chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: describes having developed mild to moderate tinnitus after the first dose; This is a literature report for the following literature source(s).  A 42-year-old nulliparous White female with no past medical history of illness or disease presented to the clinic six months after receiving her two doses of Pfizer COVID-19 vaccine. The patient denies having had COVID-19 previously and describes having developed mild to moderate tinnitus after the first dose. Although she felt it somewhat improving, she was still expected to receive the second shot or compromise her diplomatic status abroad despite her voiced concerns. Discussion: As people continue to ensure appropriate access to COVID-19 mRNA vaccinations, it is as important to know which groups or individuals may not be such candidates. Neurological issues from vaccination may be the direct toxic effect of S-spike proteins as it damages the blood-brain barrier and can lead to immune dysregulation processes. The authors also know tinnitus is not an exclusively auditory problem but may result from neurological changes within the auditory system and has been known to have neurological etiology from peripheral and central cytokine-mediated responses. Tinnitus is not new in the literature after COVID-19 and mRNA vaccines. In fact, recently, a case series of three patients reported tinnitus following Pfizer mRNA vaccination where two of the three people were also younger reaffirming this as a concerning risk factor. The case represents a unique scenario since the patient developed tinnitus after the first shot yet became more pronounced and persistent after the second. According to the literature search, this implies causation with a dose-dependent impact not seen before. Since S-spike protein has already been identified as causing blood-brain barrier permeability as well as promoting intestinal permeability, this may explain such an inflammatory phenomenon.; Sender's Comments: The event of tinnitus is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.,Linked Report(s) : US-PFIZER INC-202500113629 same patient/product/events, different dose;US-PFIZER INC-PV202500066251 Same article/drug; different patient/event;
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: she feels like she have an internal heat of 140F/had been experiencing the internal heat for 4 and a half years; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 79-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset 2021, outcome "not recovered", described as "she feels like she have an internal heat of 140F/had been experiencing the internal heat for 4 and a half years". The events "she feels like she have an internal heat of 140f/had been experiencing the internal heat for 4 and a half years" required physician office visit. Therapeutic measures were taken as a result of feeling hot. Additional information: The reporter is a patient, stated that for the last 4 and a half/5 years, she feels like she have an internal heat of 140F since her Pfizer Covid-19 vaccine shots. She's asking more information if anyone has complained or happened about it as she also has autoimmune disease and "bolus". All COVID-19 vaccines were from Pfizer. When asked if she already went to see her HCP, she stated already went to a clinic and that there was nothing that they could do about it.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: aggressive cancer; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019505 (BioNTech).  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: NEOPLASM MALIGNANT (death), outcome "fatal", described as "aggressive cancer". The patient date of death was unknown. Reported cause of death: "aggressive cancer". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.  COMIRNATY is under agreement with BIONTECH SE.; Reported Cause(s) of Death: aggressive cancer
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: have a mark where injection was given and it was very painful; have a mark where injection was given and it was very painful; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Every booster pfizer (Primary Immunization series complete; Dose number unknown), for Covid-19 immunisation. The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "have a mark where injection was given and it was very painful".  Additional information: The patient just got a covid Comirnaty vaccine. Her last one was 04Sep2024. The patient would like to know why the needle was so big this time. Usually she barely feel the injection. She had had every booster pfizer has put out. This time she had a mark where injection was given and it was very painful. She watched the person gave on to her husband and the needle was so long she was shocked. The patient loved the small ones. She just got a Dtap and it was small and hardly felt it."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Prostate cancer stage IV, Suicidal ideation
Clinical narrative: planning to commit assisted suicide this summer; late stage prostate cancer; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019505 (BioNTech).  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: SUICIDAL IDEATION (medically significant), outcome "unknown", described as "planning to commit assisted suicide this summer"; PROSTATE CANCER STAGE IV (medically significant), outcome "unknown", described as "late stage prostate cancer". The reporter stated that the consequences of Covid and the vaccines used for it were piling up at an increased rate. The patient had late-stage prostate cancer and blamed the vaccines for it. He was planning to commit assisted suicide this summer.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.  COMIRNATY is under agreement with BIONTECH SE.
Vaccine: COVID19, FLUX
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: affects the heart; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "affects the heart".  Additional information: the patient stated that it had a variety of side effects for the COVID vaccine one of which affects the heart.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 83.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired product with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 83 years old male patient who received an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-May-2025, the patient received an expired, 0.5ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Strength Standard, (Once) Suspension for injection, (Unknown strength) lot U7183AA and expiry date 23-Sep-2024 via intramuscular route in the right deltoid for immunization with no reported adverse event (expired product administered) (Latency Same day).  Action taken was not applicable.  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: M
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked to US-SA-2025SA155611.  This case involves an unknown age male patient who was administered with diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] to 0.5 ml that had been exposed to minus 0.8 degree celsius for less than 10 minutes 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 in 2024, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult that has been exposed to minus 0.8 degree celsius for less than 10 minutes with no reported adverse event (poor quality product administered) (product storage error) (Latency: same day) (route, lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA155611:Patient 2
Sex: F
Vaccine: TD
Symptoms: Product storage error
Clinical narrative: was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was administered with Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult [Tenivac] to 0.5 ml that had been exposed to minus 0.8 degree celsius for less than 10 minutes 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 in 2024, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult suspension for injection that had been exposed to minus 0.8 degree celsius for less than 10 minutes (poor quality product administered) (product storage error) (latency: same day) (strength, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. No adverse event was reported. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  Action taken: not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  2025SA155495:
Age: 1.25
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient has already received three doses of IPOL prior, and a fourth dose was administered today, which was too soon, with no reported adverse event; Initial information received on 30-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old male patient who was administered with fourth dose of IPV (VERO) [IPOL] today which was too soon, patient has already received three doses prior 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 an unknown dose 4 of suspect IPV (VERO) Suspension for injection (lot Y1A201M and expiry date- 31-Jan-2027) (strength-unknown) via unknown route in unknown administration site for Immunization today which was too soon, patient has already received three doses prior with no reported adverse event (inappropriate schedule of product administration) (latency-same day).  Action taken was not applicable.   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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Muscle spasms, Tinnitus
Clinical narrative: Tinnitus, cramps, bloating, stomach pain, diarrhea.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Lip swelling, Pruritus, Swelling
Clinical narrative: Patient came into the pharmacy on 6/3/25 and said about 5-6 days after receiving Shingrix he had a swollen neck, headache, itchy palms, and swollen lips. He said the symptoms were resolved by 6/3 except for mild itchiness on his palms.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Lip swelling, Oropharyngeal pain, Pharyngeal swelling, Pruritus
Clinical narrative: Patient came into the pharmacy on 6/3/25 and said about 5-6 days after receiving Shingrix he had a swollen neck, headache, itchy palms, and swollen lips. He said the symptoms were resolved by 6/3 except for mild itchiness on his palms.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Patient came into the pharmacy on 6/3/25 and said about 5-6 days after receiving Shingrix he had a swollen neck, headache, itchy palms, and swollen lips. He said the symptoms were resolved by 6/3 except for mild itchiness on his palms.
Age: 1.58
Sex: M
Vaccine: PNC20
Symptoms: Febrile convulsion
Clinical narrative: Simple febrile seizure the evening after the vaccination was given.  Temp was 103 at that time.  Lasted 5 minutes.
Age: 1.33
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Mass
Clinical narrative: With report of facial bumps on RIGHT cheek - occurred 2 weeks after getting vaccines. Parent concerned due to pfizer vaccine as a vaccine error occurred and patient was given a higher dose of pfizer.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: red spot noted at sight in am 6/4 by afternoon approx 24 hours after site had grown to about 2-3 inches and was red and warm to touch.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Mobility decreased, Myalgia
Clinical narrative: Patient describes onset of headache about 30 minutes after injection. During the night she developed muscle pains. By the next morning (5/28/25) she couldn't move her neck. By 5/29/25 she had difficulty swallowing. After a doctor visit, she was prescribed Tizanidine and Tylenol on 5/30/25, which was filled at a different pharmacy. Patient came in on 6/4/25 to the pharmacy to report - still has residual headaches.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Hypertension
Clinical narrative: 36 hours after receiving the vaccine pt said she was having a fast heart rate and high blood pressure...was checked out by paramedics and HR was 120, BP was 190/120... refused to go to ER and spoke to her PCP... pt was on a beta blocker and was told to take a double dose.  That worked to control her blood pressure back to normal and hasn't had any other symptoms since.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Feeling abnormal, Hyperhidrosis, Malaise, Muscle contractions involuntary
Clinical narrative: 0955 Heplisav B #4 given Left Deltoid 1000 Conversing with candidate to schedule Hep titer and putting in her phone 1005 Candidate states "she doesn't feel good" becomes pale & sweating, water offered & cold rag to face. No breathing issues. 1010 Candidates mother called to pick up candidate. Still feeling weird.  1015 Candidate unresponsive for 1 minute opens eyes suddenly with eyes dilated (pupils) fists to chest shaking states she was dreaming 1020 juice given 83P 80/52 BP O2 sats Room Air 98% 1025 Candidate stated she was cramping & needed to have BM, walked with RN to bathroom. Had BM then sweating profusely. Candidate immediately after layed on floor with feet up on comode stating she was cramping and felt terrible.  1030 Candidate helped to recliner layed back, fanning patient. V/S 59P 99% on RA, 90/60 B/P parents to be seen by medical provider. 1040 Candidate wheelchaired to front entrance with parents. Candidate going to see PCP.  1400 Candidate called to state she saw her PCP / Nurse Practioner with no further issues.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Mydriasis, Pallor, Tremor, Unresponsive to stimuli
Clinical narrative: 0955 Heplisav B #4 given Left Deltoid 1000 Conversing with candidate to schedule Hep titer and putting in her phone 1005 Candidate states "she doesn't feel good" becomes pale & sweating, water offered & cold rag to face. No breathing issues. 1010 Candidates mother called to pick up candidate. Still feeling weird.  1015 Candidate unresponsive for 1 minute opens eyes suddenly with eyes dilated (pupils) fists to chest shaking states she was dreaming 1020 juice given 83P 80/52 BP O2 sats Room Air 98% 1025 Candidate stated she was cramping & needed to have BM, walked with RN to bathroom. Had BM then sweating profusely. Candidate immediately after layed on floor with feet up on comode stating she was cramping and felt terrible.  1030 Candidate helped to recliner layed back, fanning patient. V/S 59P 99% on RA, 90/60 B/P parents to be seen by medical provider. 1040 Candidate wheelchaired to front entrance with parents. Candidate going to see PCP.  1400 Candidate called to state she saw her PCP / Nurse Practioner with no further issues.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Crying, Diarrhoea, Discomfort, Pyrexia, Rash
Clinical narrative: ? Persistent, inconsolable crying for 3?4 days ? Low-grade fever 3-4 days ? Mild full-body rash 3-4 days ? Diarrhea 3-4 days ? Discomfort when laid flat or touched 3-4 days
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea/vomiting within 2 hours of administration of meningococcal serogroup B vaccination
Age: 16.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 78.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: R & L Shoulder were both sore after injections. R side got better but L did not. Arm was sore and could not lift arm up all the way without pain. No redness, swelling or warmth. Shoulder is sore and has pain even with slight internal rotation. Dx with SIRVA. Referred pt to Physical Therapy
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Alpha tumour necrosis factor, Amnesia, Angle closure glaucoma, Antigliadin antibody
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Binocular eye movement disorder, Blood copper normal, Blood glucose normal
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood zinc normal, Borrelia test, C-reactive protein normal, Chemokine test, Chills
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Contusion, Cytokine increased, Diarrhoea, Dizziness
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Granulocyte-colony stimulating factor test, Haematuria, Headache, Herpes simplex test positive
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heterophoria, Hyperacusis, Hypertension, Hypertensive crisis, Impaired work ability
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interferon gamma release assay, Interleukin level, Irritable bowel syndrome, Laboratory test normal, Macrophage inflammatory protein-1 alpha
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Memory impairment, Metabolic function test normal, Nausea, Pain
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Red blood cells urine positive, SARS-CoV-2 antibody test positive, Serum ferritin normal, Somnolence
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Tinnitus, Vascular endothelial growth factor assay, Vertigo, Vestibular migraine
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Weight decreased
Clinical narrative: 12/19/2020 Pfizer covid-19 vaccine #1 1/6/2021: c/o "worse headache in life" fever, chills, pain everywhere as if beaten with a hammer.  Slept all day and for next several days until 1/12/2021.  Taking Theraflu daily. Was able to telework.   1/13/2021 Pfizer covid-19 vaccine #2 - States was covered in bruises and lost 40 lbs.  Went to ER April 2021 at kids request where diagnosed with IBS.  "I'm a shell of the person I was".   Assigned case:  current complaints attributed to receipt of Pfizer covid vaccine include:  pulsatile tinnitus, intermittent vertigo, vestibular migraines, hyperacusis, memory loss (improved), convergence disorder, visual memory errors, vertical heterophoria, acute glaucoma, speech difficulties (gibberish), and blurry vision (bilateral). Additional systemic symptoms include uncontrollable hypertension, hypertensive crises, irritable bowel syndrome (IBS) with resolved diarrhea, abdominal pain, diarrhea, dizziness, nausea, hematuria, and limited work ability, leading to permanent disability as documented in her VAERS report.
Sex: F
Vaccine: MMR, MMR
Symptoms: Cyanosis, Erythema, Livedo reticularis, Pyrexia
Clinical narrative: marbled bluish red skin condition - diagnosed with Cutis Marmorata; consistent fever of 102 at night; This spontaneous report was received from a Nurse via company representative on 30-May-2025 concerning to her daughter a 1-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 23-May-2025,reported as a week ago,  the patient was vaccinated with a first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)(lot # ,expiration date, dose, and route were not reported) and with sterile diluent (MERCK STERILE DILUENT)(lot # , expiration date, dose, and route of administration were not reported) for prophylaxis.  On 24-May-2025, the patient experienced consistent fever of 102 at night despite Motrin and marbled bluish red skin condition. The Child was seen in the emergency department last night, on 29-MAY-2025 and was diagnosed with Cutis Marmorata.   At the reporting time, the outcome of marbled bluish red skin condition/diagnosed with Cutis Marmorata and consistent fever of 102 at night was unknown.  The causality between the event events, Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II and with sterile diluent (MERCK STERILE DILUENT) was unspecified.
Vaccine: MMR, MMR, MMR
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No symptoms reported.; a patient who was inadvertently administered MMR-II instead of hepatitis B vaccine (manufacturer unspecified) on 05/28/2025.; this was the patient's third dose of MMR-II (first dose was administered on 06/2023 and second dose was administered on 07/2023; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in June 2023 and July 2023, the patient was vaccinated with the first and second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, strength, route of administration, lot#, and expiration date were not reported) for prophylaxis. On 28-MAY-2025, the patient was inadvertently administered Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (0.5 ml/ dose, lot#: Z002520, expiration date: 07-JAN-2027; route of administration was not reported) instead of hepatitis B vaccine (manufacturer unspecified) for prophylaxis (wrong product administered and extra dose administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, strength, route of administration, lot#, and expiration date were not reported). No additional adverse events (AE) details were reported (no adverse event).
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a men b immunization was charted in the hcp's system, but the patient should not have had men b at their particular age with no reported adverse event; Initial information received on 27-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves child of unknown age and is reported meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] immunization was charted in the hcp's (healthcare progessional) system, but the patient should not have had men b at their particular age 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, suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine Solution for injection of lot U6455CA and expiry date: 15-Nov-2020 (strength, dose: not reported) via unknown route in unknown administration site for immunization was charted in the hcp's system, but the patient should not have had men b at their particular age with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day).  Action taken was not applicable.  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: 57.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: YF-VAX was given to a patient and the diluent used was sterile water with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from  a physician.  This case involves 57 years old female patient to whom yellow fever vaccine -[YF-VAX] was given and the diluent used was sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-May-2025, the patient received a dose of 0.5 ml of suspect yellow fever vaccine, Solution for injection (lot UK118AA, expiry date 30-Sep-2025, strength: standard, frequency: once) via subcutaneous route in unknown administration site for immunisation and the diluent used was sterile water with no reported adverse event (product preparation error) (Latency: same day).  Reportedly, an inappropriate use due to the use of an alternate diluent and not using the one supplied with the product.  Action taken was not applicable.   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: 10.0
Sex: F
Vaccine: YF
Symptoms: Extra dose administered
Clinical narrative: inadvertently giving an extra dose of YF-VAX to a patient with no reported adverse event; YF-VAX given as IM to a patient  with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 10 years old female patient who inadvertently administered an extra dose  yellow fever vaccine - [YF-VAX] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications Included Typhoid Vaccine Polysacch VI (TYPHIM VI) for Immunisation.  On 31-May-2025, the patient inadvertently received 2 doses of (0.5 ml dose) of suspect yellow fever vaccine, lot UK137AA, via subcutaneous route,UK137AA via intramuscular route both with (formulation :Solution for injection, expiry date:31-Jan-2026,strength :standard, frequency: once) in unknown administration site for Immunization with no reported adverse event (extra dose administered) (incorrect route of product administration) (latency: same day).  Reportedly, She said that she had multiple patients that were going to another country; they needed a vaccination of YF-VAX and TYPHIM VI.   Action taken was not applicable.  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: 1.08
Sex: F
Vaccine: DTAPIPVHIB, DTP
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: inappropriate use due to administration of the wrong vaccine with no reported adverse event; giving the next dose of Hib too early with no reported adverse event; an extra dose of IPV was given with no reported adverse event; Initial information received on 02-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old female patient who was inappropriately administered with wrong vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] instead of Diphtheria, Tetanus And Nos Pertussis Vaccine with no reported adverse event and   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Polio Vaccine Inact 3v (Vero) (Ipol Polio Vaccine) for Immunisation.  On 02-Jun-2025, the patient was inappropriate administered with wrong vaccine of 0.5mL Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK017AA, expiry date 30-Jun-2025; strength standard and frequency once) via intramuscular route in the left thigh for Immunization (wrong product administered) instead of Diphtheria, Tetanus And Nos Pertussis Vaccine and the Hib vaccine was given earlier than scheduled with (inappropriate schedule of product administration) (latency same day) and (extra dose administered).  Reportedly, the reporter called to report that Pentacel and Ipol were incorrectly administered to a patient. She explained that the vaccines to be given was suppose to be a Dtap and Polio. She also asked for any information or guidance in this event that an extra dose of IPV was given and that the Hib vaccine was given earlier than scheduled. She added that the patient's Hib vaccine was scheduled in October 2025 since it was given last April 2025.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA158247: