chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: severe vertigo; dizzy; couldn't walk; couldn't see, vision was really blurry; Rear occipital stroke; This is a spontaneous report received from an Other HCP.  A 33-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (disability, medically significant) with onset 25Mar2023, outcome "recovering", described as "Rear occipital stroke"; VISION BLURRED (non-serious) with onset Jun2023, outcome "recovering", described as "couldn't see, vision was really blurry"; GAIT DISTURBANCE (non-serious) with onset Jun2023, outcome "recovering", described as "couldn't walk"; DIZZINESS (non-serious) with onset Jun2023, outcome "recovering", described as "dizzy"; VERTIGO (non-serious) with onset Jun2023, outcome "recovering", described as "severe vertigo". The patient underwent the following laboratory tests and procedures: numerous tests and studies: Unknown results.  Clinical course: Patient initially suffered two cryptogenic strokes back in April, caller then checked and clarified and confirmed the two strokes were rear occipital strokes. First stroke occurred 25Mar2023, second stroke occurred 05Jun2023. Called to report, has gone through numerous tests and studies, doctors cannot figure out what caused. With first stroke, fainted, lost consciousness, was out for over a minute. With second stroke had severe vertigo, became dizzy, was dizzy for about three weeks nonstop, couldn't walk, was in bed two and a half weeks, couldn't see, vision was really blurry, wasn't stable, couldn't focus on anything for about a month. Would say disabling as well, hard to say whether life threatening, hard to say if life threatening, any time you have a stroke is life threatening.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The association between the event rear occipital stroke with BNT162b2 NOS can not be fully excluded based on the limited information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a reaction with Dupixent and the second COVID vaccine / headaches; This is a spontaneous report received from a Consumer or other non HCP from License Party.  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Lot number: 4F483A, Expiration Date: 31Aug2026) for covid-19 immunisation; dupilumab (DUPIXENT), as 300 mg qow (every other week; strength: 3000mg/2ml)) subcutaneous for dermatitis atopic. The patient's relevant medical history included: "Arthritis" (ongoing); "Osteoporosis" (ongoing); "D.farinae mite extract" (unspecified if ongoing); "illness" (unspecified if ongoing). Concomitant medication(s) included: PROLIA; METHOTREXATE; ATORVASTATIN CALCIUM; PAXLOVID taken for covid-19 treatment; ALBUTEROL SULFATE HFA; KETOCONAZOLE; INCRUSE ELLIPTA; METOPROLOL SUCCINATE; METHYLPREDNISOLONE. Past drug history included: Bupropion hcl, reaction(s): "Drug allergies: Bupropion"; Wellbutrin sr, reaction(s): "allergic to Wellbutrin SR". Vaccination history included: Covid-19 vaccine (dose 1; unknown manufacturer), for covid-19 immunization. The following information was reported: HEADACHE (hospitalization), outcome "unknown", described as "had a reaction with Dupixent and the second COVID vaccine / headaches". The action taken for dupilumab was unknown.  Clinical course:  On an unknown date, the patient started taking dupilumab solution for injection at a dose of 300 mg QOW (every other week) subcutaneously with strength of 3000mg/2ml delivered via prefilled pen for dermatitis atopic. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur. Reportedly, patient had a reaction with DUPIXENT and the second covid vaccine that put her in the hospital (adverse drug reaction; onset and latency: unknown). She had an injection of methylprednisone yesterday and she was aware that there's drug interactions between that and the Prolia. She was also prescribed methotrexate and it's concerned about drug interaction as well. Patient Prolia therapy stated she did not want to take anymore. Stated she was not fully informed by her doctor of the side effects of the Prolia also concerned with drug interactions she has read online about. Stated the Prolia caused joint pain, and she already had arthritis. Also believed there is a contraindication to using Prolia with a methylprednisone injection she received last week and her methotrexate. Upon follow-up, patient reported arthritis and headaches (headache; onset date and latency: unknown) (batch number: 4F483A and expiry date on 31Aug2026) no additional details.   SUSPECT PRODUCT is under agreement with BIONTECH SE.
Sex: U
Vaccine: FLU3
Symptoms: Feeling abnormal
Clinical narrative: feeling so bad; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a Consumer/ Non-Healthcare Professional.  This case involves an unknown age / gender patient who was feeling so bad after receiving influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization).   Information on the batch number was requested corresponding to the one at time of event occurrence.  On an unknown date the patient feeling so bad (feeling abnormal) (unknown latency) following the administration of influenza USP TRIVAL A-B high dose subvirion vaccine.  Reportedly, no additional information or specific symptoms were shared.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 8.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inappropriate use due to inadvertently administering pentacel rather than tenivac with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a Other health professional.  This case involves, a 8 years old male patient who received inappropriate use due to inadvertently administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] rather than Tenivac with no reported adverse event.  The patient's past medical treatment included Pediarix on 11-May-2017 with at 10 months of age. The patient's past medical history, vaccination(s) and family history were not provided.   On 20-Nov-2024, the patient who received inappropriate use due to inadvertently administered 0.5 ml dose (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UK044AA, expiry date: 31-Aug-2025) (unknown strength) via intramuscular route in the right deltoid for immunization rather than Tenivac with no reported adverse event (wrong product administered) (latency-same day).  Reportedly, Nurse practitioner stated that patient to receive Tenivac as part of his catch-up immunization schedule on 05-Nov-2024, but he was inadvertently administered Pentacel instead. His vaccine schedule was as follows:11-May-2017, at 10 months of age; 05-Sep-2024, at 8 years of age and 20-Nov-2024 - Pentacel (DTaPIPV-Hib) instead of Tenivac (Td).  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.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHib was administered with sterile water instead of saline with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age/gender patient to whom HIB (PRP/T) VACCINE [ACT-HIB] was administered with sterile water instead of saline with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (dose, strength, lot, expiry and route: unknown) with sterile water instead of saline with no reported adverse event (product preparation error) (latency same day)  in unknown administration site for immunization.  Information on batch number and expiry 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.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Adacel was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom had administered Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: unknown, expiry date: 01-Feb-2026, lot 3CA17C1) via unknown route in unknown administration site as immunization and was mixed with 0.5 ml of sterile diluent and administered to a patient in error with no reported adverse event (product preparation error) (same day latency).   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.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: One febrile seizure was reported 14 days after dose 4 of PCV20; the seizure was considered not related to PCV20, but possibly related to the measles, mumps, and rubella or varicella vaccine; Literature Report:  This literature marketed report has been received from the authors of the published article and refers to an infant of unspecified gender and age.   The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On unspecified date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) formulation as default: injection, or varicella virus vaccine live (Oka/Merck) (VARIVAX) formulation as default: injection (strength, dose, frequency, route of administration, vaccination scheme, site of vaccination, lot #, and expiration date were not provided) as a prophylaxis.   On unspecified date, the patient experienced a febrile seizure. At the reporting time, the outcome of the event was not provided.   The causal relationship between suspect vaccine with the event was considered as related (possibly related).    A copy of the published article is attached as further documentation of the patient's experience.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP reports that PROQUAD was inadvertently administered after suffering from a Temperaturre excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided.  On 18-DEC-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (rHA) injection, for prophylaxis, 0.5 milliliter per series, lot number Y013574 which has been verified t be valid, expiration date not reported but upon internal review established as 03-FEB-2026 (strength, route of administration and anatomical location not reported); and sterile diluent (MERCK STERILE DILUENT) solution for injection (strength, indication, dose, lot number, expiration date, route of administration and anatomical site not provided).  On the same date, the reported stated that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection was inadvertently administered after suffering from a temperature excursion, the product reached -11.6 degree celcius but previous excursions could not be confirmed, the product was out of range for 3 hours 5 minutes and 0 seconds but previous excursions could not be confirmed (Improper storage of product in use). No symptomatic adverse events were reported.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; swelling at the injection site; This is a spontaneous report received from a Nurse from medical information team.  A 27-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Jan2025 as dose 1, single (Batch/Lot number: unknown), in right arm for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 18Jan2025, outcome "not recovered", described as "swelling at the injection site"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 18Jan2025, outcome "not recovered" and all described as "the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy". Therapeutic measures were taken as a result of vaccination site warmth, vaccination site erythema, vaccination site inflammation, vaccination site pain, vaccination site pruritus, vaccination site swelling. Additional information: Patient was treated with Benadryl but didn't help. Patient was asking for advise. Patient was advised by the reporter to use cold compresses, continuous Benadryl as needed or she could switch to Zyrtec.
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth
Clinical narrative: the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy; swelling at the injection site; This is a spontaneous report received from a Nurse from medical information team.  A 27-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 16Jan2025 as dose 1, single (Batch/Lot number: unknown), in right arm for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 18Jan2025, outcome "not recovered", described as "swelling at the injection site"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INFLAMMATION (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 18Jan2025, outcome "not recovered" and all described as "the area where the vaccine was given was warm, red, and inflamed and it was also painful and itchy". Therapeutic measures were taken as a result of vaccination site warmth, vaccination site erythema, vaccination site inflammation, vaccination site pain, vaccination site pruritus, vaccination site swelling. Additional information: Patient was treated with Benadryl but didn't help. Patient was asking for advise. Patient was advised by the reporter to use cold compresses, continuous Benadryl as needed or she could switch to Zyrtec.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Condition aggravated, Weight decreased
Clinical narrative: Lost taste; Lost smell; Lost a lot of weight/ it was worse now; Lost a lot of weight/ it was worse now; This is a spontaneous report received from a Consumer or other non HCP.  An 88-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 29Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 88 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "lost a lot of weight" (unspecified if ongoing), notes: beginning past 2, 3 years. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; JANUVIA [SITAGLIPTIN PHOSPHATE] taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: Apr2021, when the patient was 85 years old, for covid-19 immunization. The following information was reported: AGEUSIA (non-serious), outcome "unknown", described as "Lost taste"; ANOSMIA (non-serious), outcome "unknown", described as "Lost smell"; WEIGHT DECREASED (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "Lost a lot of weight/ it was worse now".  Additional Information: The patient thought she had adverse events from  the Pfizer vaccine. The patient had had it from the beginning like past 2, 3 years, she had been going there with this, in updates and follow up. The first one was in Apr2021 and the last one was on 29Oct2024. The patient did not know the time of vaccination, she thought it was noon 11, 12 or 1 o'clock, she was not sure. The patient could not tell the specific day, it gradually happened over time, and it was worse now, she had lost a lot of weight.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Cardiac disorder, Suicide threat
Clinical narrative: I will need to get assisted suicide.; clogged arteries in my penis; heart issues; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUICIDE THREAT (medically significant), outcome "unknown", described as "I will need to get assisted suicide."; ARTERIAL OCCLUSIVE DISEASE (non-serious), outcome "unknown", described as "clogged arteries in my penis"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart issues".  Clinical course: The patient reported that :You guys caused clogged arteries in my penis. He has been to every single hospital and been to research hospitals and now has heart issues and clogged veins in his  penis from the Vaccine. The patient also stated" At just 19 years old you ruined my life. I am 22 now. I will need to get assisted suicide"  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Angioedema, Limb injury, Peripheral swelling
Clinical narrative: Angioedema; anaphylaxis; bumped her arm; Initial information received on 20-Jan-2025 regarding an unsolicited valid  serious case received from a consumer/non-health care professional.  This case involves a 70 years old female patient who had angioedema, anaphylaxis and bumped her arm after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Ona n unknown date in November 2024, the patient received a unknown dose of suspect Influenza Quadrival A-B High Dose Hv Vaccine lot U8161CA via intramuscular route in the left arm for Immunization (strength, formulation, expiry date was unknown).  On an unknown date the patient developed angioedema, anaphylaxis (anaphylactic reaction) and bumped her arm (peripheral swelling) (unknown latency) following the administration of Influenza Quadrival A-B High Dose Hv Vaccine.  Reportedly "She is not sure if she got the flu vaccine at that location in the past. ."  Action taken was not applicable for all the events.  It was not reported if the patient received a corrective treatment for the events (Angioedema, bumped her arm, anaphylaxis).  At time of reporting, the outcome was Unknown for the events.  Seriousness Criteria : Medically significant for the events angioedema and anaphylactic reaction.; Sender's Comments: Sanofi Company Comment dated 23-Jan-2025 : This case involves a 70-year-old female patient who had angioedema, anaphylaxis after receiving Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent].Further information regarding Past medical history, concurrent condition, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 0.33
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE NP was administered to a 4-month old patient with no reported adverse event; Initial information received on 21-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves, a 4 months old and unknown gender patient was administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect patient was administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (unknown strength, dosage, expiry date, batch number and route) via unknown administration site for Influenza with no reported adverse event (off label use) (latency- same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Caller stated the patient was accidentally given a flu shot and wasn't supposed to receive it until 6 months old.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Patient received 2 doses instead of 1, we did not know she had already received the vaccine. First one given on 02/22/24 and second one given 01/23/25. Patient has had no complaints other than a sore arm.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a  thjrd dose of Shingrix that was not necessary. No adverse reactions noted
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Decreased appetite, Injection site rash, Pyrexia
Clinical narrative: She has been crying non stop for over 3 hours, is developing a rash on her left thigh by the injection site, has not been taking her bottle, she has a fever of 101
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site pain, Pain
Clinical narrative: 1/27/25 Employee contacted Employee Health to report she has had a constant dull Lt upper arm and arm pit pain since her flu shot which was given on 12/23/24. She reports it becomes more intense when she lifts her arm. The employee was referred to be evaluated.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Feeling hot, Injection site bruising, Injection site erythema, Lethargy, Pain
Clinical narrative: patient had the vaccine on 01-07-25, noticed the reaction  started on 01-09-25. patient  experienced swollen arm, stinging, felt hot, sensitive to the touch, lethargic, injection site had red ring , about 5 days later, noticed bruising (size of large chicken egg) , patient iced the injection site, felt  a little better , 20 days later, site still has signs of bruise mark, with redness, but not much swelling, no more lethargy, still sensitive to touch
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: patient had the vaccine on 01-07-25, noticed the reaction  started on 01-09-25. patient  experienced swollen arm, stinging, felt hot, sensitive to the touch, lethargic, injection site had red ring , about 5 days later, noticed bruising (size of large chicken egg) , patient iced the injection site, felt  a little better , 20 days later, site still has signs of bruise mark, with redness, but not much swelling, no more lethargy, still sensitive to touch
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vitreous detachment
Clinical narrative: Posterior Vitrious Detachment (PVD)
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Administered fluarix. A couple hours later, patient came back stating wanted COVID vaccine
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram normal, Male reproductive tract disorder, Palpitations, Sperm concentration zero, Spermatozoa progressive motility decreased
Clinical narrative: Sometime between June of 2021, and early 2022, Moderna vaccination resulted in permanent damage to my reproductive system. Tests done in 2022 and 2023 have shown that there are no sperm cells seen in the samples. Before vaccination, semen tests (done in 2015 and June 2021) have shown normal amount of motile sperm cells. The detailed timeline of semen tests performed is shown on the next page. There were no other events or problems (no health problems, no injuries) that would explain that sperm cells stopped generating in my reproductive system, pointing to vaccination as the reason of the problem.  (See next page) Timeline of tests done for semen analysis before and after vaccination:  Oct 20, 2023   Lab test of semen  no sperm cells seen  Feb 17, 2023 -  test of semen  no sperm cells seen Feb 10, 2023   test of semen  no sperm cells seen    During 2022  self-tests with microscope, seen gradual decrease of moving sperm cell numbers, and moving cells seen not on every try Dec 12, 2021  Moderna 60H21A mRNA booster June 29, 2021  Lab test of semen and count  normal results and good motility (12x10^6) May 16, 2021  Moderna 014C21A mRNA vaccination Apr 18, 2021  Moderna 046B21A mRNA vaccination Jan 2015  Lab test of semen and count  normal results and good motility (14x10^6)  Another troubling fact is that my wife, who received the same Moderna vaccinations, have lost ability to remember any new information sometime in summer of 2021, and after that her brain degeneration was developing exponentially.  Please see report VAERS ID: 2822907, E-Report Number: 1050478 for wife's case.  In addition to this permanent damage to reproductive system, I have also started to notice, since August 2021, heart palpitations. I never had any problems with heart before. I have followed with cardiologist. Ultrasound tests haven't shown any specific issues in the heart. After about two years, palpitations were gone. However, reproductive system was damaged permanently, as confirmed by periodic tests done in 2024 and 2025.    Seeing that two people who received same vaccinations had damaging impacts, one can conclude that either a) it is possible that these specific batches of vaccines are in particular damaging; or b) patient and I were both damaged by vaccine because we came from a very similar ethnic group.   Hope science research on these questions will be launched, helping people in the future.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Father came into pickup line asking clerk about vaccines for him and son. I overheard and thought I heard flu vaccines. I processed and administered. A couple hours later, father came and said wanted COVID vaccine
Age: 64.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: nausea, vomiting, short bouts of dizziness  Symptoms improved within 15 hours. No medication needed.  Could this have just been a stomach virus?  No one else around me has been sick with stomach virus.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Asthenia, Cold sweat, Dizziness, Feeling hot
Clinical narrative: Received TDAP vaccine IM to the left deltoid muscle. Venipuncture for labs was then performed. Lab draw was completed and he complained of feeling hot. His skin then became clammy and he appeared to black out for approx 1 second. He immediately regained consciousness. He was diaphoretic. He was placed in supine position on exam table. He remained alert. Blood pressure was 91/54. BP was 129/90 prior to TDAP dose. He then c/o feeling dizzy, lightheaded, nauseous and reported a stomach ache. He was allowed to rest and provided a gatorade to hydrate himself. After approximately 25 minutes of monitoring he reported feeling better but felt drained with residual nausea. Repeat BP 136/91.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: Received TDAP vaccine IM to the left deltoid muscle. Venipuncture for labs was then performed. Lab draw was completed and he complained of feeling hot. His skin then became clammy and he appeared to black out for approx 1 second. He immediately regained consciousness. He was diaphoretic. He was placed in supine position on exam table. He remained alert. Blood pressure was 91/54. BP was 129/90 prior to TDAP dose. He then c/o feeling dizzy, lightheaded, nauseous and reported a stomach ache. He was allowed to rest and provided a gatorade to hydrate himself. After approximately 25 minutes of monitoring he reported feeling better but felt drained with residual nausea. Repeat BP 136/91.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: Body hives, red splotches on arms, thighs, stomach , shoulders, back
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular symptom, Catheterisation cardiac, Echocardiogram, Magnetic resonance imaging, Myocarditis
Clinical narrative: Myocarditis, typical heart attack symptoms. Hospital 3 days end result us unknow cause of myocarditis
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Myocarditis, typical heart attack symptoms. Hospital 3 days end result us unknow cause of myocarditis
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: I was given Covid19 Vaccine (Pfizer) early Sept 2024. On the night of the day I got the vaccine, I felt pain of blood vessel on the left arm. The patient is like the blood vessel is harshly twisted. I called the clinic that gave the vaccine next day and I was told that it could be due to the formation of blood clot. The pain was gone next day and it has never happened again since then. By Oct 2024, I started to have nose bleeding. It happened once a week in the first few weeks, and by the time of November, it happened 2 to 3 times a week. Since December, nose bleeding has been happening a few times every day. I was given Covid 19 vaccine (Pfizer) three other times in the past couple of years and no side effect was noticed.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Vascular pain
Clinical narrative: I was given Covid19 Vaccine (Pfizer) early Sept 2024. On the night of the day I got the vaccine, I felt pain of blood vessel on the left arm. The patient is like the blood vessel is harshly twisted. I called the clinic that gave the vaccine next day and I was told that it could be due to the formation of blood clot. The pain was gone next day and it has never happened again since then. By Oct 2024, I started to have nose bleeding. It happened once a week in the first few weeks, and by the time of November, it happened 2 to 3 times a week. Since December, nose bleeding has been happening a few times every day. I was given Covid 19 vaccine (Pfizer) three other times in the past couple of years and no side effect was noticed.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Epistaxis, Exposure during pregnancy, Haematuria, Platelet count decreased, Thrombosis with thrombocytopenia syndrome
Clinical narrative: Patient received the Abrysvo RSV vaccine in pregnancy. One week later she developed severe thrombocytopenia (platelet level of zero) that is non-responsive to IVIG. This has required hospitalization, medical intervention, and will complicate her delivery and potential affect her fetus.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Patient received the Abrysvo RSV vaccine in pregnancy. One week later she developed severe thrombocytopenia (platelet level of zero) that is non-responsive to IVIG. This has required hospitalization, medical intervention, and will complicate her delivery and potential affect her fetus.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; 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 PROQUAD was inadvertently administered after suffering from a Te; This spontaneous report has been received from a Nurse referring to a patient of an unknown age and gender.  The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On 11-NOV-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA[recombinant human albumin]) (PROQUAD) injection, 0.5 milliliter, administered as prophylaxis (Lot No. Y013574 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date was not reported but upon internal validation established as 03-FEB-2026) (dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) (product storage error), after a temperature excursion of -11.6 degree Celsius (C) during a time frame of 3 hours, 5 minutes and 0 seconds. Previous temperature excursions could not be confirmed.  No additional adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2501USA007066: US-009507513-2501USA008866: US-009507513-2501USA008885: US-009507513-2501USA009045: US-009507513-2501USA008880: US-009507513-2501USA008935: US-009507513-2501USA008877: US-009507513-2501USA008882: US-009507513-2501USA007047: US-009507513-2501USA007446: US-009507513-2501USA008861:
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site paraesthesia, Injection site reaction
Clinical narrative: PATIENT STATES THAT INJECTION SITE FELT FINE FOR A FEW DAYS AFTER THE VACCINE WAS GIVEN.  AS TIME WENT ON NOTICED TINGLING AT THE INJECTION SITE AND FEELING LIKE MUSCLES WERE MOVING (DESCRIBED LIKE THE MUSCLE WAS A BED OF WORMS).  PATIENT FEELS LIKE THE SENSATION IS GETTING MORE INTENSE AS TIME GOES ON.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chest discomfort, Chills, Cough
Clinical narrative: Approximately 12 hours after administration, pt reported rigors, chills, GI discomfort. Progressed to myalgias, arthralgias, chest discomfort, cough, rash. Fever in office on 1/28/2025 of 103.1 (no fever management prior to visit.)
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Rash
Clinical narrative: Approximately 12 hours after administration, pt reported rigors, chills, GI discomfort. Progressed to myalgias, arthralgias, chest discomfort, cough, rash. Fever in office on 1/28/2025 of 103.1 (no fever management prior to visit.)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial test negative, Breakthrough COVID-19, CSF protein increased, CSF virus no organisms observed, Chills
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient is a 43-year-old male (F->M) with a history of asthma, GAD, mood disorder, PTSD, Htn, anxiety, depression, headache, neck pain diabetes hyperlipidemia who presented with cough, myalgias, and headache. He is a nursing student who has had recent exposure to COVID, flu,and meningitis. He reports double vision that is worse in the left eye. His COVID test came back positive and the patient was admitted on 9/26 for further workup and meningitis rule out. Imaging including CT head, MRI brain were negative for acute process. On 9/27 he underwent a fluoro guided LP by IR to r/o meningitis. His sx were improving at this time. CSF studies showed marginally elevated protein, no other significant findings and biofire resulted as normal for all viral and bacterial pathologies.  Pt experienced fever, myalgia, and chills and also received remdesivir treatment He was cleared for d/c on 9/28. Other Relevant HX: 1. Posttraumatic stress disorder (SNOMED CT 47505003) 2. Intervertebral Disk Displacement * 3. LBP * 4. Hyperkinetic Synd Nos 5. Acne 6. Mastectomy 7. Seizure (SNOMED CT 91175000) 8. Mood Disorder due to a General Medical Condition 9. Asthma (SNOMED CT 195967001) 10. Headache (SNOMED CT 25064002) 11. Neck Pain 12. Hypothyroidism (SNOMED CT 40930008) 13. Hyperlipidemia 14. Cholecystectomy 15. Diarrhea * 16. Vision, Subnormal * 17. Colonoscopy through Stoma 18. Pulp Necrosis 19. Acute apical periodontitis of pulpal origin 20. Seizure (SNOMED CT 91175000)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Cough, Diplopia, Headache, Magnetic resonance imaging head normal
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient is a 43-year-old male (F->M) with a history of asthma, GAD, mood disorder, PTSD, Htn, anxiety, depression, headache, neck pain diabetes hyperlipidemia who presented with cough, myalgias, and headache. He is a nursing student who has had recent exposure to COVID, flu,and meningitis. He reports double vision that is worse in the left eye. His COVID test came back positive and the patient was admitted on 9/26 for further workup and meningitis rule out. Imaging including CT head, MRI brain were negative for acute process. On 9/27 he underwent a fluoro guided LP by IR to r/o meningitis. His sx were improving at this time. CSF studies showed marginally elevated protein, no other significant findings and biofire resulted as normal for all viral and bacterial pathologies.  Pt experienced fever, myalgia, and chills and also received remdesivir treatment He was cleared for d/c on 9/28. Other Relevant HX: 1. Posttraumatic stress disorder (SNOMED CT 47505003) 2. Intervertebral Disk Displacement * 3. LBP * 4. Hyperkinetic Synd Nos 5. Acne 6. Mastectomy 7. Seizure (SNOMED CT 91175000) 8. Mood Disorder due to a General Medical Condition 9. Asthma (SNOMED CT 195967001) 10. Headache (SNOMED CT 25064002) 11. Neck Pain 12. Hypothyroidism (SNOMED CT 40930008) 13. Hyperlipidemia 14. Cholecystectomy 15. Diarrhea * 16. Vision, Subnormal * 17. Colonoscopy through Stoma 18. Pulp Necrosis 19. Acute apical periodontitis of pulpal origin 20. Seizure (SNOMED CT 91175000)
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test positive, X-ray
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient is a 43-year-old male (F->M) with a history of asthma, GAD, mood disorder, PTSD, Htn, anxiety, depression, headache, neck pain diabetes hyperlipidemia who presented with cough, myalgias, and headache. He is a nursing student who has had recent exposure to COVID, flu,and meningitis. He reports double vision that is worse in the left eye. His COVID test came back positive and the patient was admitted on 9/26 for further workup and meningitis rule out. Imaging including CT head, MRI brain were negative for acute process. On 9/27 he underwent a fluoro guided LP by IR to r/o meningitis. His sx were improving at this time. CSF studies showed marginally elevated protein, no other significant findings and biofire resulted as normal for all viral and bacterial pathologies.  Pt experienced fever, myalgia, and chills and also received remdesivir treatment He was cleared for d/c on 9/28. Other Relevant HX: 1. Posttraumatic stress disorder (SNOMED CT 47505003) 2. Intervertebral Disk Displacement * 3. LBP * 4. Hyperkinetic Synd Nos 5. Acne 6. Mastectomy 7. Seizure (SNOMED CT 91175000) 8. Mood Disorder due to a General Medical Condition 9. Asthma (SNOMED CT 195967001) 10. Headache (SNOMED CT 25064002) 11. Neck Pain 12. Hypothyroidism (SNOMED CT 40930008) 13. Hyperlipidemia 14. Cholecystectomy 15. Diarrhea * 16. Vision, Subnormal * 17. Colonoscopy through Stoma 18. Pulp Necrosis 19. Acute apical periodontitis of pulpal origin 20. Seizure (SNOMED CT 91175000)
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anaemia, Asthenia, Breakthrough COVID-19, Chronic obstructive pulmonary disease
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: 77yo male w/ PMh sig for Prostate CA, Barrett's esophagus, h/o esophageal stricture, COPD, and dysarthria admitted to hospital on 09/26 for evaluation/management of Acute hypoxemic respiratory failure thought to be due to an exacerbation of COPD triggered by COVID infection after presenting to hospital w/ 1-2d h/o worsening cough, malaise, weakness, and dyspnea in the setting of COVID19 infection. Patient subsequently noted to have black stools and anemia with concern for UGI bleeding. Pt became medically stable and was discharged on October 3rd, 2024. Other Relevant HX: 1. Asthma (195967001) 2. History of malignant neoplasm of prostate (428262008) 3. Hypertensive heart disease (64715009) 4. Barrett's esophagus (302914006) 5. Abnormal gait (22325002) 6. Chronic low back pain 7. Morbid obesity 8. Osteopenia 9. Primary malignant neoplasm of prostate 10. Arthritis 11. Chronic back pain 12. Degeneration of lumbosacral intervertebral disc 13. Impacted cerumen 14. Arthritis of knee 15. Allergic rhinitis 16. Acute exacerbation of chronic obstructive airways disease 17. Arthropathy of knee joint 18. Chronic obstructive lung disease 19. Nocturia 20. Edema 21. Contact dermatitis 22. At moderate risk of venous thromboembolism 23. Osteoporosis 24. Iron deficiency anemia 25. Gastroesophageal reflux disease 26. Exposure to potentially hazardous substance (133261000119105) Other: Hospitalization
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dyspnoea, Faeces discoloured, Malaise
Clinical narrative: Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: 77yo male w/ PMh sig for Prostate CA, Barrett's esophagus, h/o esophageal stricture, COPD, and dysarthria admitted to hospital on 09/26 for evaluation/management of Acute hypoxemic respiratory failure thought to be due to an exacerbation of COPD triggered by COVID infection after presenting to hospital w/ 1-2d h/o worsening cough, malaise, weakness, and dyspnea in the setting of COVID19 infection. Patient subsequently noted to have black stools and anemia with concern for UGI bleeding. Pt became medically stable and was discharged on October 3rd, 2024. Other Relevant HX: 1. Asthma (195967001) 2. History of malignant neoplasm of prostate (428262008) 3. Hypertensive heart disease (64715009) 4. Barrett's esophagus (302914006) 5. Abnormal gait (22325002) 6. Chronic low back pain 7. Morbid obesity 8. Osteopenia 9. Primary malignant neoplasm of prostate 10. Arthritis 11. Chronic back pain 12. Degeneration of lumbosacral intervertebral disc 13. Impacted cerumen 14. Arthritis of knee 15. Allergic rhinitis 16. Acute exacerbation of chronic obstructive airways disease 17. Arthropathy of knee joint 18. Chronic obstructive lung disease 19. Nocturia 20. Edema 21. Contact dermatitis 22. At moderate risk of venous thromboembolism 23. Osteoporosis 24. Iron deficiency anemia 25. Gastroesophageal reflux disease 26. Exposure to potentially hazardous substance (133261000119105) Other: Hospitalization