chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling in the back of throat and nasopharyngeal area; myalgia; chills; fever; malaise; Initial information regarding an unsolicited valid non-serious case was received from a consumer via The Agency (Reference number- 00416318) on 05-Jan-2021.  The case involved a female patient of unknown age who experienced swelling in the back of throat and nasopharyngeal area (pharyngeal swelling), myalgia, chills, fever (pyrexia) and malaise, while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date in 2016, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UI691AA, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious significant reactions of swelling in the back of throat and nasopharyngeal area (pharyngeal swelling), myalgia, chills, fever (pyrexia) and malaise, unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  The patient had not received a flu vaccine since. Now that she had to get a Covid vaccine, the patient wanted to know what agents in the vaccine might possibly had caused the reaction so that she could avoid those things in the Covid vaccine if possible. The doctor only listed the name and she assumed lot number above and told the patient to contact you for more specific information.  Relevant laboratory test was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
Client reports that her right arm began to swell near the injection site, with redness and warmth in the area. Client denies fever. Client states her arm "hurt real bad".
Enlarged lymph node on right clavicle. Swollen biceps right side, red and tender to the touch.
Nausea, muscle ache, chills, arm soreness and head ache.  I would describe my symptoms as serious, not mild or moderate.  I felt that I was extremely ill for the first 45 hours.  I ate very little and I could not bathe.  I stayed in bed, leaving only to go to the restroom.  On the 3rd day, I was much improved and I would characterize my symptoms as moderate.  I was able to get up for short periods and I was also able to bathe.  On the 4th day (today) I believe that I am symptom free with the exception of continued arm soreness at the injection sight.
Fever, bilateral conjunctivitis, rash, fatigue, cervical lymphadenopathy, neck pain. Diagnosed and treated for MIS-C with IVIG x 1, IV Methylprednisolone x 3 days, followed by Prednisolone taper. Normal echocardiograms x 3. Discharged home after 4 days of admission to complete steroid taper. Received 2nd Pfizer COVID vaccine on 1/18/2022.
tingling in arms and legs, pain in arms and legs, swollen legs, high blood pressure, rapid heart rate, nausea, vomiting, burning sensation in upper back, burning sensation in buttocks, thighs and soles of the feet, tingling or hot spots in ankles and wrists,  Symptoms started 2 weeks after vaccine  - May 7th  and I'm still experiencing symptoms on June 9th.    Prednisone, Hydrochlorothiazide  were prescribed.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at a clinic for shingles. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered/not resolved. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
On or about 10 am July 1, 2021, said patient stated that she was 18 years old. That, she, herself, made all medical decisions for herself as an adult. The patient was registered in the normal manner. Patient requested Moderna Vaccination. Moderna was administered in the prescribed dosage and route. On or about August 2, 2021 at noon, the patient was contacted for her second dose of Moderna to complete the vaccine series. Patient was again registered in the normal manner. The series was then completed with administration of second Moderna dose. After further review it was discovered the patient was in fact 17 years and 6 months. The patient has had no adverse reactions.
RT THIGH RASH/HIVES MEASURING 11.5CM X 8CM ONSET WITHIN 24 HRS OF HEP A
Patient fainted and has a small seizure shortly after vaccination. Her patents were present and declined treatment. Mom is a nurse. patient regained consciousness after about 1 minute. Was given water and lollipop (sugar). Stayed about 15 minutes til felt well enough to go home. Pt doing well per follow up call at 4:30pm.
Since vaccination of second dose, I have experienced chronic dizziness and spells of vertigo.  Vertigo: First occurrence was in Feb 2021 after second vaccination. Occurred when getting up for work in the morning (4 am). Nausea, vomiting, dizziness, loss of balance. Vertigo episodes have only happened twice since the first episode. Total of 3.  Dizziness: Daily occurrence that affects when I turn my head quickly up, down, left, or right. Has been an everyday event since my first episode of vertigo.
This spontaneous report was received from a healthcare professional referring to a 13 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 11-DEC-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
feel like i had strong autoimmune response; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (feel like i had strong autoimmune response) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (feel like i had strong autoimmune response) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (feel like i had strong autoimmune response) outcome was unknown.            No concomitant medications details were reported.  Patient received first 3 doses of Moderna to which patient had zero reaction, however patient felt like patient had strong autoimmune response to dose number 3, so patient avoided dose number 4 until updated booster.   On 12-Sep-2022, patient received Pfizer bivalent vaccine booster, 10 months after dose 3.   No treatment medications details were reported.  Company comment. This spontaneous case concerns a patient (unknown age and gender), with no medical history reported, who received three doses of mRNA  1273 vaccine and experienced the unexpected, serious (medically significant) event of autoimmune disorder. The patient received 10 months after third dose of mRNA  1273 vaccine a dose of Pfizer COVID  19 vaccines. Latency cannot be properly assessed since exact onset date and vaccination date was not provided. The report stated that the patient experienced a strong autoimmune response to dose 3. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient (unknown age and gender), with no medical history reported, who received three doses of mRNA  1273 vaccine and experienced the unexpected, serious (medically significant) event of autoimmune disorder. The patient received 10 months after third dose of mRNA  1273 vaccine a dose of Pfizer COVID  19 vaccines. Latency cannot be properly assessed since exact onset date and vaccination date was not provided. The report stated that the patient experienced a strong autoimmune response to dose 3. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient with 3 COVID vaccines who admitted to hospital with complications from COVID and COVID detected PCR.  Provider d/c note:  "85-year-old female presenting to the emergency department with epigastric pain that radiates to her sternum.  This has been going on for 2 days.  She is COVID positive via home test and has been started on Paxlovid.    Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) See below note for details re: this current hospitalization.   Hospital Course: No notes on file  These were her acute medical issues addressed:   Covid infection - 19 infection  tested 9/11/22 - Holding paxlovid - No resp complaints, no hypoxia. - Vaccinated x 3 doses. Last booster dose 12/2021 - 10 days out from her first symptoms at discharge.   A Fib with slow ventricular response, rates in 40-60'ss Hx of HTN  Hx of PVC Diastolic heart failure Prolonged QTc - Echo 4/25/22: EF 70%, trace AR, mild - mod TR, RVSP 42mmHg - Held home Norvasc, chlorthalidone, Toprol, Valsartan given bradycardia and low normal BP on admission. - resume Norvasc, ARB at discharge. - continue to hold Chlorthalidone at DC. DC Toprol due to bradycardia. - Consult cardiology: Seen by Dr and Dr. She has declined PPM placement at this time. - on Pradaxa for chronic AF.   Anorexia, nausea, resolved  - General diet - Zofran prn, consider compazine if QTc prolonged. - may have contributed to hyponatremia.   Hyponatremia  - Sodium 108 on admission, corrected with IVF and salt tablets  - Poor PO intake (COVID) +/- chlorthalidone use likely the main mechanism. Also may have had a component of SIADH, given nausea the preceding days. - no encephalopathy. Mentation maintained. -- IV NS + NaCl tabs. -- Na 129 at discharge.   Hypomagnesemia  Hypokalemic Hypophosphatemia - replace as needed    DC home today with Home Health RN Will hold BB and Chlorthalidone at discharge."
EDD - 4/1/2021 - Contractions at 26 w 3 days sent to L&D to be monitored on 12/28/20. Covid-19 Sars Vaccine given 1st dose 12/27/20. Patient was diagnosed with Fetal Hydrops. Patient Hospitalized 12/28/20 - current MFM consulting in hospital & outpatient
This is a spontaneous report received from contactable other HCP/consumer or other non-HCP, for a Pfizer sponsored program (051529). A 29-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed malaise/sickness (outcome unknown). Additional information: Patient missed a couple weeks of doses due to getting the COVID-19 shot and being sick. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report: US-PFIZER INC-202101224414 (same patient and reporter, different product and events).
MENSTRUAL CYCLE DYSREGULATED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced menstrual cycle dysregulated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of menstrual cycle dysregulated was not reported. This report was non-serious. This case, from the same reporter is linked.
Can't lift her arm up all the way; Dizziness; Sore arm; Rash at injection site; Rash on stomach and back; Nausea; Headache non stop; Fever highest 100.8 degree celsius; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site) and RASH (Rash on stomach and back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site), RASH (Rash on stomach and back), NAUSEA (Nausea), HEADACHE (Headache non stop) and PYREXIA (Fever highest 100.8 degree celsius). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (Can't lift her arm up all the way), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Sore arm), INJECTION SITE RASH (Rash at injection site), RASH (Rash on stomach and back), NAUSEA (Nausea), HEADACHE (Headache non stop) and PYREXIA (Fever highest 100.8 degree celsius) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 degree Celsius.         This case was linked to MOD-2021-072760 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Initial follow up added
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of M-M-R II; (lot # L007578 with an expiration date on 05-MAR-2017; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Exposed to COVID-19 after receiving vaccination; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 08Jul2021 as dose 1, single for covid-19 immunisation. Medical history included COVID-19 (prior to receiving his COVID-19 Vaccine) from Dec2020 to an unknown date. The patient's concomitant medications were not reported.  On Jul2021. patient was exposed to COVID-19 after receiving vaccination, as his wife was tested positive for COVID-19 on 14Jul2021 and his son was tested positive on 15Jul2021 after receiving the dose 1 of vaccination. Patient is due for second shot this Thursday 29Jul2021. The outcome of the event was unknown.  Information about the Lot/batch number has been requested.
pt recv vax & w/in hr, pt devel inconsolable crying which cont all day;this of 1 of 3 pt who devel inconsolable crying p/vax;
Terrible arm muscle pain, limited movement, weakness in arm.  Unable to lift arm beyond shoulder.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a six-months old male patient who was vaccinated with a 0.5 ml dose of PENTACEL (lot C5466AB, expiry date: 05-Sep-2019, via intramuscular route in the right thigh) and 0.5 ml dose of ACT-HIB (lot UI902AA) via intramuscular route in the left thigh on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. The patient received a double dose of ACT HIB by having both the vaccines. It was reported that the patient did not experience any adverse event following the vaccination. 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 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Client received all three vaccines.  Afterwards she stated she was feeling faint.  This RN called out for other nurses for help.  Patient passed out and tried to revive her with ammonia cap.  No response to ammonia.  Patient stiffened up and had grand mal seizure about 30-45 seconds.  911 was called.  Patient came around and was transferred by ambulance to ER.
My son (2 years, 8 months) received the Pfizer COVID 19 injection in his left arm on Friday morning at 9am. His behavior was normal after the injection, he did not complain of any pain and was playing and running as normal. He went to bed at 730 without any issues and still no side effects from the injection. On Saturday 6/25/2022 at around 6:45 he woke up screaming because he could not move his head. If he moved, he would scream in agony. His head maintained a position to the right without inducing pain. Motrin and Tylenol were given with no impact. Urgent Care was called and instructed to give Benedryl 5mg and wait 1 hour to see if symptoms improved. At 45 minutes after the benedryl was given, he was still screaming at any movement. He remained laying with his head to the right without any issue but otherwise could not move his neck. Other extremities were fine, no rashes. He was not warm to the touch but temperature was not taken. Since he was still in pain and unable to move, he was taken to the Emergency Room in. They completed additional tests, including temperature to which no fever was recorded. X-rays which showed no injury. However no improvement was being made. He was given additional Ibuprofen. Heating pads were put on his upper neck. Slow movements were made by family and nurses and after 5 hours he was able to sit upright leaning back on the bed. He eventually was able to then stand and walk around. Instructions were to continue Motrin at regular dosing times 24/7 at home. The following day, Sunday 6/26/2022, there are no signs of any pain. He is not complaining of any pain and is active and back to normal self.
Pain and itching in right arm pit and right collar bone/neck. Alternating Tylenol and advil. Rcvd shot Friday afternoon. Arm pit pain started Saturday and collarbone/neck pain started Sunday.
Delayed period for over 10 days. Have been having tender breasts and PMS symptoms for almost 4 weeks now.  My body works like a clock, every 27-28 days i have a period.    I am not on birth control pills, not on any kind of medications, not pregnant. No health problems.
Initial report was received from a healthcare professional on 24 January 2012. The patients (age and gender not reported) had received an injection of FLUZONE INTRADERMAL; lot number UT4163AA (route, site and date of administration not reported). On an unspecified date, the patients had reactions similar to the reactions described in our literature. No further information was available at the time of this report. The patient's outcome was not reported. Documents held by sender: None.
DULL CONTINUOUS SORENESS AT THE SITE OF THE INJECTION; This spontaneous report received from a patient via a company representative concerned a 42 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced dull continuous soreness at the site of the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dull continuous soreness at the site of the injection. This report was non-serious.
Rec'd Anthrax on 9 Jan. - 9 Jan no problem. Morning on 10 Jan noticed pain/swelling. Came in on 11 Jan morning to have it examined.
This spontaneous report as received from a pharmacist refers to a 28 year old female patient. On 29-JAN-2013 the patient was vaccinated with a dose of live ZOSTAVAX (lot number unspecified). No other suspect therapy reported. No concomitant therapy reported. On an unspecified date the patient had a half dollar sized itchy and blotchy raised area at injection site. It also caused the patient to have nausea. No treatment was given to the adverse events. At the time of the report, the patient was not recovered from the events. The patient had called pharmacist for medical attention. The relatedness for the events to live ZOSTAVAX was unknown. Additional information has been requested.
Hospitalized twice 4/18-4/21 and 4/24-28: Flu-like systems for 6 weeks. Nausea, headache, dizziness, muscle ache, inflammatory markers CRP 23.6, ESR 97, Chest pain, shortness of breath, pericardial effusion, pleural effusion, A-Fib. Manually drained right pleural cavity 400 cc. Fluid came back. Was put on prednisone for 10 days. Fluid was reduced.