chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site pain
Clinical narrative: Patient came back on 8/8/25 and showed the pharmacist the bruise , about the size of nickel ,on his injection site . He said  this time he bled after the injection . He said the pain has subsided on 8/8/25 when he came in .
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Butterfly rash, Lymphadenopathy, Systemic lupus erythematosus
Clinical narrative: At time of second vaccination in January 2021, I had extreme bone pain in forearms, thigh bones, and hips. My lymph nodes later enlarged and stayed swollen for months. About 1 year later I developed  severe joint pain in multiple joints with a red butterfly rash. 5 years later and I have been diagnosed with SLE.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration, Cardiac assistance device user, Endotracheal intubation, Fatigue, Impaired driving ability
Clinical narrative: Listed in first page of this form, I suffered a life changing cardiac episode.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Resuscitation, Sudden cardiac death
Clinical narrative: Listed in first page of this form, I suffered a life changing cardiac episode.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered, Injection site bruising, Injection site discomfort
Clinical narrative: Administration error regarding Prevnar 20. Patient received Prevnar 20 on 11/28/23. An additional dose of Prevnar 20 was administered on 08/15/2025. Patient stated she experienced some discomfort and bruising at the injection site that has since improved.  No further issues post administration.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Central serous chorioretinopathy, Dermatitis, Eczema, Fluorescence angiogram
Clinical narrative: Loss of vision right eye.  Central Serous Retinopathy.  No treatment available.  Severe Eczema, dermatitis.  Taking Rinvoq daily indefinitely.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy thyroid gland abnormal, Blood thyroid stimulating hormone decreased, Thyroiditis subacute
Clinical narrative: Suffered side effects beginning October 2024 and on December 27, 2024, TSH level dramatically dropped to 0.09. (Note: After 4 previous shots with no noted side effects from the Pfizer vaccine, it is worth noting the FDA approved and updated the mRNA formula for Covid-19 vaccines on August 22, 2024, and nearly one month before I received my 5th Covid-19 vaccine.  A vaccine, due to the FDA approved formula change, caused me to experience highly devastating symptoms associated with the condition known as subacute thyroiditis, a rare but potential side effect of the latest and formula-updated Covid-19 vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea, Eye pruritus, Eyelid margin crusting
Clinical narrative: A week after the second dose, I began experiencing allergies. Although at the time I was not aware it was allergies due to never having allergies. My eyes began itching really bad. I experienced eye crust, difficulty breathing and angioedema on my face. March 2, 2022 I experienced my anaphylactic reaction, followed by another one March 3, 2022. Ever since March, I've experienced multiple idiopathic anaphylactic reactions.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: A week after the second dose, I began experiencing allergies. Although at the time I was not aware it was allergies due to never having allergies. My eyes began itching really bad. I experienced eye crust, difficulty breathing and angioedema on my face. March 2, 2022 I experienced my anaphylactic reaction, followed by another one March 3, 2022. Ever since March, I've experienced multiple idiopathic anaphylactic reactions.
Age: 53.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Arthralgia, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient has a red rash on left arm around injection sites about the size of a fist. Patient also reports a little warmth on touching rash. Patient has not reported any swelling with rash but does have some shoulder pain associated with it
Age: 0.5
Sex: F
Vaccine: COVID19, MMR
Symptoms: Immediate post-injection reaction, Infant irritability, Injection site erythema, Injection site rash, Injection site urticaria
Clinical narrative: Immediately fussy, within 8-10 minutes started developing rash, pink wheals on left medial thigh concerning for urticaria, pink papules on right buttocks, red patch on dorsum of left toes. Fussiness and rash improved during observation with pink patch remaining on left inner thigh. Observed in clinic for 20 minutes total. No dyspnea, vomiting, or other symptoms of anaphylaxis.  Advised home administration of cetirizine which family administered. I (Dr.) followed up 3 hours later with family via phone, she was doing well, rash improving. She had a separate visit to the ER 8/15/25 for high fever, and on 8/18/25 was diagnosed with Roseola.
Age: 0.5
Sex: F
Vaccine: COVID19, MMR
Symptoms: Papule, Rash, Roseola
Clinical narrative: Immediately fussy, within 8-10 minutes started developing rash, pink wheals on left medial thigh concerning for urticaria, pink papules on right buttocks, red patch on dorsum of left toes. Fussiness and rash improved during observation with pink patch remaining on left inner thigh. Observed in clinic for 20 minutes total. No dyspnea, vomiting, or other symptoms of anaphylaxis.  Advised home administration of cetirizine which family administered. I (Dr.) followed up 3 hours later with family via phone, she was doing well, rash improving. She had a separate visit to the ER 8/15/25 for high fever, and on 8/18/25 was diagnosed with Roseola.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Fatigue, Flushing, Pain in extremity
Clinical narrative: she experienced flushing from her neck to waist; Increased blood pressure; sore arm; Tiredness; This serious case was reported by a consumer via call center representative and described the occurrence of flushing in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included propafenone (Rythmol).   On 07-JUL-2025, the patient received the 1st dose of Shingrix. On 09-JUL-2025, 2 days after receiving Shingrix, the patient experienced flushing (Verbatim: she experienced flushing from her neck to waist) (serious criteria hospitalization) and increased blood pressure (Verbatim: Increased blood pressure) (serious criteria hospitalization). In JUL-2025, the patient experienced pain in arm (Verbatim: sore arm) and tiredness (Verbatim: Tiredness). The outcome of the flushing and increased blood pressure were unknown and the outcome of the pain in arm and tiredness were resolved.   It was unknown if the reporter considered the flushing, increased blood pressure, pain in arm and tiredness to be related to Shingrix.     The company considered the flushing and increased blood pressure to be unrelated to Shingrix. It was unknown if the company considered the pain in arm and tiredness to be related to Shingrix.   Additional Information: GSK receipt date: 05-AUG-2025 The reporter was the patient who received her first dose of Shingrix and had a sore arm and felt tired. On Wednesday morning, she woke up with flushing from her neck to waist and an elevated blood pressure of 180/88. She went to the emergency room. She was also admitted to the hospital twice so far for flushing and high blood pressure.  The first time was from 14th JUL 2025 to 18th JUL 2025 and the second was from the following Tuesday to Thursday.; Sender's Comments: A case of Blood pressure increased and Flushing, 2 days after receiving Shingrix in a 78-year-old female patient.  Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (age).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Dysstasia, Gait inability, Guillain-Barre syndrome, Loss of personal independence in daily activities
Clinical narrative: Guillain Barre syndrome; There is also a period of time that she does not remember; This serious case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date).   On 23-AUG-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant) and memory loss (Verbatim: There is also a period of time that she does not remember). The outcome of the guillain barre syndrome and memory loss were unknown.   It was unknown if the reporter considered the guillain barre syndrome and memory loss to be related to Shingrix.     The company considered the guillain barre syndrome to be unrelated to Shingrix. It was unknown if the company considered the memory loss to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-AUG-2025 Reporter was the patient who received her second dose of Shingrix on 23rd August 2024. She stated that she was hospitalized from October 2024 to November 2024.  She was diagnosed with Guillain Barre syndrome.  She could not walk and stand at that time.  There was also a period that she did not remember.  Today (on the day reporting) she still cannot walk, she cannot put on her shoes, and was in a long term care facility.; Sender's Comments: A case of Guillain-Barre syndrome, an unknown time after receiving Shingrix, in a 63-year-old female 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.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: proved to be deathly allergic to the COVID shot; This 69-year-old male subject was involved in an other study and received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot).   No Medical History information was reported.    On an unknown date, the patient received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. In 2022, the patient experienced ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot) (seriousness criterion medically significant). At the time of the report, ALLERGY TO VACCINE (proved to be deathly allergic to the COVID shot) outcome was unknown.        The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) was unknown.   DCP-ID was reported as withheld id# with DCP name: 2025 Respiratory ATU Tracking Survey - CONSUMER.  No concomitant medication was reported. It was unknown if the subject had allergies to medications, food and other products.  Reporter stated that the subject provided a vague note that the subject proved to be allergic to the COVID shot when the subject took it.  It was unknown if the event caused the subject to seek medical care. It was unknown if there were any other factors that could have led to the adverse event. It was unknown if the subject had experienced a similar event in the past.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-788495 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-788495:Same Report, Different patient
Sex: M
Vaccine: COVID19
Symptoms: Cardiac ventricular thrombosis
Clinical narrative: developed a blood clot in his heart caused by the Moderna Covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    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 CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) (seriousness criterion medically significant). At the time of the report, CARDIAC VENTRICULAR THROMBOSIS (developed a blood clot in his heart caused by the Moderna Covid vaccine) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was reported that patient had developed a blood clot in his heart caused by the Moderna Covid vaccine. He was currently seeing a heart specialist. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Lichen planus, Lichen sclerosus
Clinical narrative: lichen planus; lichen sclerosis; This spontaneous case was reported by a consumer and describes the occurrence of LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis). At the time of the report, LICHEN PLANUS (lichen planus) and LICHEN SCLEROSUS (lichen sclerosis) had resolved with sequelae.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Atrial fibrillation, Pneumonia
Clinical narrative: atrial fibrillation; Pneumonia; This 76-year-old female subject was enrolled in an open label study titled A phase 3b, randomized, open label, multi-country,multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) 120 µg on 14-AUG-2025, for prophylaxis.   On 30-DEC-2024, not applicable after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 pneumonia (Verbatim: Pneumonia). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 atrial fibrillation (Verbatim: atrial fibrillation) on 14-AUG-2025 with serious criteria of hospitalization. The outcome of pneumonia was resolved on 12-JAN-2025. The outcome(s) of the additional event(s) included atrial fibrillation (resolved).   The investigator considered that there was no reasonable possibility that the pneumonia and atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E.   The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E.   Linked case(s) involving the same subject:  US2025105118   GSK Initial receipt date: 14-AUG-2025, 15-AUG-2025  The end date of event atrial fibrillation was reported as 2-JAN-2025.  AE (Adverse event) was not related to study treatment. SAE (Serious adverse event) was not Related to Study Participation Activities other than Study Treatment.  Hospital Admission date: 30-DEC-2024  Hospital Discharge date: 12-JAN-2025 Date event became serious for Pneumonia: 30-DEC-2024 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI) Date event became serious for atrial fibrillation: 31-DEC-2024.; Sender's Comments: A case of  Atrial fibrillation, Less than a day after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 76-year-old female subject. Report is inconsistent with causal relation to the vaccine product. US-GSK-US2025105118:
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Off label use
Clinical narrative: She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dose of the Novavax Covid vaccine in March 2025; She had never been vaccinated previously with any other Covid vaccine, and she only ever got one dose of the Novavax Covid vaccine in March 2025; This non-serious initial spontaneous report from withheld was reported by a consumer or other non-health professional via contact center (MI No. NOV25-00601)  and concerns a 47- year-old Female  who reported "She had never been vaccinated previously with any other covid vaccine, and she only ever got one dose of the Novavax covid vaccine in march 2025" (Incomplete course of vaccination) and "She had never been vaccinated previously with any other covid vaccine, and she only ever got one dose of the Novavax covid vaccine in march 2025" (Off label use) after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 22-Mar-2025.  At the time of reporting, the outcome of the Incomplete course of vaccination and Off label use was Recovered/Resolved.; Sender's Comments: This 47-year-old Female experienced Incomplete course of vaccination and Off label use after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Incomplete course of vaccination and Off label use were 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 Incomplete course of vaccination and Off label use is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Mammogram
Clinical narrative: lymph node enlargement; Generic flu like symptoms; This is a spontaneous report received from a Nurse.  A female patient received BNT162b2 (BNT162B2), in 2021 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: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph node enlargement"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Generic flu like symptoms". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500165860 same patient, different dose;US-PFIZER INC-202500165859 same patient, different dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid; All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-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: "auto immune issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE (All my shots are through Pfizer)), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "All my shots are through Pfizer/got it (COVID) this weekend/prescribed Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient was just prescribed Paxlovid. Maybe she got crazy symptoms and she not thinking. 5 1/2 years, she has not had COVID and suddenly she was at a wedding, and she thought that's how she got it this weekend. She hasn't had anything for 5 1/2 years thanks to Pfizer. But you know being at a wedding with 5 million people around me and no masks she guess she can see how it happened. All my shots are through Pfizer, every one of them. It's just she was super high risk she have auto immune issues.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: pain at injection site; fever; tiredness; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), in arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis", start date: Feb2017 (ongoing); "Interstitial lung disease", start date: Feb2017 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".
Age: 31.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Acne, Anorectal discomfort, Erythema, Exercise tolerance decreased, Pelvic discomfort
Clinical narrative: Rash on scalp with puss mixed with clear fluid. Rash on both hands on the back of them. Brief flash Rash on forearms.
Age: 31.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Penile burning sensation, Pruritus, Rash
Clinical narrative: Rash on scalp with puss mixed with clear fluid. Rash on both hands on the back of them. Brief flash Rash on forearms.
Age: 31.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Rash, Skin discharge
Clinical narrative: Rash on scalp with puss mixed with clear fluid. Rash on both hands on the back of them. Brief flash Rash on forearms.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pharmacist gave wrong vaccine; Arexvy in pregnancy; Arexvy in pregnancy; Arexvy at 35 years; anxiety; This non-serious prospective pregnancy case was reported by a consumer and described the occurrence of anxiety in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number withheld rx#, expiry date 25-OCT-2025) for prophylaxis.   On 07-AUG-2025, the patient received the 1st dose of Arexvy. On 07-AUG-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Pharmacist gave wrong vaccine), vaccine exposure during pregnancy (Verbatim: Arexvy in pregnancy), drug use in unapproved population (Verbatim: Arexvy in pregnancy) and inappropriate age at vaccine administration (Verbatim: Arexvy at 35 years). In AUG-2025, the patient experienced anxiety (Verbatim: anxiety). The outcome of the anxiety was not reported and the outcome of the wrong vaccine administered, vaccine exposure during pregnancy, drug use in unapproved population and inappropriate age at vaccine administration were not applicable.   It was unknown if the reporter considered the anxiety to be related to Arexvy.     It was unknown if the company considered the anxiety to be related to Arexvy.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Estimated Delivery/Due date: 24-SEP-2025 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-AUG-2025 Vaccine not approved for Pregnant women. Pharmacist gave wrong vaccine and administered to 35 years pregnant patient which led to wrong vaccine administered, vaccine exposure during pregnancy, drug use in unapproved population and inappropriate age at vaccine administration. Concerns about premature delivery and concerns about protection for newborn, and her anxiety clear pharmacist error. Had 120-dollar co pay as well and newborn still may need Mab.  Swelling concern for her unborn post care follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: pain at injection site; fever; tiredness; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 2, single (Lot number: EW0150) at the age of 74 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis", start date: Feb2017 (ongoing); "Interstitial lung disease", start date: Feb2017 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 13Mar2021, for COVID-19 Immunization, reaction(s): "tiredness", "pain at injection site", "fever". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at injection site"; PYREXIA (non-serious), outcome "unknown", described as "fever"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 74-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. Vaccination history included: Covid-19 vaccine (Primary immunization series complete). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: COVID-19: positive.  Clinical course: During an inbound call for financial assistance, the patient, stated, "she felt real lousy and for the first time, in her entire life this is the first time she tested positive for COVID. She dodged all the bullets but today. She worked part-time. She left there without the medicine, and she would still like to get it cause she felt really lousy, and she just started feeling sick yesterday." When gathering her demographics to enroll in the program, stated, her voice, she had got another issue with (inaudible) her throat was really, really sore." After playing the patient authorization for electronic income verification recording, stated, "Yes, she did, she was confused but she don't care if she was confused, she would be honest with them, Pfizer has saved her life. She have had all the vaccines that she could possibly get, and She had never caught it until today, in 5 years. She was a little shocked, she thought she was going to get away with not getting it". The coughing was coming in now...she need that Paxlovid, she need the Paxlovid, she need it". Later stated, "as long as she don't feel sick." Towards the end of the call, stated," pretty soon the symptoms just started yesterday so. She wanted to get that drug." When offering to transfer the call to the DSU, stated, "Briefly, her throat was very sore, but she can sing.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Echocardiogram normal, Headache, Hypertensive emergency, Troponin increased, Vision blurred
Clinical narrative: she was in a hypertensive emergency/hypertension /headache/ blurred vision; Her Troponin level is elevated; This serious case was reported by a physician via call center representative and described the occurrence of hypertensive emergency in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number D2343, expiry date 31-JAN-2026) for prophylaxis.   On 28-JUL-2025 15:00, the patient received Menveo (intramuscular). On 29-JUL-2025 03:00, 1 days after receiving Menveo, the patient experienced hypertensive emergency (Verbatim: she was in a hypertensive emergency/hypertension /headache/ blurred vision) (serious criteria hospitalization and GSK medically significant) and troponin increased (Verbatim: Her Troponin level is elevated) (serious criteria hospitalization). The outcome of the hypertensive emergency and troponin increased were not resolved.   The reporter considered the hypertensive emergency and troponin increased to be related to Menveo.     The company considered the hypertensive emergency and troponin increased to be related to Menveo.   Additional Information: GSK Receipt Date: 05-AUG-2025 and 06-AUG-2025 The Medical Doctor reported that her patient had blurring vision and headaches shortly after receiving the dose of Menveo vaccine.  The reporter stated 12 hours after the vaccination she was in a hypertensive emergency at the Emergency Room with hypertension and hospitalized for a week. Her blood pressure had risen from 112/80 to over 200/110 and her Troponin level was elevated but the echogram is normal.  The doctor requested as soon as possible any report of hypertension extremely refractory with no response to medication, and blurry vision in adolescent or young adults after Menveo shots. The need to find an urgent cause to this situation; Sender's Comments: A case of Hypertensive emergency and troponin increased, 1 days after receiving Menveo. in a 18-year-old female patient Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: I was knocked out for 2 days; This serious case was reported by a consumer via interactive digital media and described the occurrence of loss of consciousness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced loss of consciousness (Verbatim: I was knocked out for 2 days) (serious criteria GSK medically significant). The outcome of the loss of consciousness was resolved (duration 2 days).   It was unknown if the reporter considered the loss of consciousness to be related to Shingles vaccine.     The company considered the loss of consciousness to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-AUG-2025 This case was reported by a patient via interactive digital media. The patient got the 1st shot on Tuesday and it kicked patient's butt.  The patient was knocked out for 2 days and would definitely take off from work for the 2nd shot.; Sender's Comments: A case of Loss of consciousness, unknown time after receiving Shingles 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.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Glucose urine present, Lethargy, Pollakiuria, Thirst
Clinical narrative: We collectively obtained the COVID vaccine in preparation of travel from (withheld) to (withheld) on 11/3. During travel around 11/6-11/7 patient began presenting symptoms of extreme thirst and frequent urination and was very lethargic and began losing weight. Unbeknownst to us these are classic signs of diabetes for someone who is in a state of diabetic ketoacidosis. U
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: We collectively obtained the COVID vaccine in preparation of travel from (withheld) to (withheld) on 11/3. During travel around 11/6-11/7 patient began presenting symptoms of extreme thirst and frequent urination and was very lethargic and began losing weight. Unbeknownst to us these are classic signs of diabetes for someone who is in a state of diabetic ketoacidosis. U
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain
Clinical narrative: Patient has redness at injection site and surrounding area about the size of a baseball.  Patient states the area is tender to touch.  She is also complaining of itching.  She is taking tylenol and motrin with minimal benefit.  She is also complaining that it is painful to lift the arm. Consulted patient to take benadryl for the itching and try alternating with warm and cold compresses for pain relief.   Also let ptnt know let MD know if pain worsens or is not relieved within 72 hours.
Vaccine: MENB
Symptoms: Immunodeficiency
Clinical narrative: Immunocompromised status after Bexsero 2 doses; This serious case was reported by a physician via call center representative and described the occurrence of immunocompromised in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced immunocompromised (Verbatim: Immunocompromised status after Bexsero 2 doses) (serious criteria GSK medically significant). The outcome of the immunocompromised was unknown.   It was unknown if the reporter considered the immunocompromised to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the immunocompromised to be unrelated to 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 :07-AUG-2025 and 08-AUG-2025 Physician reported that a patient had received 2 doses of Bexsero and later became immunocompromised. The reporter wanted to ask should they receive additional dose(s) of Bexsero or not. The reporter consented to follow up.; Sender's Comments: A case of Immunodeficiency, unknown date after Bexsero and Bexsero Pre-Filled Syringe Device, in a patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Sex: M
Vaccine: COVID19
Symptoms: Haematological neoplasm
Clinical narrative: blood cancer; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOLOGICAL NEOPLASM (blood cancer) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HAEMATOLOGICAL NEOPLASM (blood cancer) (seriousness criterion medically significant). At the time of the report, HAEMATOLOGICAL NEOPLASM (blood cancer) had resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was stated that patient has blood cancer they did not knew when it started or if the vaccine impacted it in any ways. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal, Pyrexia, Tremor
Clinical narrative: shaking; felt awful and didn't get out of bed; pretty down; feeling feverish; This spontaneous case was reported by a pharmacist and describes the occurrence of TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish) in a 54-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Pulmonary disorder.    In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish). In 2024, TREMOR (shaking), FEELING ABNORMAL (felt awful and didn't get out of bed), DEPRESSED MOOD (pretty down) and PYREXIA (feeling feverish) had resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient not had other vaccines within the past 4 weeks. The patient was felt feverish, shaky and pretty down for 17 hours. She felt awful and didn't get out of bed but then was back normal. It was unknown if the patient experienced any additional symptoms or events.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for the covid spike protein which is very high; tested positive for the covid spike protein which is very high; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for the covid spike protein which is very high". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: came down with COVID/had the flu or something/at home tests, and they both came back positive, and then I had the razor blade sensation in my throat; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Aug2025 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Primary DOSE SERIES complete (had the Pfizer vaccine in the past and never had a problem)), for COVID-19 immunization, reaction(s): "No adverse reaction ". The following information was reported: COVID-19 (non-serious) with onset 12Aug2025, outcome "unknown", described as "came down with COVID/had the flu or something/at home tests, and they both came back positive, and then I had the razor blade sensation in my throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Clinical course: During an inbound call for additional information regarding eligibility, the patient stated, I was calling regarding a conversation that I had last Friday with a representative from Pfizer regarding the Paxlovid antiviral medication.  Later, she stated she received the COVID booster on August 9, and on August 12, this past Tuesday, I came down with COVID. So I was kind of shocked to have that happen to me because I had the Pfizer vaccine in the past and never had a problem. This is the first time I've had COVID ever after confirming she had the booster and then came down with COVID, she stated, "Yeah. 3 days later, she came down with COVID, the Nimbus variant. I was kind of shocked. I thought maybe I had the flu or something, but then I did 2 at home tests, and they both came back positive, and then I had the razor blade sensation in my throat. The severe sore throat, and I looked up the information online, and they said there was a variation called the Nimbus variant. Have you ever heard of anybody getting COVID after they had the vaccine.  Later, she stated, she have received like many Pfizer vaccines over the years, and she was totally in shock that 3 days later, after she got the current booster shot, she came down with COVID. So she was not expecting that at all.   The information on the batch/lot number for BNT162b2 omicron (kp.2), BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cerebral infarction, Cerebrovascular accident, Pain in extremity
Clinical narrative: multiple strokes; inoperable brain blockage; asthma; a bit of arm pain after vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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. Vaccination history included: Covid 19 vaccine (has had multiple doses of the Covid 19 Vaccine every 6 months for a couple of years. Unknown dose number, Unknown manufacturer.), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "not recovered", described as "multiple strokes"; CEREBRAL INFARCTION (medically significant), outcome "not recovered", described as "inoperable brain blockage"; ASTHMA (non-serious), outcome "not recovered"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "a bit of arm pain after vaccines". Therapeutic measures were taken as a result of cerebrovascular accident, cerebral infarction, asthma.  Clinical information: On 18Aug2025, it was reported that caller stated patient had multiple strokes, had an inoperable brain blockage and asthma. Patient was taking multiple medications for her conditions and has had multiple doses of the Covid 19 Vaccine every 6 months for a couple of years, caller indicated a bit of arm pain after vaccines. Created AE due to existing conditions as well as interaction with other medications.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The events Stroke and Brain infarction are considered unrelated to the suspect drug, as it is explained by an alternative mechanism unrelated to the pharmacological action of the drug.  The impact of this report on the benefit/risk profile of the Pfizer product is  evaluated as part of Pfizer procedures for safety evaluation, including the review  and analysis of aggregate data for adverse events. Any safety concern identified as  part of this review, as well as any appropriate action in response, will be promptly  notified to regulatory authorities, Ethics Committees, and Investigators, as  appropriate
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy
Clinical narrative: Generic flu like symptoms; lymph node enlargement; This is a spontaneous report received from an Other HCP.  A female patient received BNT162b2 (BNT162B2), in 2022 as dose 2, 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), administration date: 2021, for COVID-19 Immunization, reaction(s): "Generic flu like symptoms", "lymph node enlargement". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Generic flu like symptoms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node enlargement".  Additional Information: Clarified today, 18Aug2025, is day caller made aware of adverse events. Clarified, there were 2 different side effects. Lymph node enlargement: When caller asked when this side effect started, caller states, there were 2 side effects, reporter was saying to caller, that would usually occur every time she got Covid vaccine, back in 2021, 2022, 2023. That is what reporter is guessing. This occurred when getting 2 dose primary series, occurring both with first and second doses. The lymph node enlargement required her to get a mammogram, and lasted about 6 months. Generic flu like symptoms: Clarified second side effect as, just generic  flu like symptoms, lasted about 4 days.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he got Covid after getting the Covid-19 vaccine 2 weeks ago; he got Covid after getting the Covid-19 vaccine 2 weeks ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Aug2025 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) all with onset Aug2025, outcome "unknown" and all described as "he got Covid after getting the Covid-19 vaccine 2 weeks ago". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram normal, Fatigue, Musculoskeletal chest pain, Pain
Clinical narrative: PATIENT RECEIVED VACCINE FRIDAY AFTERNOON. AT TIME OF VACCINE AND PRIOR PHONE CALL HE SEEMED NERVOUS ABOUT POTENTIAL SIDE EFFECTS BECAUSE HE HAD EXTREMELY SORE ARM AFTER RSV.  WE HAD THE OPINION THAT HE MAY HAVE BEEN MENTALLY COMPROMISED DUE TO SPEECH AND  BEHAVIOR. HE SAID HE FELT FINE FRIDAY BUT WOKE UP SATURDAY FEELING LOUSY(TIRED, ACHEY AND HAD CHEST PAIN) IN SPEAKING WITH ER THEY NOTED  FLU VACCINE ADMINISTERED BUT DID NOT LINK CHESTWALL PAIN SPECIFICALLY TO FLU VACCINE.  PATIENT HAS RECEIVED ANNUAL FLU SHOTS FOR MULTIPLE YEARS
Age: 78.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Erythema
Clinical narrative: patient came into pharmacy and showed us that his lower arm was red. it wasnt itchy, swollen, or hot to the touch though. he wondered if the redness couldve been caused by the vaccines. the pharmacist said to take a bendaryl or use benadryl cream if it became itchy or swollen and to contact his doctor.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: I gave the tetanus shot in the left arm and then proceeded to administer the flu shot in the Right arm. After injecting the flu shot, the patient said" I think you hit a nerve" He fainted. In 2 minutes, he woke up. I gave him orange juice, and water and an ice pack for his neck because he warm to the touch.