopped after about 30 -45 seconds,and my palpitations which I have been dealing with for a while now were bad and my temp was very low, 93.  I went to the Er and they found nothing obviously wrong. I had not even considered it had been my vaccination as my arm looked totally clear the night before and there was no redness or swelling, so I did not think of mentioning  it. On arriving home I ran my hand up my arm and discovered it was hot and upon inspection discovered it swollen and bright red! It is better today, the swelling has gone way down and the redness is subsiding. I have been applying topical Benadryl to the site. I do believe it was a late reaction to the vaccine. Unexpected and scary. I have not had a reaction to other vaccinations in the past but am concerened about future vaccinations