chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  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 "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19 included: Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac disorder, Heart rate abnormal, SARS-CoV-2 test
Clinical narrative: they were diagnosed with AFib; had issues with heart racing; cardiology issues; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 1, single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (Had received the , Moderna vaccine 3 times prior), for Covid-19 Immunization. The following information was reported: CARDIAC DISORDER (caused and prolonged hospitalization) with onset 2022, outcome "unknown", described as "cardiology issues"; HEART RATE ABNORMAL (caused and prolonged hospitalization) with onset 2022, outcome "unknown", described as "had issues with heart racing"; ATRIAL FIBRILLATION (caused and prolonged hospitalization, medically significant) with onset 2022, outcome "unknown", described as "they were diagnosed with AFib". The events "they were diagnosed with afib", "had issues with heart racing" and "cardiology issues" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: never tested positive for COVID at any time. Therapeutic measures were taken as a result of atrial fibrillation, heart rate abnormal, cardiac disorder.  Clinical course: Patient received the Pfizer vaccine on 16Sep2022. Had received the withheld vaccine 3 times prior. This was their first Pfizer vaccine. Patient claims they soon after had issues with heart racing and cardiology issues. Upon seeing an electrophysiologist, medications and monitoring they were diagnosed with AFib. No family history of AFib prior. Patient apparently never tested positive for COVID at any time. Events treatment included medication, three ablation procedures, pacemaker.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Apathy, Asthenia, Brain fog, Confusional state
Clinical narrative: Ever since about 7-10 days after 5/28/2021 vaccination, considerable persistent, unchanging and tinnitus -- horrible high-pitched piercing noise that never changes or ends  Throbbing headaches, dizziness and visual impairments, confused state, memory impairment, anxiety, vertigo, insomnia Constant fatigue, brain fog, lack of motivation, and have zero energy
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Insomnia, Memory impairment
Clinical narrative: Ever since about 7-10 days after 5/28/2021 vaccination, considerable persistent, unchanging and tinnitus -- horrible high-pitched piercing noise that never changes or ends  Throbbing headaches, dizziness and visual impairments, confused state, memory impairment, anxiety, vertigo, insomnia Constant fatigue, brain fog, lack of motivation, and have zero energy
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo, Visual impairment
Clinical narrative: Ever since about 7-10 days after 5/28/2021 vaccination, considerable persistent, unchanging and tinnitus -- horrible high-pitched piercing noise that never changes or ends  Throbbing headaches, dizziness and visual impairments, confused state, memory impairment, anxiety, vertigo, insomnia Constant fatigue, brain fog, lack of motivation, and have zero energy
Sex: M
Vaccine: HEP
Symptoms: Atrial septal defect, Cerebral ventricle dilatation, Chest X-ray, Echocardiogram, Electroencephalogram
Clinical narrative: Initially patient developed symptoms with a fever and head swelling after 4-30-25 with no fever or swelling initially after birth. By 5-4-25 he was diagnosed with Intraventricular hemorrhage of newborn Grade IV, Cerebral ventriculomegaly 5-4-25, Periventricular leukomalacia 5-12-25, seizures in newborn 5-18-25, post hemorrhagic hydrocephalus 5-23-25, patent foramen ovale 5-25-25, and feeding difficulties 6-5-25.
Sex: M
Vaccine: HEP
Symptoms: Endotracheal intubation, Feeding disorder, Intraventricular haemorrhage neonatal, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Initially patient developed symptoms with a fever and head swelling after 4-30-25 with no fever or swelling initially after birth. By 5-4-25 he was diagnosed with Intraventricular hemorrhage of newborn Grade IV, Cerebral ventriculomegaly 5-4-25, Periventricular leukomalacia 5-12-25, seizures in newborn 5-18-25, post hemorrhagic hydrocephalus 5-23-25, patent foramen ovale 5-25-25, and feeding difficulties 6-5-25.
Sex: M
Vaccine: HEP
Symptoms: Neonatal seizure, Periventricular leukomalacia, Posthaemorrhagic hydrocephalus, Pyrexia, Swallow study
Clinical narrative: Initially patient developed symptoms with a fever and head swelling after 4-30-25 with no fever or swelling initially after birth. By 5-4-25 he was diagnosed with Intraventricular hemorrhage of newborn Grade IV, Cerebral ventriculomegaly 5-4-25, Periventricular leukomalacia 5-12-25, seizures in newborn 5-18-25, post hemorrhagic hydrocephalus 5-23-25, patent foramen ovale 5-25-25, and feeding difficulties 6-5-25.
Sex: M
Vaccine: HEP
Symptoms: Swelling, Ultrasound head
Clinical narrative: Initially patient developed symptoms with a fever and head swelling after 4-30-25 with no fever or swelling initially after birth. By 5-4-25 he was diagnosed with Intraventricular hemorrhage of newborn Grade IV, Cerebral ventriculomegaly 5-4-25, Periventricular leukomalacia 5-12-25, seizures in newborn 5-18-25, post hemorrhagic hydrocephalus 5-23-25, patent foramen ovale 5-25-25, and feeding difficulties 6-5-25.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Acute stress disorder, Allergy test negative, Dermatitis contact, Food allergy, Skin burning sensation
Clinical narrative: Within days, started having allergic reactions to foods and skincare that had never caused reactions before in 42 years. Burning in my face, swelling in my face, hives over my arms, neck and chest. Went to emergency room for second reaction, not stopped by Benedryl. Symptoms match Mast Cell Activation Syndrome. I now have allergic reactions to stress and certain foods (although allergy tests show no allergy to foods). Controlled mostly with diet, the doctors I have seen don?t know anything about MCAS, so no treatment so far.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Swelling face, Urticaria
Clinical narrative: Within days, started having allergic reactions to foods and skincare that had never caused reactions before in 42 years. Burning in my face, swelling in my face, hives over my arms, neck and chest. Went to emergency room for second reaction, not stopped by Benedryl. Symptoms match Mast Cell Activation Syndrome. I now have allergic reactions to stress and certain foods (although allergy tests show no allergy to foods). Controlled mostly with diet, the doctors I have seen don?t know anything about MCAS, so no treatment so far.
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Asthenia, Immunisation reaction, Injection site rash, Injection site scar, Lethargy
Clinical narrative: Within 24 hours of receiving multiple vaccines (DTaP ? 1st dose, Pneumococcal ? 2nd dose, different product than prior), my child developed a severe adverse reaction. It began with an extremely bad rash at the vaccine site that quickly spread over his entire body. He developed a very high fever of 104?105°F and became so sick he could barely function ? lethargic, weak, and unable to engage in normal activity.  I contacted his clinic immediately and provided photos. Nurses and staff expressed alarm, stating they had ?never seen anything like this,? and instructed me to monitor him closely at home. The reaction was severe enough to leave a permanent scar at the injection site, still visible one year later.
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Loss of personal independence in daily activities, Malaise, Pyrexia, Rash
Clinical narrative: Within 24 hours of receiving multiple vaccines (DTaP ? 1st dose, Pneumococcal ? 2nd dose, different product than prior), my child developed a severe adverse reaction. It began with an extremely bad rash at the vaccine site that quickly spread over his entire body. He developed a very high fever of 104?105°F and became so sick he could barely function ? lethargic, weak, and unable to engage in normal activity.  I contacted his clinic immediately and provided photos. Nurses and staff expressed alarm, stating they had ?never seen anything like this,? and instructed me to monitor him closely at home. The reaction was severe enough to leave a permanent scar at the injection site, still visible one year later.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Syncope
Clinical narrative: A few minutes after administering the vaccine, the patient fainted. I had stepped back into the pharmacy to retrieve some documents when I heard her mother call for help. Her mother was able to prevent her from falling out of the chair she was sitting in. She was unconscious just briefly as she regained consciousness by the time I looked into the vaccination room.  We had her lay on the floor and I called 911 per protocol.  Prior to the paramedics arriving, the patient started to feel better, sat up, and sipped some water.  When the paramedics arrived, they took her blood pressure and blood sugar.  After monitoring her, they cleared her and the mother and patient decided against going to the emergency room.
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Product use in unapproved indication, Toothache
Clinical narrative: She began treatment with pneumococcal vaccination;  This literature report has been received from the authors of the published article and refers to a 44-year-old female patient.    The patient's medical history included childhood asthma, uncontrolled type 2 diabetes mellitus, osteomalacia with spontaneous rib fractures, Cushing's syndrome post-transsphenoidal pituitary resection, adrenocortical insufficiency, left lower lobe resection for mucinous adenocarcinoma in situ. The patient's concurrent conditions included asthma. The patient's concomitant medications included LAMA-LABA-ICS therapy and nasal irrigation.    On unspecified date, the patient received treatment with pneumococcal vaccination (unknown vaccine) (dose, strength, route of administration, lot #, and expiration date were not provided) as an asthma treatment (product use in unapproved indication).
Sex: M
Vaccine: HEP
Symptoms: Echocardiogram, Ejection fraction normal, Heart transplant, Hepatitis B surface antigen positive, Liver function test normal
Clinical narrative: HBsAg Negative at POD 412 Post Heart Transplant; HBV PCR Negative at POD 412 Post Heart Transplant; HBsAb Titer was 277.2 mIU/mL pre-Transplant and 449.8 mlU/mL One Year Post-Transplant; Initial report received on 19-Jun-2025.  This report was retrieved from the following publication:   A 71-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and on postoperative day (POD) 412 after heart transplant, the patient's hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) polymerase chain reaction (PCR) remained negative.  Medical history included advanced heart failure due to ischemic cardiomyopathy. The patient's pre-transplant hepatitis B surface antibody (HBsAB) titer was 277.2 mIU/mL.  No concomitant medications were reported.     Three years prior to transplant, the patient was vaccinated with the two-dose series of a hepatitis B vaccine HEPLISAV-B (lot numbers, expiration dates and NDC numbers not available).  On an unknown date, three years after receiving HEPLISAV-B, the patient received a heart from a donor who was Hepatitis B Virus (HBV) Nucleic Acid Test Positive (NAT), and hepatitis B core antibody (HBcAb) positive. The patient received one dose of hepatitis B immunoglobulin (HBIG) 20,000 units intravenously (IV) intraoperatively followed by 5,000 units IV daily for 7 days in addition to starting tenofovir alafenamide 25 mg by mouth daily on postoperative day (POD) O for approximately 1 year. HBsAg, HBsAb and HBV PCR were monitored every 3 months.   One-year post-transplant, and approximately 4 years after receiving HEPLISAV-B, the patient remained immune to HBV with an HBsAb titer of 449.8 mlU/mL. At POD 412 the patient's HBsAg and HBV PCR remained negative. Tenofovir alafenamide prophylaxis was discontinued on POD 448. Liver function tests (LFTs) were normal at baseline and stable post-transplant. His allograft function is stable with the most recently calculated ejection fraction of 68.5% measured by transthoracic echocardiography.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Antibody test positive, Echocardiogram, Ejection fraction normal, Heart transplant, Hepatitis B surface antibody positive
Clinical narrative: Vaccinated With One Dose of HEPLISAV-B and Then Received One Dose of ENGERIX-B; HBsAg Negative at POD 177 Post Heart Transplant; HBsAb Titer was 276.7 mIU/mL at Transplant and 267.1 mlU/mL Two Months Post-Transplant; Initial report received on 19-Jun-2025.  This report was retrieved from the following publication:   A 53-year-old female received one dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received one dose of recombinant hepatitis B vaccine ENGERIX-B approximately one year pre-heart transplant. She remained hepatitis b surface antigen (HBsAg) negative postoperative day (POD) 177.   Medical history included advanced heart failure due to arrhythmogenic right ventricular cardiomyopathy.   No concomitant medications were reported.     One year prior to transplant, the patient was vaccinated with one dose of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available).  One year prior to transplant, the patient was vaccinated with the second dose of a hepatitis B vaccine ENGERIX-B (lot number and expiration date not available).  On an unknown date, one year after receiving HEPLISAV-B, the patient received a heart from a donor who was HBsAg negative, hepatitis B core antibody (HBcAB) negative, and hepatitis B virus (HBV) nucleic acid test (NAT) positive. The patient was immune to HBV with a hepatitis B surface antibody (HBsAB) titer of 276.7 mIU/mL at the time of transplant. Of note, the donor was also hepatitis C (HCV) NAT positive for which patient completed a course of sofosbuvir/velpatasvir 400/100 mg 1 tablet by mouth daily for 12 weeks per institutional protocol. She also received entecavir 0.5 mg by mouth daily beginning on POD 2 for an anticipated duration of 1 year and monitoring plans for HBsAg monthly.  Two months post-transplant, the patient remained immune to HBV with an HBsAB titer of 267.1 mIU/mL. At POD 121 the patient remained HBsAg negative. At POD 177 she had normal liver function tests.  On an unknown date, the patient had a stable allograft function. On transthoracic echocardiograph, the patient had a calculated ejection fraction of 57.6%  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Asthma, Condition aggravated, Dyspnoea
Clinical narrative: breathing difficulty/ as the day progressed/ got worse; has asthma, that was exacerbated by a recent flu shot; Initial information received on 22-Jul-2025 regarding an unsolicited valid  serious case received from a consumer/non-healthcare profesisonal.  This case was linked to other case US-SA-2025SA214057 (Dupixent case)  This case involves a 77 years old male patient (65.45 kg) who had breathing difficulty/ as the day progressed/ got worse and has asthma, that was exacerbated by a recent flu shot after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma.  Concomitant medications included calcium; vitamin D3; chondroitin sulfate sodium, glucosamine hydrochloride, manganese gluconate, sodium borate decahydrate (glucosamine & chondoritin); and fish oil.  On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (Immunisation)  Information on the batch number was requested corresponding to the one at time of event occurrence   On 21-Jul-2025 the patient developed breathing difficulty/ as the day progressed/ got worse (dyspnoea) (unknown latency) following the administration of influenza vaccine.   On an unknown date the patient developed has asthma, that was exacerbated by a recent flu shot (asthma) (unknown latency) following the administration of influenza vaccine.  Reportedly, the patient was hospitalized, due to severe breathing difficulty yesterday morning. As the day progressed, he got worse and went to er at 10pm. He was admitted at around 2am, after he was given 3 breathing treatments. He has asthma, that was exacerbated by a recent flu shot. The patient was started on steroid and is breathing better now.   Action taken was not applicable.  Patient received 3 breathing treatments  and steroid for the events.  At the time of reporting, the outcome was Recovering / Resolving for both the events.  Seriousness criteria: The patient was hospitalized for this event (Dyspnoea). from JUL-2025; Sender's Comments: Sanofi company comment dated 25-JUL-2025: This case involves a 77 years old male patient (65.45 kg) who had breathing difficulty/ as the day progressed/ got worse and has asthma, that was exacerbated by a recent flu shot after receiving vaccine influenza vaccine. Further information regarding allergic history and tolerance,  laboratory investigations excluding alternative etiologies, hospitalization details for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. The patient has a history of asthma that might play confounding role in the occurrence of dyspnea. US-SA-2025SA214057:Dupixent case
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Reported Symptoms: 10042674:SWELLING; Narrative: Other Relevant HX: Other: SWELLING
Age: 84.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Rash, Vomiting
Clinical narrative: Reported Symptoms: 10037844:RASH; 10047700: VOMITING; Narrative: Other Relevant HX: Other:
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Reported Symptoms: 10063978: WRONG VACCINE ADMINISTERED; Narrative: Other Relevant HX: Patient got regular rather than high dose vaccine. Other: incorrect vaccine
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Blister
Clinical narrative: Reported Symptoms: 10003658:ATRIAL FIBRILLIATION; 10003662:ATRIAL FLUTTER; 10005216:BLISTERS; Narrative: Other Relevant HX: Other: BLISTER; ATRIAL FIBRILLATION; FLUTTER
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Other Relevant HX: Patient was inadvertently given, in error, a second influenza vaccine instead of TDAP vaccine. PCP was informed. Patient was informed and advised of possible adverse reactions. [Reported from facility] Other: none
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Reported Symptoms: 10025482: MALAISE; Narrative: Other Relevant HX: Other: MALAISE
Age: 68.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Headache, Hyperhidrosis, Myalgia, Vomiting
Clinical narrative: Reported Symptoms: 10016256: FATIGUE; 10019211: HEADACHE; 10028322: MUSCLE PAIN; 10042661: SWEATING; 10047700: VOMITING; Narrative: Other Relevant HX: Other VOMITING; MUSCLE PAIN; FATIGUE; SWEATING; HEADACHE
Age: 33.0
Sex: M
Vaccine: FLUC3
Symptoms: Anaphylactic reaction
Clinical narrative: Reported Symptoms: 10002218: ANAPHYLAXIS; Narrative: This is a historical ADR that was marked as observed. Occurred in (withheld) in 2014. No records or details known. Patient reports anaphylaxis Other Relevant HX: Other: ANAPHYLAXIS
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Reported Symptoms: 10046735: URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Imaging procedure abnormal, Lymphadenopathy, Myalgia
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10016558:FEVER; 10019211:HEADACHE; 10025197:LYMPHADENOPATHY; 10028411:MYALGIA; 10034960:PHOTOPHOBIA; 10040604:SHORTNESS OF BREATH; Narrative: Patient's pain in arm was so severe he presented to emergency room. Imaging of the left arm axillary area revealed 3 lymph nodes. Patient was discharged with recommendation to use cold compresses, tylenol, and ibuprofen. Other Relevant HX: Other: left axillary lymphadenopathy;SHORTNESS OF BREATH; PHOTOPHOBIA
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia, Pyrexia
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10016558:FEVER; 10019211:HEADACHE; 10025197:LYMPHADENOPATHY; 10028411:MYALGIA; 10034960:PHOTOPHOBIA; 10040604:SHORTNESS OF BREATH; Narrative: Patient's pain in arm was so severe he presented to emergency room. Imaging of the left arm axillary area revealed 3 lymph nodes. Patient was discharged with recommendation to use cold compresses, tylenol, and ibuprofen. Other Relevant HX: Other: left axillary lymphadenopathy;SHORTNESS OF BREATH; PHOTOPHOBIA
Age: 83.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Patient got high dose flu vaccine and it was later discovered that the patient had already had the flu vaccine at his doctor office 9.25.23. Other Relevant HX: Other: none
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX: Other: RASH
Sex: M
Vaccine: COVID19
Symptoms: Face oedema, Swelling face
Clinical narrative: Reported Symptoms: 10014222:EDEMA FACE; Narrative: Other Relevant HX: Other: FACIAL SWELLING
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Reported Symptoms: 10037087: PRURITUS; 10037844: RASH; 10046735: URTICARIA; Narrative: Other Relevant HX: Other: URTICARIA
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Reported Symptoms: 10042244:STROKE; Narrative: Other Relevant HX: Other:
Age: 76.0
Sex: M
Vaccine: FLUX
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Reported Symptoms: 10067482: NO ADVERSE EVENT; Narrative: Other Relevant HX: Reported via (withheld) copying here: Patient here given a flu vaccine instead of a Covid vaccine. Patient was also given a RSV vaccine. LPN notified pact provider as well as the nurse manager. LPN called patient, explained the situation, patient was very understanding, will wait till at least two weeks to get his covid vaccine. Other: none
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: Reported Symptoms: 10016797: FLU-LIKE SYMPTOMS; Narrative: Other Relevant HX: this is a historical documentation with visit on 12-5-23. Other: INFLUENZA-LIKE ILLNESS
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pyrexia
Clinical narrative: Reported Symptoms: 10013573:DIZZINESS; 10016558:FEVER; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: FEVER
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Milk allergy
Clinical narrative: Acquired milk allergy
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Acute myocardial infarction, Asthenia, Atrial fibrillation, Cardiac failure congestive
Clinical narrative: 10/31/24 -felt weak/poorly. Abdominal pain, vomiting then constipation. 11/11/24 -ER/Hospital admission for acute and severe edema/dyspnea acute CHF with associated hypokalemia and hypomagnesemia.  11/23/23 ER for racing heart and chest pain and admitted with dx of heart attack (NSTEMI) statin started.  11/26/24 New onset Afib Eliquis started. 12/18/24 ER /Hospital admission for extreme weakness and muscle pain and dx with Rhabdomyolysis
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiomegaly, Chest X-ray abnormal, Chest pain, Constipation, Dyspnoea
Clinical narrative: 10/31/24 -felt weak/poorly. Abdominal pain, vomiting then constipation. 11/11/24 -ER/Hospital admission for acute and severe edema/dyspnea acute CHF with associated hypokalemia and hypomagnesemia.  11/23/23 ER for racing heart and chest pain and admitted with dx of heart attack (NSTEMI) statin started.  11/26/24 New onset Afib Eliquis started. 12/18/24 ER /Hospital admission for extreme weakness and muscle pain and dx with Rhabdomyolysis
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Echocardiogram abnormal, Feeling abnormal, Heart failure with preserved ejection fraction, Hypokalaemia, Hypomagnesaemia
Clinical narrative: 10/31/24 -felt weak/poorly. Abdominal pain, vomiting then constipation. 11/11/24 -ER/Hospital admission for acute and severe edema/dyspnea acute CHF with associated hypokalemia and hypomagnesemia.  11/23/23 ER for racing heart and chest pain and admitted with dx of heart attack (NSTEMI) statin started.  11/26/24 New onset Afib Eliquis started. 12/18/24 ER /Hospital admission for extreme weakness and muscle pain and dx with Rhabdomyolysis
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Oedema, Palpitations, Pulmonary oedema, Rhabdomyolysis
Clinical narrative: 10/31/24 -felt weak/poorly. Abdominal pain, vomiting then constipation. 11/11/24 -ER/Hospital admission for acute and severe edema/dyspnea acute CHF with associated hypokalemia and hypomagnesemia.  11/23/23 ER for racing heart and chest pain and admitted with dx of heart attack (NSTEMI) statin started.  11/26/24 New onset Afib Eliquis started. 12/18/24 ER /Hospital admission for extreme weakness and muscle pain and dx with Rhabdomyolysis
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Right ventricular enlargement, Right ventricular systolic pressure increased, Vomiting
Clinical narrative: 10/31/24 -felt weak/poorly. Abdominal pain, vomiting then constipation. 11/11/24 -ER/Hospital admission for acute and severe edema/dyspnea acute CHF with associated hypokalemia and hypomagnesemia.  11/23/23 ER for racing heart and chest pain and admitted with dx of heart attack (NSTEMI) statin started.  11/26/24 New onset Afib Eliquis started. 12/18/24 ER /Hospital admission for extreme weakness and muscle pain and dx with Rhabdomyolysis
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Migraine, Pain, Vomiting
Clinical narrative: I received my Covid-19 booster shot and that day got a migraine. I've had constant migraines ever since. It's awful and no way to live. I see a neurologist and have tried many interventions but nothing truly works. I have to take migraine medicine constantly and even that doesn't always work. I'm in pain all the time and generally feel awful.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Lacrimation increased, Lethargy, Ocular discomfort
Clinical narrative: Patient reported having chills, body aches and watery eyes around 1:30 AM on 7/31/2025. Patient described the watery eyes felt more like sand in his eyes which required him to wipe often.  Patient took ibuprofen and melatonin. His symptoms subsided around 4:30 AM. However, he reported feeling weak and lethargic.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient did NOT have an adverse reaction.  Patient was given the adult dose of Covid-19 (Comirnaty) by mistake instead of the Pediatric dose of pfizer (5y-11y) that was ordered.
Age: 75.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Pyrexia, Urinary tract infection
Clinical narrative: Pt experienced high fever, dizziness, UTI.  Was hospitalized.  Recovered.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy, Seizure, Syncope
Clinical narrative: Patient is currently pregnant 28 weeks 3 days, EDD 10/20/2025. Patient had 2 previous pregnancies 2019 and 2024. Patient received Tdap vaccine and 5 minutes later became dizzy/lightheaded and when walking down the hall with a staff member began to faint and seized. Patient was lowered to the floor and protected, physician called to come provide aid, patient came out of seizure and he administered a snack and apple juice. Physician ordered to call EMS, upon arrival patient was evaluated and declined EMS transport to labor and delivery at the hospital. Patients' significant other took patient to the hospital instead for further evaluation.
Sex: F
Vaccine: VARZOS
Symptoms: Scleritis
Clinical narrative: Scleritis; This serious case was reported by a physician via sales rep and described the occurrence of scleritis in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included rosuvastatin.   On 20-JUN-2025, the patient received the 1st dose of Shingrix. On 20-JUN-2025, less than a day after receiving Shingrix, the patient experienced scleritis (Verbatim: Scleritis) (serious criteria GSK medically significant and other: Serious as per reporter). In JUL-2025, the outcome of the scleritis was resolved.   The reporter considered the scleritis to be related to Shingrix.     The company considered the scleritis to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2025 The physician reported that the patient received Shingrix and experienced scleritis; Sender's Comments: A case of Scleritis, less than a day after receiving Shingrix, in a 66-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.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administering an early second dose of Twinrix (21 days after the first dose); This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 23-JUL-2025, the patient received the 2nd dose of Twinrix. On 23-JUL-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: administering an early second dose of Twinrix (21 days after the first dose)). The outcome of the drug dose administration interval too short was not applicable.   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: 24-JUL-2025 The reporter wanted to know how to proceed after administering an early second dose of Twinrix (21 days after the first dose) to a patient that was getting vaccinated for immigration matters.  The patient received 2nd dose of Twinrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: he is dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (he is dead) 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 fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. Patient took 5 shots, and he died.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787428:Master case; Reported Cause(s) of Death: he is dead
Vaccine: COVID19
Symptoms: Mental disorder, Myocarditis, Nervous system disorder, Pericarditis, Rash
Clinical narrative: Myocarditis/inflammation of the heart; inflammation of the lining of the outside of the heart; Neurological issues; psychological issues; vision issues; tinnitus; rashes; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis/inflammation of the heart) and PERICARDITIS (inflammation of the lining of the outside of the heart) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis/inflammation of the heart) (seriousness criterion medically significant), PERICARDITIS (inflammation of the lining of the outside of the heart) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (Neurological issues), MENTAL DISORDER (psychological issues), VISUAL IMPAIRMENT (vision issues), TINNITUS (tinnitus) and RASH (rashes). At the time of the report, MYOCARDITIS (Myocarditis/inflammation of the heart), PERICARDITIS (inflammation of the lining of the outside of the heart), NERVOUS SYSTEM DISORDER (Neurological issues), MENTAL DISORDER (psychological issues), VISUAL IMPAIRMENT (vision issues), TINNITUS (tinnitus) and RASH (rashes) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. Patient had myocarditis, which was the inflammation of the heart, inflammation of the lining of the outside of the heart. Also had chest pain, shortness of breath, fluttering, neurological issues, psychological issues, vision issues, rashes and tinnitus. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787428:Master case
Vaccine: COVID19
Symptoms: Tinnitus, Visual impairment
Clinical narrative: Myocarditis/inflammation of the heart; inflammation of the lining of the outside of the heart; Neurological issues; psychological issues; vision issues; tinnitus; rashes; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis/inflammation of the heart) and PERICARDITIS (inflammation of the lining of the outside of the heart) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis/inflammation of the heart) (seriousness criterion medically significant), PERICARDITIS (inflammation of the lining of the outside of the heart) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (Neurological issues), MENTAL DISORDER (psychological issues), VISUAL IMPAIRMENT (vision issues), TINNITUS (tinnitus) and RASH (rashes). At the time of the report, MYOCARDITIS (Myocarditis/inflammation of the heart), PERICARDITIS (inflammation of the lining of the outside of the heart), NERVOUS SYSTEM DISORDER (Neurological issues), MENTAL DISORDER (psychological issues), VISUAL IMPAIRMENT (vision issues), TINNITUS (tinnitus) and RASH (rashes) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. Patient had myocarditis, which was the inflammation of the heart, inflammation of the lining of the outside of the heart. Also had chest pain, shortness of breath, fluttering, neurological issues, psychological issues, vision issues, rashes and tinnitus. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787428:Master case
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: causing tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (causing tinnitus) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (causing tinnitus). At the time of the report, TINNITUS (causing tinnitus) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. Patient probably took the same doses. These shots were causing tinnitus. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 31-Jul-2025, significant correction was performed to remove the classification of Invalid, Updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787428:For doctor
Vaccine: COVID19
Symptoms: Cardiac failure, Lymphatic disorder
Clinical narrative: Heart Failure; lymphatic system failed; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 16Jul2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP.  An elderly 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: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "Heart Failure"; LYMPHATIC DISORDER (non-serious), outcome "unknown", described as "lymphatic system failed".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Asthenia, Coeliac disease
Clinical narrative: I am a Celiac; energy that I usually have daily has disappeared / extremely weak; 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: COELIAC DISEASE (medically significant), outcome "unknown", described as "I am a Celiac"; ASTHENIA (non-serious), outcome "unknown", described as "energy that I usually have daily has disappeared / extremely weak".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: Patient reported two times had COVID. Taken Paxlovid in the past when having COVID responded had it once. Whenever that was, mean that was a couple years ago. Patient was fully vaccinated, and have had Pfizer shots, all of them so, much gratitude. Patient thought had nine vaccine over the last four years.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid as treatment for events.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had COVID two times. Patient received Paxlovid as treatment. Reported that was a couple years ago. Patient was fully vaccinated, and have had Pfizer shots, all of them.   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: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". This is for the first Covid of the patient. The patient reported that she was fully vaccinated and had Pfizer shots.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500152235 same reporter/patient, different vaccine and event;US-PFIZER INC-202500152236 same reporter/patient, different vaccine and event;
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Musculoskeletal stiffness
Clinical narrative: she had limited range of motion with her left arm; can't shave, no ponytails; still feeling sore and stiff; remained swollen; hurt like crazy; Initial information received on 23-Jul-2025 regarding an unsolicited valid  non-serious case received from a patient.  This case involves an unknown age female patient who had limited range of motion with her left arm, can't shave, no ponytails, still feeling sore and stiff, remained swollen and hurt like crazy after receiving  Influenza Quadrivalent Recombinant Vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Nov-2018, the patient received 0.5 ml dose of suspect Influenza Quadrivalent Recombinant Vaccine, unknown formulation, lot QFA1818, expiry date:30-Jun-2019, strength not reported via unknown route in the left deltoid for influenza.  On 03-Nov-2018 the patient hurt like crazy (vaccination site pain) (latency :same day).  On an unknown date the patient had limited range of motion with her left arm (vaccination site movement impairment), can't shave, no ponytails (loss of personal independence in daily activities), still feeling sore and stiff (musculoskeletal stiffness) and remained swollen (vaccination site swelling) (unknown latency).   Reportedly,Patient said that she was not taking any pain meds such as Meloxicam, she used some ointments and ice packs. Through the years, she said that she had physical therapies, MRIs [Magnetic resonance imaging], she had seen multiple nice doctors.On one of her MRIs, she mentioned that she was informed that a little bursitis was seen,her doctor suggested surgery, but he did not guarantee that the swelling would go down.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.