chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: RVX, RVX
Symptoms: Quadriplegia
Clinical narrative: Guillain-Barre syndrome; total body paralysis from feet to eyes/ could not move or swallow; Severe nerve reaction;  This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant), quadraplegic (Verbatim: total body paralysis from feet to eyes/ could not move or swallow) (serious criteria GSK medically significant) and neurologic reaction (Verbatim: Severe nerve reaction). The outcome of the guillain barre syndrome, quadraplegic and neurologic reaction were not reported.   It was unknown if the reporter considered the guillain barre syndrome, quadraplegic and neurologic reaction to be related to RSV vaccine.     The company considered the guillain barre syndrome, quadraplegic and neurologic reaction to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and had a severe nerve reaction. By the end of the week the patient was in the emergency room with Guillain-Barre syndrome. One of the first questions that was asked was if patient had gotten the RSV vaccine. The patient eventually had total body paralysis from his/her feet to his/her eyes. The patient could not move or swallow. The patient used feeding tube and months in rehab to learn how to walk again. The patient advised to not get this vaccine.; Sender's Comments: A case of Guillain-Barre syndrome and Quadriplegia, on an unknown date after receiving RSV vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Vaccine: RVX, RVX
Symptoms: Gait inability, Gastrointestinal tube insertion, Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain-Barre syndrome; total body paralysis from feet to eyes/ could not move or swallow; Severe nerve reaction;  This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria GSK medically significant), quadraplegic (Verbatim: total body paralysis from feet to eyes/ could not move or swallow) (serious criteria GSK medically significant) and neurologic reaction (Verbatim: Severe nerve reaction). The outcome of the guillain barre syndrome, quadraplegic and neurologic reaction were not reported.   It was unknown if the reporter considered the guillain barre syndrome, quadraplegic and neurologic reaction to be related to RSV vaccine.     The company considered the guillain barre syndrome, quadraplegic and neurologic reaction to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and had a severe nerve reaction. By the end of the week the patient was in the emergency room with Guillain-Barre syndrome. One of the first questions that was asked was if patient had gotten the RSV vaccine. The patient eventually had total body paralysis from his/her feet to his/her eyes. The patient could not move or swallow. The patient used feeding tube and months in rehab to learn how to walk again. The patient advised to not get this vaccine.; Sender's Comments: A case of Guillain-Barre syndrome and Quadriplegia, on an unknown date after receiving RSV vaccine in a patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Vaccine: RVX, RVX
Symptoms: Dysphagia, Gastrointestinal tube insertion, Guillain-Barre syndrome, Movement disorder, Neurological symptom
Clinical narrative: Guillian-Barre Syndrome; paralyzed from my eyes to my feet; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 23-DEC-2024, the patient received RSV vaccine. In DEC-2024, less than 2 weeks after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria GSK medically significant and life threatening) and paralysis (Verbatim: paralyzed from my eyes to my feet) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were not reported.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to RSV vaccine.     The company considered the guillain barre syndrome and paralysis to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 09-AUG-2025  This case was reported by a patient via interactive digital media. The patient stated the Respiratory Syncytial Virus vaccine almost killed her/him. The patient received Respiratory Syncytial Virus vaccine. and on new year's evening he/she was in the emergency room with severe, near fatal case of guillian-barre syndrome, paralyzed from his/her eyes to feet.  The first thing that they asked him/her in the emergency room was if he/she had gotten the Respiratory Syncytial Virus vaccine.  Feeding tube and months of rehabilitation later, to learn how to walk again, luckily, he/she survived.; Sender's Comments: A case of Guillain-Barre syndrome, less than 2 weeks after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Vaccine: RVX, RVX
Symptoms: Quadriplegia
Clinical narrative: Guillian-Barre Syndrome; paralyzed from my eyes to my feet; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 23-DEC-2024, the patient received RSV vaccine. In DEC-2024, less than 2 weeks after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria GSK medically significant and life threatening) and paralysis (Verbatim: paralyzed from my eyes to my feet) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were not reported.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to RSV vaccine.     The company considered the guillain barre syndrome and paralysis to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 09-AUG-2025  This case was reported by a patient via interactive digital media. The patient stated the Respiratory Syncytial Virus vaccine almost killed her/him. The patient received Respiratory Syncytial Virus vaccine. and on new year's evening he/she was in the emergency room with severe, near fatal case of guillian-barre syndrome, paralyzed from his/her eyes to feet.  The first thing that they asked him/her in the emergency room was if he/she had gotten the Respiratory Syncytial Virus vaccine.  Feeding tube and months of rehabilitation later, to learn how to walk again, luckily, he/she survived.; Sender's Comments: A case of Guillain-Barre syndrome, less than 2 weeks after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Vaccine: RVX, RVX
Symptoms: Gait inability, Gastrointestinal tube insertion, Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillian-Barre Syndrome; paralyzed from my eyes to my feet; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 23-DEC-2024, the patient received RSV vaccine. In DEC-2024, less than 2 weeks after receiving RSV vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria GSK medically significant and life threatening) and paralysis (Verbatim: paralyzed from my eyes to my feet) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome and paralysis were not reported.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to RSV vaccine.     The company considered the guillain barre syndrome and paralysis to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 09-AUG-2025  This case was reported by a patient via interactive digital media. The patient stated the Respiratory Syncytial Virus vaccine almost killed her/him. The patient received Respiratory Syncytial Virus vaccine. and on new year's evening he/she was in the emergency room with severe, near fatal case of guillian-barre syndrome, paralyzed from his/her eyes to feet.  The first thing that they asked him/her in the emergency room was if he/she had gotten the Respiratory Syncytial Virus vaccine.  Feeding tube and months of rehabilitation later, to learn how to walk again, luckily, he/she survived.; Sender's Comments: A case of Guillain-Barre syndrome, less than 2 weeks after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Hypertension, Immediate post-injection reaction, Injected limb mobility decreased, Muscular weakness
Clinical narrative: As a 79 year old female, I received my third COVID19 Pfizer vaccine in my left arm on September (27), 2021. Immediately after the COVID19 Vaccine, I had a LARGE HUMERUS on my left arm. As the years past, I had pain in my LEFT ARM. My LEFT ARM became progressively WEAK that I couldn't USE and/or RAISE my LEFT ARM to pick up an empty cup. I was hospitalized on July 12, 2025 for (congestive heart failure/hypertension). While I was hospitalized, I give TWO BLOOD THINNERS in my stomach. Immediately, shrunk to half the size on my LEFT ARM. 9% of the PAIN on the LEFT ARM has gone. I can USE my LEFT ARM again "I think the COVID19 Pfizer Vaccine that I received in my LEFT ARM gave me a TINY BLOOD CLOT in my LEFT ARM which DIDN'T SHOW UP my MRI RESULTS. When I received the BLOOD THINNER while I was in the hospital, the BLOOD THINNER REMOVED the TINY BLOOD CLOT in my LEFT ARM!" I thought that I would have to live with the PAIN in my LEFT ARM after the COVID19 Vaccine. Please research if BLOOD THINNER is the SOLUTIONS to some of the PATIENTS that received COVID 19 Vaccine, and they are in PAIN.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: As a 79 year old female, I received my third COVID19 Pfizer vaccine in my left arm on September (27), 2021. Immediately after the COVID19 Vaccine, I had a LARGE HUMERUS on my left arm. As the years past, I had pain in my LEFT ARM. My LEFT ARM became progressively WEAK that I couldn't USE and/or RAISE my LEFT ARM to pick up an empty cup. I was hospitalized on July 12, 2025 for (congestive heart failure/hypertension). While I was hospitalized, I give TWO BLOOD THINNERS in my stomach. Immediately, shrunk to half the size on my LEFT ARM. 9% of the PAIN on the LEFT ARM has gone. I can USE my LEFT ARM again "I think the COVID19 Pfizer Vaccine that I received in my LEFT ARM gave me a TINY BLOOD CLOT in my LEFT ARM which DIDN'T SHOW UP my MRI RESULTS. When I received the BLOOD THINNER while I was in the hospital, the BLOOD THINNER REMOVED the TINY BLOOD CLOT in my LEFT ARM!" I thought that I would have to live with the PAIN in my LEFT ARM after the COVID19 Vaccine. Please research if BLOOD THINNER is the SOLUTIONS to some of the PATIENTS that received COVID 19 Vaccine, and they are in PAIN.
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Muscle spasms
Clinical narrative: Reported Symptoms: 10041408:SPASMS; Narrative: Other Relevant HX: Other: SPASMODIC MOVEMENT
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Cough, Decreased appetite, Lethargy
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10025482:MALAISE; Narrative: The patients daughter called a couple days after the vaccine was administered on 4/11/25 and said the patient was experiencing lethargic, weak, decreased appetite, and confusion after getting the vaccine and the plan was to just monitor over the weekend and a provider would check back in after the weekend and if anything got worse they were advised to seek medical attention. Patient has received several doses previously but all were Moderna, this was the first time the patient received Pfizer. Other Relevant HX: Other: COUGH; MALAISE
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10025482:MALAISE; Narrative: The patients daughter called a couple days after the vaccine was administered on 4/11/25 and said the patient was experiencing lethargic, weak, decreased appetite, and confusion after getting the vaccine and the plan was to just monitor over the weekend and a provider would check back in after the weekend and if anything got worse they were advised to seek medical attention. Patient has received several doses previously but all were Moderna, this was the first time the patient received Pfizer. Other Relevant HX: Other: COUGH; MALAISE
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Reported Symptoms: 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: WEAKNESS
Vaccine: COVID19
Symptoms: Retinal vascular thrombosis
Clinical narrative: Has developed blood clots in one of their eyes just days after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) (seriousness criterion medically significant). At the time of the report, RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Concomitant medication was not reported.  Patient took the vaccine and had developed blood clots in one of their eyes just days after receiving the vaccine back in 2021.   It was unknown if the patient experienced any additional symptoms/events.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-788794 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-788794:Reporter case
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) (seriousness criterion medically significant). At the time of the report, VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Concomitant medication was not reported.  It was reported that patient took the Covid-19 vaccine back in Fall of 2021 due to it being mandated by their job. After the patient took vaccine, a rapid decline in their vision was noticed and had slowly been losing their eyesight ever since to the point where they were seeing just glows of white.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-788797 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-788797:case for family member
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: felt achy/felt under the weather; lethargic/felt under the weather; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (he had slight fever and "could feel his immune system working). Past adverse reactions to the above products included Slight fever with Pfizer.    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 PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather). At the time of the report, PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was stated patient had better reaction to Moderna's vaccine over Pfizer's.   It was stated with Moderna's vaccine he had no fever but "felt under the weather". Probed was asking for details then it was stated patient felt achy and lethargic.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
Clinical narrative: spondyloarthropathy with ankylosing attributes or conditions; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 17Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild fibromyalgia" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "spondyloarthropathy with ankylosing attributes or conditions". Therapeutic measures were taken as a result of ankylosing spondylitis.  Clinical course: Medication was Pfizer covid vaccination from 2021. She has lots of things that happened after the vaccination that has now caused her lots of health problems and was on lots of medications. She wants to tell Pfizer what the vaccine did to her and her health for the last two, three or four years, clarifies as since 2021 since she got the second vaccination. She has very mild fibromyalgia intermittently that only affected her arm joint that was she confirms was diagnosed prior to the covid vaccine. She did not have immediate issues after the first dose then states she cannot delineate since the doses were weeks apart but immediately after the second dose, her entire body was on fire on the inside and every joint in her body awakened with pain, joints that she had never felt before. Her primary doctor had never heard of this. She went to the fibromyalgia website and there are hundreds of reports of fibromyalgia patients experiencing the same thing. No further details provided. Treatment: did not know what treatment to get. When querying outcome states she was taking biologic medication now since the covid vaccine caused spondyloarthropathy with ankylosing attributes or conditions, states she did not know what its called.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: not clarify when caller was diagnosed with Type 1 diabetes in relation to receiving vaccine.; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old 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: TYPE 1 DIABETES MELLITUS (medically significant), outcome "unknown", described as "not clarify when caller was diagnosed with Type 1 diabetes in relation to receiving vaccine.". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Clinical Course:It was reported that the patient had Type 1 Diabetes. She also mentioned that last year she got the Pfizer COVID 19 vaccine. Agent did not clarify that when patient was diagnosed with Type 1 diabetes in relation to receiving vaccine.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Didn't pay attention to the vaccine age limit. Patient was given the 12+ years Pfizer vaccine.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was expired on 5/17/2025
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident expired
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bundle branch block left, Electrocardiogram abnormal
Clinical narrative: New onset Left Bundle branch block
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RESIDENT RECIEVED EXPIRED VACCINE (EXP 6/14/25)
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RESIDENT RECIEVED EXPIRED VACCINE (EXP 6/14/25)
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Areflexia, Asthenia, Erythema, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Patient is having extreme difficulty walking. Has tingling in feet and legs, and swelling in ankles and feet. He is experiencing pain/weakness with walking; unsteady gait. He has redness on bottom of feet. His wife states that at the doctor's office today, he had no reflexes in his legs. Wife states that doctor has ordered for the patient to go to the hospital and be admitted for evaluation. Wife said dr. suspects that pt has Guillian Barre Syndrome.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Joint swelling, Pain, Paraesthesia, Peripheral swelling
Clinical narrative: Patient is having extreme difficulty walking. Has tingling in feet and legs, and swelling in ankles and feet. He is experiencing pain/weakness with walking; unsteady gait. He has redness on bottom of feet. His wife states that at the doctor's office today, he had no reflexes in his legs. Wife states that doctor has ordered for the patient to go to the hospital and be admitted for evaluation. Wife said dr. suspects that pt has Guillian Barre Syndrome.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RESIDENT RECIEVED EXPIRED VACCINE (EXP 6/14/25)
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: RESIDENT RECIEVED EXPIRED VACCINE (EXP 6/14/25)
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Ammonia, Chest X-ray abnormal, Full blood count, Hypotension
Clinical narrative: Admitted to Nursing  Home on Monday  8/18/25 s/p hospitalization for aspiration pneumonia. Requested a COVID and PNA vaccine on admit.  Covid vaccine available and resident had completed treatment for pneumonia and stable. Covid Comirnaty 24/25 vaccine given on 8/18/25 to right deltoid.  Friday 8/22/25 she was hypotensive, lethargic.  Labs and urine and chest x-ray obtained. WBCs were 17 on lab work and chest x-ray still shows right middle lobe pneumonia (possibly not fully resolved from previous infection). Antibiotics and IV fluids started on 8/23/25. Sent her to the ER for failed outpatient treatment and resident admitted for inpatient hospitalization for treatment of pneumoina, AKI r/t fluid volume depletion and leukocytosis.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Hypovolaemia, Lethargy, Leukocytosis, Metabolic function test, Pneumonia
Clinical narrative: Admitted to Nursing  Home on Monday  8/18/25 s/p hospitalization for aspiration pneumonia. Requested a COVID and PNA vaccine on admit.  Covid vaccine available and resident had completed treatment for pneumonia and stable. Covid Comirnaty 24/25 vaccine given on 8/18/25 to right deltoid.  Friday 8/22/25 she was hypotensive, lethargic.  Labs and urine and chest x-ray obtained. WBCs were 17 on lab work and chest x-ray still shows right middle lobe pneumonia (possibly not fully resolved from previous infection). Antibiotics and IV fluids started on 8/23/25. Sent her to the ER for failed outpatient treatment and resident admitted for inpatient hospitalization for treatment of pneumoina, AKI r/t fluid volume depletion and leukocytosis.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Treatment failure, Urine analysis, White blood cell count increased
Clinical narrative: Admitted to Nursing  Home on Monday  8/18/25 s/p hospitalization for aspiration pneumonia. Requested a COVID and PNA vaccine on admit.  Covid vaccine available and resident had completed treatment for pneumonia and stable. Covid Comirnaty 24/25 vaccine given on 8/18/25 to right deltoid.  Friday 8/22/25 she was hypotensive, lethargic.  Labs and urine and chest x-ray obtained. WBCs were 17 on lab work and chest x-ray still shows right middle lobe pneumonia (possibly not fully resolved from previous infection). Antibiotics and IV fluids started on 8/23/25. Sent her to the ER for failed outpatient treatment and resident admitted for inpatient hospitalization for treatment of pneumoina, AKI r/t fluid volume depletion and leukocytosis.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abnormal uterine bleeding, Bipolar disorder, Depression, Echocardiogram, Electrocardiogram
Clinical narrative: PFIZER #1 3/13/2021 PFIZER #2 4/5/2021 PFIZER #3 12/29/2021 DEVELOPED WORSENED ANXIETY DEPRESSION BIPOLAR SYMPTOMS REQUIRING VENLAFAXINE AND LAMICTAL.  DEVELOPED DYSFUNCTIONAL UTERINE BLEEDING AND POST EXERTIONAL MALAISE.  DIAGNOSIS POST VACCINE INJURY SYNDROME.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging heart, Malaise, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative
Clinical narrative: PFIZER #1 3/13/2021 PFIZER #2 4/5/2021 PFIZER #3 12/29/2021 DEVELOPED WORSENED ANXIETY DEPRESSION BIPOLAR SYMPTOMS REQUIRING VENLAFAXINE AND LAMICTAL.  DEVELOPED DYSFUNCTIONAL UTERINE BLEEDING AND POST EXERTIONAL MALAISE.  DIAGNOSIS POST VACCINE INJURY SYNDROME.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient lost consciousness about 15mintues after getting the covid vaccine.  Her parents were standing right next to her and caught her and lay her on the pharmacy waiting area floor.  She regained consciousness in a few seconds and was back to normal.  She was given water and later her father got her gatorade.  She rested in the pharmacy waiting area for about 15minutes and said she was feeling much better and left with her parents afterwards.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal detachment, Retinal tear, Vitrectomy, Vitreous detachment
Clinical narrative: I?ve had viscous separation and retinal tear and detachments in both eyes followed by a vitrectomy in both eyes.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site warmth, Malaise, Urticaria
Clinical narrative: I got a large welt ("COVID Arm") on the left arm at the site of injection. It was warm to the touch and itchy and has lasted for at least 3 days. I also felt very ill (similar to when I had COVID) on the day after my vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Angina pectoris, Electrocardiogram, Mechanical urticaria, Urticaria
Clinical narrative: Urticaria, dermatographia, heart pain, heat interested, hives
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria thermal
Clinical narrative: Urticaria, dermatographia, heart pain, heat interested, hives
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Brain fog, Constipation, Dizziness, Fatigue
Clinical narrative: Rapid heart rate, sudden drop of blood pressure, lightheadedness,  headaches, nausea, constipation,  fatigue, spinal tumor, brain fog
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Nausea, Neoplasm
Clinical narrative: Rapid heart rate, sudden drop of blood pressure, lightheadedness,  headaches, nausea, constipation,  fatigue, spinal tumor, brain fog
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: COVID 2x; COVID 2x; COVID 2x; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old 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 included: "smoker" (ongoing), notes: long time. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "COVID 2x". Clinical course: The patient had COVID 2x but had only 1 shot. The reporter asked if it is possible to get 2nd, 3rd & booster shots. Also, the patient lives in a personal care home with a lot of disabled folks who always seem to be 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: COVID-19, Drug ineffective
Clinical narrative: poor covid performance; poor covid performance; 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 "poor covid performance".  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: I have COVID and I wanted to get Paxlovid but I can't afford it; I have COVID and I wanted to get Paxlovid but I can't afford it; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jun2025 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 "I have COVID and I wanted to get Paxlovid but I can't afford it".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Caused vomiting for one day afterwards. Reporting for safety reasons.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Bradycardia, Brain natriuretic peptide, C-reactive protein, Cardiac monitoring abnormal
Clinical narrative: chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Chills, Dyspnoea, Echocardiogram normal, Fatigue
Clinical narrative: chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Positron emission tomogram, Positron emission tomogram normal, Pulse abnormal
Clinical narrative: chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Troponin, Ventricular extrasystoles, Ventricular tachycardia
Clinical narrative: chills that evening; woke up next AM with EXTREME fatigue & SOB; vitals - Bradycardia (pulse @ 40-50 / normally around 100), and elevated blood pressure. (am former RN; own high quality monitoring equipment). Chose not to go to Emerg Rm; couldn't get appt to see own cardiologist. Monitored self for weeks - with abnormal pulse & hypertensive B/P inconsistent, yet persisting; more infrequent as weeks elapsed. Finally saw cardiac NP. Put on Holter monitor; result - nonsustained tachycardia with increased PVC's. Cardiologist ordered labwork, cardiac US, result: increased pulmonary hypertension; Pet CT/Stress Test, result: normal. Rx prescribed: metoprolol. Cardiac MRI to be scheduled. status currently being evaluated. Initial symptoms of reaction to vaccine also included occasional nausea and heart palpitations. This was my 10th COVID vaccine; chose to get it because of CDC recommendations. Symptoms that still persist are fatigue and shortness of breath, but they have improved.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Unknown. Report is made after review of medical record by medical examiner. Unknown if recent vaccination had any effect of cause of death which is reported as Atherosclerotic and Hypertensive Cardiovascular Disease with Other significant conditions: diabetes mellitus, hypothyroidism, smoking, and chronic ethanol use. No autopsy was performed.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Upper L arm red, swollen, and painful
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid cyst, Eyelid cyst removal, Eyelid discolouration, Oedema peripheral, Swelling of eyelid
Clinical narrative: Armpit swelled the size of an orange after dose 1. After does 2 I developed cysts on both eyelids. They swelled up and turned purple. I had to get the cysts surgically removed. Terrible reaction to Covid vaccine in BOTH eyes. Surgery needed.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Loss of personal independence in daily activities
Clinical narrative: Guillain Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-AUG-2025 This case was reported by the patient's friend's wife via interactive digital media. A healthy friend had just got guillain barre syndrome after the first shot.  He could not even put on his own socks.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingles vaccine, in a male patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 024M20A, 017E21A and 033K21-2A) for COVID-19 prophylaxis.     Concurrent medical conditions included Lupus syndrome (Lupus).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, ARTHRALGIA (Caller stated that after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved.            No concomitant medication was reported. After each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.   This case was linked to MOD-2025-788866 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: after each COVID vaccine her shins and joints ache for 8-10 hours; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7143C and AS7180B) for COVID-19 prophylaxis.     Concurrent medical conditions included Lupus syndrome (Lupus).   On 14-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-May-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours). At the time of the report, ARTHRALGIA (after each COVID vaccine her shins and joints ache for 8-10 hours) had resolved.            No concomitant medication was reported. After each COVID vaccine her shins and joints ache for 8-10 hours. She thought it was just her body trying to make antibodies. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-788866 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 68-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.            No concomitant medications provided by the reporter. It was reported that the patient received six different vaccines in past and patient had COVID. Patient received the older strain vaccines, but he wanted the new one. It was reported that patient inquired about obtaining the most current Moderna COVID-19 vaccine before traveling internationally and he would be taken treatment medication Paxlovid if require. No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Mild inflammation on his knee after having the Novavax vaccine; This non-serious initial spontaneous report was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00632) and concerns an elderly Male who experienced "MILD INFLAMMATION ON HIS KNEE AFTER HAVING THE NOVAVAX VACCINE" after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 02-Oct-2024.  At the time of the report, the outcome of the Arthritis was Recovered/Resolved.  A few discrepancies were identified in the source document. Patient's age group was reported as "Adult" but was captured as "Elderly" according to the reported date of birth. The Novavax vaccination information reported for the 'Body Site Location' of the product administration was provided as "Left". Left arm was conservatively selected and will be confirmed with the query sent to the consumer.; Sender's Comments: This Male of an unspecified age experienced Arthritis after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Arthritis was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Arthritis is considered Possible.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Patient stopped by the pharmacy on 08/26/2025 and asked to me to report his side effects of Spikevax vaccine given on 08/17/2025. Patient states he had sever exhaustion, headache, body aches, and loss of appetite.  Side affects subsited without medical intervention.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Diarrhoea, Hallucination, Nausea, Vomiting
Clinical narrative: Patient husband stopped by the pharmacy and expressed that both him and his wife experienced side affects post receiving Spikevax vaccine on 08/14/2025. Per husband patient experienced diarrhea, and nausea accompanied by throwing up. In addition, patient had some cognitive side effects, per husband, patient had "loss of time and reality". Patient was hilucinating and talking about their daughter as if she was still 3 years old.  Patient states that the side affects subsited without any medical intervention.