chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebellar stroke, Diplopia, Dizziness, Echocardiogram, Magnetic resonance imaging head abnormal
Clinical narrative: I am an active 65 year old man.  I bike 300 miles per month.  On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo.  I felt sick to my stomach.  The room was spinning.  I was nauseous.  I was at a restaurant with my wife at the time.  After about 15 minutes, it dissipated.  I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening.  2 days later on Sunday morning, February 3, I went for my bike ride.  After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me.  Once again, they dissipated about 15 minutes later.  My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out.  We discussed possible treatment for vertigo.  But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5.  The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER.  In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound.  Those tests both were negative.  My arteries in my neck and the back of my head were also checked through an ultrasound with dye.  Those tests showed my arteries were clear.  I was released from the hospital about 48 hours after admittance.  I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision.  The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB.  I visited my opthamologist re the double vision.  She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed.  She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes.  She thought over time the double vision would disappear.  As of today I still have permanent double vision.  I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily).  I am also required to take aspirin every day (81 mg).  And, I worry about a possible future stroke and so does my wife of 45 years.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Scan with contrast normal, Ultrasound Doppler, Ultrasound head, Ultrasound scan normal
Clinical narrative: I am an active 65 year old man.  I bike 300 miles per month.  On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo.  I felt sick to my stomach.  The room was spinning.  I was nauseous.  I was at a restaurant with my wife at the time.  After about 15 minutes, it dissipated.  I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening.  2 days later on Sunday morning, February 3, I went for my bike ride.  After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me.  Once again, they dissipated about 15 minutes later.  My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out.  We discussed possible treatment for vertigo.  But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5.  The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER.  In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound.  Those tests both were negative.  My arteries in my neck and the back of my head were also checked through an ultrasound with dye.  Those tests showed my arteries were clear.  I was released from the hospital about 48 hours after admittance.  I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision.  The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB.  I visited my opthamologist re the double vision.  She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed.  She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes.  She thought over time the double vision would disappear.  As of today I still have permanent double vision.  I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily).  I am also required to take aspirin every day (81 mg).  And, I worry about a possible future stroke and so does my wife of 45 years.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: I am an active 65 year old man.  I bike 300 miles per month.  On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo.  I felt sick to my stomach.  The room was spinning.  I was nauseous.  I was at a restaurant with my wife at the time.  After about 15 minutes, it dissipated.  I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening.  2 days later on Sunday morning, February 3, I went for my bike ride.  After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me.  Once again, they dissipated about 15 minutes later.  My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out.  We discussed possible treatment for vertigo.  But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5.  The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER.  In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound.  Those tests both were negative.  My arteries in my neck and the back of my head were also checked through an ultrasound with dye.  Those tests showed my arteries were clear.  I was released from the hospital about 48 hours after admittance.  I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision.  The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB.  I visited my opthamologist re the double vision.  She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed.  She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes.  She thought over time the double vision would disappear.  As of today I still have permanent double vision.  I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily).  I am also required to take aspirin every day (81 mg).  And, I worry about a possible future stroke and so does my wife of 45 years.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blindness, Headache, Herpes zoster, Neuralgia
Clinical narrative: shingles including loss of eye sight, intense headache , weight loss, rash, scarring, bedridden for 4 months-2 months in the dark, headaches and nerve  pain still ongoing today.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Scar, Weight decreased
Clinical narrative: shingles including loss of eye sight, intense headache , weight loss, rash, scarring, bedridden for 4 months-2 months in the dark, headaches and nerve  pain still ongoing today.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Furuncle, Impaired work ability, Localised infection, Pain, Wound
Clinical narrative: My arm swelled up like a boil and a week and a half later white spots showed up a day later the boil burst i went to the emergency room 08/08/2025 theybsaid was infected gave mw anitibiotics i called off work 08/09/2025 due to pain and pus, now i have two holes in my shot, no one cleaned tge infection or packed at facility. Im still in pain and going back today 08/11/2025
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Hallucination, auditory, Mobility decreased, Palpitations
Clinical narrative: Client states he began to react within 30 minutes of administration. Heart started racing, SOB. Went to Hospital 2-3 times. States he spent weeks on the couch unable to get up off of it due to weakness and heart palpations. He also experienced psychosis/mental illness episodes of hearing voices. Client is now able to work and states he is pretty much back to normal.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: Client states he began to react within 30 minutes of administration. Heart started racing, SOB. Went to Hospital 2-3 times. States he spent weeks on the couch unable to get up off of it due to weakness and heart palpations. He also experienced psychosis/mental illness episodes of hearing voices. Client is now able to work and states he is pretty much back to normal.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site indentation, Vaccination failure
Clinical narrative: created an indent on the injection site; Patient is claiming that the vaccine was given sub-Q rather than intramuscularly; Patient believes that the vaccine was ineffective; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Subcutaneous use) .5 milliliter. On an unknown date, the patient experienced INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective). At the time of the report, INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Subcutaneous use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had no medical history, concomitant disease or risk factor.  No other vaccines within the past 4 weeks and no relevant medical history were reported as per HCP.  According to the HCP, after the vaccination, the patient reported that the vaccine was given subcutaneously instead of intramuscularly and noted an indent at the injection site. The patient believed that the vaccine was ineffective and subsequently requested a second dose of Spikevax. HCP inquired whether administering another dose would be appropriate.  It was unknown if the patient experienced any additional symptoms or events.  There were no lab data or results available.  No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jul2025 as dose 1, single (Lot number: LN4930), in arm (deltoid) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset Jul2025, outcome "recovered" (Jul2025); SWELLING (non-serious) with onset Jul2025, outcome "recovered" (Jul2025), described as "large swelling"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset Jul2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow". The event "cellulitis" required emergency room visit. Therapeutic measures taken as a result of cellulitis included antibiotics.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available.  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-202500159684 same drug/events, different patient;
Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose 1, single (Lot number: LN4930), in arm (deltoid) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset 30Jun2025, outcome "recovered" (Jul2025); SWELLING (non-serious) with onset 30Jun2025, outcome "recovered" (Jul2025), described as "large swelling"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset 30Jun2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow". The event "cellulitis" required emergency room visit. Therapeutic measures taken as a result of cellulitis included antibiotics.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available.  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-202500159636 same drug/event, different patient;
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Their Covid vaccine gave me a rash; 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Their Covid vaccine gave me a rash". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: TDAP
Symptoms: Coeliac disease, Rash
Clinical narrative: in the 13 years she received Sanofi's Tdap vaccine, she has developed celiac disease; develop a rash; Initial information received on 04-Aug-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp 9healthcare professional).  This case involves an unknown age female patient who had celiac disease and rash after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  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 suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for Immunization.  Information regarding batch number corresponding to the one at time of event occurrence is requested.  On an unknown date the patient developed celiac disease (coeliac disease) and develop a rash (rash) (unknown latency).  Reportedly, A female patient reported a 13-year rash from Sanofi's Tdap vaccine, which she reported as an adverse event. Now, her doctor is considering another Tdap vaccine, but she is concerned about the vaccine's gluten content, as she has developed celiac disease.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.  Seriousness Criteria: This event was assessed as medically significant (coeliac disease).; Sender's Comments: Sanofi Company Comment dated 06-Aug-2025,This case involves an unknown age female patient who had celiac disease and rash after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. Further information regarding tolerance, allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the  suspect vaccine cannot be assessed.
Vaccine: MEN
Symptoms: Malaise
Clinical narrative: I almost died  from the Meningitis jab; This serious case was reported by a consumer and described the occurrence of near death experience in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced near death experience (Verbatim: I almost died  from the Meningitis jab) (serious criteria GSK medically significant). The outcome of the near death experience was not reported.   The reporter considered the near death experience to be related to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device.     The company considered the near death experience to be unrelated to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Additional Information: GSK Receipt Date: 04-AUG-2025 Consumer reported that almost died from the Meningitis jab as a teenager, but we did not know it at the time. This case has been linked with the caseUS2025AMR103054 and US2025AMR101206, reported by same reporter.; Sender's Comments: A case of Near death experience, on an unknown time after receiving Meningococcal B vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK Meningococcal B vaccine and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE cannot be ascertained. Consent for further follow up has not been received US-GSK-US2025AMR101206:Case created for kids US-GSK-US2025AMR103054:Same reporter/kids
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Muscle swelling, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Arm pain, swollen deltoid, bruising and tenderness, tingling down the arm
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Rash papular
Clinical narrative: SMALL RED RAISED DOTS APPEARED ON THE TOP OF BOTH THIGHS THE NEXT DAY - NO ITCHING
Age: 40.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received a double dose of Boostrix. First dose on 2/21/2025 and second dose on 8/5/2025.
Age: 16.0
Sex: F
Vaccine: FLU3, MMR, MNQ
Symptoms: Syncope
Clinical narrative: Patient syncope
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Ophthalmic herpes zoster, Pruritus, Vaccination failure
Clinical narrative: It affected my right eye; singles beginning 9/19/24 on my  forehead on the right side; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 19-SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: singles beginning 9/19/24 on my  forehead on the right side). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: It affected my right eye) (serious criteria GSK medically significant). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 08-AUG-2025 This case was reported by a patient via interactive digital media. Patient had singles beginning 19th September 2024 on his/her forehead on the right side.  It affected his/her right eye.  It was nearly one year and he/she still had a red mark over his/her eyebrow and itching. If patient had not been vaccinated it would have been much worse. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out;  This serious case was reported by a nurse via call center representative and described the occurrence of passed out in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9X7DC, expiry date 31-JAN-2026) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number 5XA2U, expiry date 31-MAY-2028) for prophylaxis.   On 31-JUL-2025, the patient received Menveo and Bexsero. On 31-JUL-2025, less than a day after receiving Menveo and Bexsero, the patient experienced passed out (Verbatim: Patient passed out) (serious criteria GSK medically significant). The outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the passed out to be unrelated to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-JUL-2025 The nurse reported that a patient received Menveo (1-vial) along with Bexsero on the day of reporting and she had a reaction, she passed out.; Sender's Comments: A case of Loss of consciousness, less than a day after receiving Menveo, Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE, in a 17-year-old female patient. Causal relation is indeterminate considering multiple vaccines given concomitantly.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: called moderna every time come down with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (called moderna every time come down with covid) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received tenth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (called moderna every time come down with covid). At the time of the report, COVID-19 (called moderna every time come down with covid) outcome was unknown.      Concomitant medication was not reported.  Patient wanted to know when the newest formulation will be released. Patient had moderna Covid Vaccine 10 times. It was unknown if the patient experienced any additional symptoms/events.  Treatment medication was not reported.   This case was linked to MOD-2022-660956, MOD-2025-782652 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted COVID-19 despite being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19 despite being vaccinated) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Cancer and Immunocompromised.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID-19 despite being vaccinated). At the time of the report, COVID-19 (contracted COVID-19 despite being vaccinated) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported. The patient didn't experienced symptoms following vaccination and mentioned that his immune system was somewhat compromised due to a past cancer diagnosis. Furthermore, he contracted COVID-19 despite being vaccinated but recovered without complications. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
Vaccine: COVID19
Symptoms: Diarrhoea, Neoplasm malignant, Systemic lupus erythematosus
Clinical narrative: lupus; cancer; diarrhea; The initial case was missing the following minimum criteria: Unidentifiable reporter. Upon receipt of follow-up information on (03Feb2025), this case now contains all required information to be considered valid. 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: lose a ton of hair within a few days of getting it; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: ALOPECIA (non-serious), outcome "unknown", described as "lose a ton of hair within a few days of getting it".  Additional information: Chat question Verbatim: If your covid 19 vaccine caused me to lose a ton of hair within a few days of getting it, what disorder do I have and what are the remedies?  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: I am suffering with an auto immune disease after my second covid vaccine, what should I do?; 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "I am suffering with an auto immune disease after my second covid vaccine, what should I do?".  Clinical course: AE description: Unique Identification number: NA, UTC Time stamp: 08Aug2025 7:20:30AM, Chat question Verbatim: I am suffering with an auto immune disease after my second covid vaccine, what should I do?  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myelodysplastic syndrome
Clinical narrative: MDS; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) 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: MYELODYSPLASTIC SYNDROME (disability, medically significant), outcome "not recovered", described as "MDS". It was unknown if therapeutic measures were taken as a result of myelodysplastic syndrome.  Clinical course: Patient self reports that, FMD that she has MDS as a result of the Covid vaccination. It was unknown that other vaccine was received on same date,  other vaccine in four weeks and other medications in two weeks.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 3 weeks later got covid really bad; 3 weeks later got covid really bad; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 1, single (Lot number: FC3180), in arm and on 10Sep2021 as dose 2, single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "3 weeks later got covid really bad".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500160813 same patient, different dose/events;
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Dyspnoea, Echocardiogram, Malaise, Muscle atrophy
Clinical narrative: 3 weeks later got covid really bad; 3 weeks later got covid really bad; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 1, single (Lot number: FC3180), in arm and on 10Sep2021 as dose 2, single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "3 weeks later got covid really bad".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500160813 same patient, different dose/events;
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary arterial hypertension
Clinical narrative: 3 weeks later got covid really bad; 3 weeks later got covid really bad; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 as dose 1, single (Lot number: FC3180), in arm and on 10Sep2021 as dose 2, single (Lot number: FF2587), in arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "3 weeks later got covid really bad".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500160813 same patient, different dose/events;
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Pulmonary Arterial Hypertension in the right chamber of my hear; I am only 41 and my body feels like it is shutting down most days; I continued to have problems with my breathing; I now use a walker since my muscles are also starting to shutdown; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 2, single (Lot number: FF2587) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: FC3180, in arm at Pharmacy or Drug Store), administration date: 20Aug2021, when the patient was 37-year-old, for Covid-19 Immunization. The following information was reported: MALAISE (disability) with onset 06Mar2023, outcome "not recovered", described as "I am only 41 and my body feels like it is shutting down most days"; DYSPNOEA (disability) with onset 06Mar2023, outcome "not recovered", described as "I continued to have problems with my breathing"; MUSCLE ATROPHY (disability) with onset 06Mar2023, outcome "not recovered", described as "I now use a walker since my muscles are also starting to shutdown"; PULMONARY ARTERIAL HYPERTENSION (disability, medically significant) with onset 06Mar2023, outcome "not recovered", described as "Pulmonary Arterial Hypertension in the right chamber of my hear". The event "pulmonary arterial hypertension in the right chamber of my hear" required physician office visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Pulmonary Arterial Hypertension; Echocardiogram: Pulmonary Arterial Hypertension. Therapeutic measures were taken as a result of pulmonary arterial hypertension, malaise, dyspnoea, muscle atrophy.  Clinical course: Patient reported that her body feels like it is shutting down most days. Had 1st and 2nd dose of the Pfizer vaccines in Aug2021 and Sep2021. 3 weeks later, she got covid really bad. She continued to have problems with breathing, so in Feb2023, she saw her doctor and they referred her to a cardiologist that did the right catheterization in neck and TEE test and diagnosed with Pulmonary Arterial Hypertension in the right chamber of heart. Patient is taking 4 medications that she will now be on the rest of her life. Patient now use a walker since her muscles are also starting to shut down. Worst decision ever getting the vaccine. Patient had no issues prior to the Pfizer vaccines.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Dyspnoea, Echocardiogram, Malaise, Muscle atrophy
Clinical narrative: Pulmonary Arterial Hypertension in the right chamber of my hear; I am only 41 and my body feels like it is shutting down most days; I continued to have problems with my breathing; I now use a walker since my muscles are also starting to shutdown; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 2, single (Lot number: FF2587) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: FC3180, in arm at Pharmacy or Drug Store), administration date: 20Aug2021, when the patient was 37-year-old, for Covid-19 Immunization. The following information was reported: MALAISE (disability) with onset 06Mar2023, outcome "not recovered", described as "I am only 41 and my body feels like it is shutting down most days"; DYSPNOEA (disability) with onset 06Mar2023, outcome "not recovered", described as "I continued to have problems with my breathing"; MUSCLE ATROPHY (disability) with onset 06Mar2023, outcome "not recovered", described as "I now use a walker since my muscles are also starting to shutdown"; PULMONARY ARTERIAL HYPERTENSION (disability, medically significant) with onset 06Mar2023, outcome "not recovered", described as "Pulmonary Arterial Hypertension in the right chamber of my hear". The event "pulmonary arterial hypertension in the right chamber of my hear" required physician office visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Pulmonary Arterial Hypertension; Echocardiogram: Pulmonary Arterial Hypertension. Therapeutic measures were taken as a result of pulmonary arterial hypertension, malaise, dyspnoea, muscle atrophy.  Clinical course: Patient reported that her body feels like it is shutting down most days. Had 1st and 2nd dose of the Pfizer vaccines in Aug2021 and Sep2021. 3 weeks later, she got covid really bad. She continued to have problems with breathing, so in Feb2023, she saw her doctor and they referred her to a cardiologist that did the right catheterization in neck and TEE test and diagnosed with Pulmonary Arterial Hypertension in the right chamber of heart. Patient is taking 4 medications that she will now be on the rest of her life. Patient now use a walker since her muscles are also starting to shut down. Worst decision ever getting the vaccine. Patient had no issues prior to the Pfizer vaccines.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary arterial hypertension
Clinical narrative: Pulmonary Arterial Hypertension in the right chamber of my hear; I am only 41 and my body feels like it is shutting down most days; I continued to have problems with my breathing; I now use a walker since my muscles are also starting to shutdown; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 2, single (Lot number: FF2587) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Slight adhesive allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; lot number: FC3180, in arm at Pharmacy or Drug Store), administration date: 20Aug2021, when the patient was 37-year-old, for Covid-19 Immunization. The following information was reported: MALAISE (disability) with onset 06Mar2023, outcome "not recovered", described as "I am only 41 and my body feels like it is shutting down most days"; DYSPNOEA (disability) with onset 06Mar2023, outcome "not recovered", described as "I continued to have problems with my breathing"; MUSCLE ATROPHY (disability) with onset 06Mar2023, outcome "not recovered", described as "I now use a walker since my muscles are also starting to shutdown"; PULMONARY ARTERIAL HYPERTENSION (disability, medically significant) with onset 06Mar2023, outcome "not recovered", described as "Pulmonary Arterial Hypertension in the right chamber of my hear". The event "pulmonary arterial hypertension in the right chamber of my hear" required physician office visit. The patient underwent the following laboratory tests and procedures: Catheterisation cardiac: Pulmonary Arterial Hypertension; Echocardiogram: Pulmonary Arterial Hypertension. Therapeutic measures were taken as a result of pulmonary arterial hypertension, malaise, dyspnoea, muscle atrophy.  Clinical course: Patient reported that her body feels like it is shutting down most days. Had 1st and 2nd dose of the Pfizer vaccines in Aug2021 and Sep2021. 3 weeks later, she got covid really bad. She continued to have problems with breathing, so in Feb2023, she saw her doctor and they referred her to a cardiologist that did the right catheterization in neck and TEE test and diagnosed with Pulmonary Arterial Hypertension in the right chamber of heart. Patient is taking 4 medications that she will now be on the rest of her life. Patient now use a walker since her muscles are also starting to shut down. Worst decision ever getting the vaccine. Patient had no issues prior to the Pfizer vaccines.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old female 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. Patient have been taking the Pfizer vaccine for COVID every six months and today it was reported that patient was still diagnosed with COVID-19 on an unspecified date. She was prescribed with unspecified medication and was very expensive. Outcome of the events was unknown.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid vaccine from Pfizer but still ended up with covid; got covid vaccine from Pfizer but still ended up with covid; 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid vaccine from Pfizer but still ended up with covid".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: it didn't work for her because she got covid now; it didn't work for her because she got covid now; This is a spontaneous report received from a Consumer or other non HCP.  A female 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "it didn't work for her because she got covid now". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: after getting 3 shots with booster my eyes started to get blurry; 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "after getting 3 shots with booster my eyes started to get blurry". Additional information: Patient read in the news that Pfizer covid vaccine causes eye damages and reported "after getting 3 shots with booster my eyes started to get blurry".
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Alopecia, Anxiety, Blood test, Brain fog
Clinical narrative: Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chills, Cholecystectomy, Colonoscopy, Computerised tomogram abdomen
Clinical narrative: Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Decreased appetite, Depression, Electrocardiogram, Endoscopy upper gastrointestinal tract
Clinical narrative: Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Hepatobiliary scan, Hyperacusis, Inflammation
Clinical narrative: Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Laboratory test, Nausea, Palpitations, Parosmia
Clinical narrative: Severe nausea, headaches, chills, fever, sounds and smells were intolerable and a rash. Nausea, insomnia, anxiety, depression, fatigue, hair loss, brain fog, no appetite,inflammation palpatations, rash, no activity and headaches still active after 5 years of seeing several Emergency room visits,Gastrointerologist, Neurologist, ENT, Obgyn, Endo, Ent &Aprn Treated with Zofran, Meclizine,bactrim,buspar,famodine