chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered with two FLUZONE HD QIV at the same time with no reported adverse event; Initial information received on 31-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 78 years old male patient who was administered with two Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High Dose Quadrivalent] at the same time with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2023, the patient received two times a 0.5 dose of suspect Influenza Quadrival A-B High Dose HV Vaccine (lot UT8057AA, Expiry date: 30-Jun-2024 with unknown strength) via intramuscular route in the left arm and right arm as Immunization with no reported adverse event (extra dose administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I am very sick now; Fever; Cough; lot of pain in the body; Sore throat; Could breathe good, it was like (voice not clear) in my chest (not clear); This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration on 24Apr2021 as SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Apr2021, the patient was very sick now, fever, cough, lot of pain in the body and sore throat. The patient reported could breathe, could breathe good, it was like (voice not clear) in the chest (not clear). The patient wanted to know whether it was okay to take like cold medicine or something like that because the patient took Tylenol and wanted to know whether could take Alka-Seltzer. The patient's second dose was due on 13May2021. The patient underwent lab tests and procedures which included body temperature on 24Apr2021. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Arm pain; Soreness at injection site; Swollen gland in arm pit; Nausea; Headache; Fatigue; General feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 34-Years-Old non-pregnant female patient received second of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER2613) via an unspecified route and on right arm on 19Mar2021 ( at 34 years of age )at 09:30 AM as a single dose for COVID-19 immunisation. The patients medical history included allergies to sulfa drugs. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6201) via an unspecified route and on right arm on 26Feb2021, at 09:00 AM as a single dose for COVID-19 immunisation. The patients did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 20Mar2021, at 08:00 AM, the patient experienced soreness at injection site (vaccination site pain), swollen gland in arm pit, incredibly uncomfortable (swollen lymph nodes) nausea, pain in the arm, headache, fatigue and general feeling unwell (feeling unwell). The patient did not receive any treatment for events. The clinical outcome of vaccination site pain, swollen lymph nodes, pain in the arm, nausea, headache, fatigue and feeling unwell was recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 01-NOV-2017 the patient was vaccinated with an expired dose of M-M-R II (unknown albumin status) lot # L041457 with an expiration date 22-OCT-2017, 0.5 ml, subcutaneously for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT). No adverse effects were reported.
local reaction measuring about 8x3cm, of redness & induration w/pain & itching, lasting 2 days; significant parental concern because pts older sibling also had a more severe local reaction probably to diptheria;
Joint pain; FLU-LIKE SYMPTOMS WITH THE SECOND VACCINE; Achy; Cold; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (Joint pain), INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS WITH THE SECOND VACCINE), PAIN (Achy) and NASOPHARYNGITIS (Cold) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (Joint pain), INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS WITH THE SECOND VACCINE), PAIN (Achy) and NASOPHARYNGITIS (Cold). At the time of the report, ARTHRALGIA (Joint pain) had resolved and INFLUENZA LIKE ILLNESS (FLU-LIKE SYMPTOMS WITH THE SECOND VACCINE), PAIN (Achy) and NASOPHARYNGITIS (Cold) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment medications was not given.  Patient was off of Rinvoq for two weeks due to COVID vaccine and had joint pain that she did not had before stopping.
BRIEF OVERVIEW:  Bilateral PE  Discharge Provider: MD Primary Care Provider at Discharge: NP Admission Date: 4/26/2021 Discharge Date: 4/26/2021    Active Hospital Problems (Diagnosis Date Noted) ? Pulmonary embolism without acute cor pulmonale, unspecified chronicity, unspecified pulmonary embolism type (HCC) 04/26/2021   Resolved Hospital Problems No resolved problems to display.   CONSULTS: None    INPATIENT PROCEDURES: None    DETAILS OF HOSPITAL STAY: Patient is a 51 y.o. male with a past medical history of psoriasis, environmental allergies who presents today with sudden shortness of breath, left side pleuritic chest pain 7/10, worsened with deep inspiration.  No recent travel, no family history, no history of malignancies, no immobilization or surgeries. He had his 2nd dose of Pfizer COVID vaccine on April 1.  He does not have a history of COVID-19 infection, and COVID-19 PCR test was negative in ER. His blood pressure is a little high at 170 6/83 mm, pulse 76 per minute saturating 96% on room air, troponin less than 6, BNP 16, WBC 12.3,, EKG without any significant ST T-wave changes. CT angiogram of the chest shows nonocclusive thrombi in almost all the lobes, there is no saddle embolus noted.  There is no evidence of right heart strain.  Echo: The technical quality of the exam was limited due to suboptimal acoustic windows. The left ventricle is normal in size. There is normal left ventricular wall thickness. The left ventricular ejection fraction is 60%. Regional wall motion abnormalities cannot be excluded due to limited visualization. The right ventricular size, thickness, and function are normal. No significant valvular pathology identified with Doppler examination. There was insufficient tricuspid regurgitation envelope detected to calculate right ventricular systolic pressure.  Injection of contrast documented no interatrial shunt. There is no comparison study available.  He was started on Heparin gtt. And admitted for observation. He required no supplemental oxygen. He was discharged later pm on Eliquis 10 mg bid for 7 days, than 5 mg bid for 3 months. I am questioning did he had COVID-19 vaccine related bilateral PE. His hypercoagulable profile is pending. He has no sign of malignancy, no new symptoms, no weight loss. He had normal colonoscopy 2 yrs ago.  He should follow up with his PCP.  He was given work excuse from 4/26-5/3/21. She shouldn't take non steroidal anti-inflammatory (Ibuprofen (Motrin), Naproxen, Naprosyn, Voltaren, Relafen ... meds because of blood thinner Eliquis. He can take Tylenol 500 mg 1-2 tabs 3-4x a day as needed. He was also prescribed Lidoderm patch.    For HTN he was started on DASH diet and Norvasc 5 mg daily. He should follow up with PCP next week.  Also he was instructed to quit smoking.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: MODERNA COVID-19 VACCINE taken for covid-19 immunisation, on 04Feb2021 as dose 1, single, on 04Mar2021 as dose 2, single, on 22Sep2021 as dose 3 (booster), single. Past drug history included: Methyl prednisone for Allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical Information: It was reported that The patient was not taking any other medications products within 2 weeks of starting COVID-19 treatment and patient previously receive a COVID-19 Vaccine. Days 2-8 very mild symptoms and faint COVID line on rapid test. if patient recovered: Not recovered. No treatment ae reported. known allergies: Penicillin, methyl prednisone, sulfa drugs Device Date :02May2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
NO ADVERSE EVENT REPORTED- BUT PATIENT RECIEVED A HIGH DOSE VACCINE AND IS ONLY 62
Blood clots - DVT; This is a spontaneous report from a contactable consumer (patient) reported that a 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0171), via an unspecified route of administration, administered in arm left on 07May2021 08:15 (at the age of 34-years-old) as 2nd dose, single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included covid-19 prior vaccination. The patient had no known allergies. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP8737), via an unspecified route of administration, administered in arm left on 16Apr2021 08:00 AM (at the age of 34-years-old) as 1st dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levonorgestrel (PILL 72) taken for birth control, start and stop date were not reported. On 12May2021, the patient experienced blood clots - DVT. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of blood clots - DVT as patient received blood thinners. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Dad reports tics 12 hours after flu vaccine, progressed in frequency and severity went to ER on 11.20.15 admit and d/c same day, saw neurologist.
Fever (only 100.4), and terrible body aches over entire body for 4 days. Also fatigue for 4 days. I could not move 1 inch without terrible pain. But pain, significant, remains This date (11-3-20) at left upper arm and shoulder, site of shot and large area surrounding (3 weeks + 5 days later)
Patient felt lightheaded & dizzy 10 minutes after receiving vaccine. Layed down flat with feet elevated for 10-15 minutes.
I experience respiratory issues, coughing, running nose, sinus pressure, coughing up film. I treated with Mucinex, cough syrup, throat spray. Pretty much over the counter medications. And a migraine that caused me to throw up. Getting more frequent headaches. And also feeling fatigue.
3 hours after vaccination developed feverish, fatigue, headache and bone ache. Today persist with same symptoms
lightheadedness/Dizziness; chest pain; disorientation; tachycardia; blood pressure swings; generalized pain; I have had POTS like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 08:30 (Lot number: EP7533) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sleep apnoea syndrome" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 26Apr2021, outcome "not recovered", described as "lightheadedness/Dizziness"; CHEST PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "chest pain"; DISORIENTATION (non-serious) with onset 26Apr2021, outcome "not recovered", described as "disorientation"; TACHYCARDIA (non-serious) with onset 26Apr2021, outcome "not recovered", described as "tachycardia"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 26Apr2021, outcome "not recovered", described as "blood pressure swings"; PAIN (non-serious) with onset 26Apr2021, outcome "not recovered", described as "generalized pain"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) with onset 26Apr2021, outcome "not recovered", described as "I have had POTS like symptoms".The events "lightheadedness/dizziness", "chest pain", "disorientation", "tachycardia", "blood pressure swings", "generalized pain" and "i have had pots like symptoms" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, chest pain, disorientation, tachycardia, blood pressure abnormal, pain, postural orthostatic tachycardia syndrome.  Additional information: The reporter stated that dose 2, information included, Product:COVID 19,Brand: Pfizer,Lot number: EW 0179,Lot unknown: False, Administration date:10May2021,Administration time: 08:00 AM,Dose number: 2,Vaccine location: Left arm.For the past 14 weeks following my vaccination I have had POTS like symptoms. Dizziness, lightheadedness, chest pain, disorientation, tachycardia, blood pressure swings, generalized pain, and more. No history of these issues prior to the vaccine.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient did not receive any other medications within 2 weeks of vaccination.Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination,the patient has been tested for COVID-19.  Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Experience skin nerve pain all over my body; Experience skin nerve pain all over my body; Extreme cold sensation after bowel movements; This is spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided), via an unspecified route of administration on 04Jan2021 10:15 at single dose for covid-19 immunization. Patient is not pregnant. Medical history included severe post concussion syndrome (5 major concussions), anxiety, depression, raynaud's syndrome, pineal gland cyst (last MRI Oct2020 reveal cyst was 12mm). The known allergies included Cipro, sensitive to many food, high allergy to mold, grasses, trees. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fluoxetine hydrochloride (PROZAC), rizatriptan benzoate (MAXALT), montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL) , lactulose (LACTUL), ongoing medications included mometasone furoate (FLONASE), budesonide (BUDESONIDE), olopatadine (OLOPATADINE), ipratropium (IPRATROPIUM) , fremanezumab (AJOVY), allergy shots. 48 hours after injection on 06Jan2021 13:00, patient began to experience skin nerve pain all over body accompanied with extreme cold sensation after bowel movements, has been 6 days and getting worse. She will be going to urgent care tomorrow. She was between primary care physicians until 13Jan2021. Patient didn't receive treatment for the adverse events. The outcome of events was not recovered.   Information about lot/batch number has been requested.
Muscle pain,, shivering, headache, diarrhea, vomiting.
105.6 fever about 16 hours after vaccination; nausea; extreme headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28May2022 at 10:00 as dose number unknown (booster), single (Lot number: FP4554) at the age of 12 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 29May2022 at 02:30, outcome "recovered" (May2022), described as "105.6 fever about 16 hours after vaccination"; HEADACHE (non-serious) with onset 29May2022 at 02:30, outcome "recovered" (May2022), described as "extreme headache"; NAUSEA (non-serious) with onset 29May2022 at 02:30, outcome "recovered" (May2022). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, nausea, headache.  Clinical information: Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not received any other medications the patient received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no.
severe headache/headaches came back/headache will come back later in the day/severe headaches twice a day,and they are pounding; was warm like she had a fever; night sweats; chills; body aches; debilitating; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Feb2021 as 2nd dose, single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. Investigation Assessment was not Provided. On an unspecified date, Patient stated that she had some severe side effects from the COVID-19 vaccine. She got the first dose of the vaccine on 26Jan2021 and had no problems. Patient had the second dose of the vaccine on 17Feb2021 and had no problems. She stated that on the following Sunday, which she believed was 21Feb2021, she had a severe headache, she was warm like she had a fever, night sweats, chills and body aches, and that was how she woke up and she said that she took 2 Advil and ate some food and got better, and she was better throughout that day. But she added that headaches came back during nighttime, but the other stuff subsided some. As she stated, In a couple of days, everything except her headaches was gone. Patient stated that this morning, at 2AM, her headache woke her up, so caller got up and ate, and drank water and she has been drinking at least four 16.9 oz. water bottles a day. She had only one glass of ice tea a day, one cup of coffee, but she was not taken any soda. Since about last Wednesday, all the other stuff went away, and now she is just having the severe headaches twice a day, and they are pounding and debilitating. She wanted to know what to do about the headaches because it will be back. Caller had been taking 2 Aleve or 2 Advil, they both work, but Tylenol doesn't. She knew she was not dehydrated, and she was conscious of her health and she does not want to ruin her kidneys by taking Aleve or Advil everyday. The outcome of event was unknown for severe headache/came back/headache will come back later in the day/severe headaches twice a day, and they are pounding  and debilitating and for rest of the events was recovered.  Description of Product Complaint: Description of complaint: While calling with a question about the suspect product, caller indicated that she has been having severe headaches and two advil or two aleve work to help the pain from the headaches, but Tylenol does not work.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient went into a crowd or ER (for something else) got COVID-19 after. It was never super bad. Patient had covid-19 symptoms as a bad cold and fatigue. Patient thought that patient had delta and omicron strains. Patient assumed the effect of the vaccine was waning after 6 months. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738922 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738922:monovalent case
SWELLING FACE; THROAT SWELLING AND CONSTRICTION. HIVES speech effected slurred since injection, prescribed BENADRYL and prednisone.
PATIENT REPORTED FLU LIKE SYMPTOMS AND BODY ACHES FOR A DAY AND A HALF FOLLOWING THE VACCINATION. BAD ENOUGH THAT SHE HAD TO STAY IN BED AND DIDN'T GO ANYWHERE/DO ANYTHING FOR THAT DAY AND A HALF. WITH HER FIRST SHINGRIX DOSE, THE PATIENT STATES THAT SHE DID NOT HAVE THESE SYMPTOMS.
Woke up next day with headache and chills all day. Developed fever of 100.8F while on Tylenol.   Symptoms gone after 24 hours.