chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states she developed a fever late monday/early tuesday along with nausea. Moderate/Severe redness, swelling and pain started Tuesday morning as well. She states Tuesday her arm was very painful and couldn't move it very well. She states it is improving at this point in time.
Welts on right upper arm 7 days after 2nd dose that was itchy. 7/22 started having pain and swelling on right upper arm and pain lifting up arm
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In July 2013, the patient was inoculated with ZOSTAVAX at a family physician's office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-JUN-2016, the patient was treated by a Physician's Assistant and a medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt recv vax 8AUG97 & 8.5hr p/vax pt exp generalized hives & self-medicated w/DPH;pt went to an ER when face & lips became swollen;pt hosp form 8AUG97 to 12AUG97 & treated w/IV meds pred & antihistamines;
sickest ever been; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 28-Nov-2020.  This case involves a patient of unknown demographic who was sickest ever been (Illness), while the patient received INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious sickest ever been (illness) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Severe arthralgias and myalgias describes as severe as the Chikunguya the patient had on 2014, fever (range from 37.3 to 38), nauseas, headache, chills, tireness that lasted 48 hrs
Side effects - Left arm swelling, very sore to touch, fever, body aches, also reported (L) shoulder & neck pain. Around 6/11/19 - 8:01 pm next day. Scheduled w/ MD for visit still having similar symptoms, pt was advised to take motrin/tylenol for control & ice pack till her appt on 6/12/19. Pt saw Dr., Doctor.'s Overview: on 6/12/19: Taking Tylenol 500 2 tabs & Motrin 400 q6HRS w/worsening pain over time. No H/O PCV in past but gets annual flu shot without event. H/O anaphalaxis to mascara with SOB & angioedema. No SOB, no angioedema, no dysphagia at current time. Doctor's Assessment/Plan @ visit 6/12/19:  - severe local RXN to PCV23, likely not cellulitis or DVT or abscess.  - Ultrasound to eval for DVT or abscess. - Tylenol & Motrin alternating, ice x20 minutes 4x/day.  - Start Zyrtec 10 1 tab daily, & Zantac 150 2xDay until resolved.  - epipen use if develops SOB, cough, or wheeze given history of anaphylactic reaction to mascara.  Relevant Orders: CBC with Diff, CMP, D-Dimer, US. Upper Extremity Arteries Duplex (Bilateral) Final Results: Subcutaneous edema @ the location of vaccination in the left arm. No abscess, no left upper extremity venous thrombosis.  6/14/19: Pt went to urgent care, still having low grade 99.0 fever, swelling & pain. MD final diagnosis states she had cellulits of (L) arm - advised to apply warm compress 3xday for 15 minutes @ a time. Take oral Keflex as prescribed, take probiotic such as Culturelle. Check temp 3 xday. If fever, spreading redness, or worsening symptoms, recheck. Follow up w/PCP.
Pt initially felt palpitations, numbness around mouth and overall unwell. BP was elevated, EMS was called. Pt felt better after 30 minutes and went to an urgent care. Her blood pressure improved and now has follow up with her PCP.
Patient received her polio vaccine on Wednesday August 19, 2009 after 3:30 Pm during her scheduled well exam. On Saturday August 22nd at about 3PM she experienced these symptoms:paleness, sore throat, dizziness & rapid heart beat. When the rapid heart beat did not subside, she waw taken to the ER. There she was diagnosed with tachycardia.
experienced seizure like activity; Initial information received on 10-Oct-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a 16 years old and unknown gender patient who experienced seizure like activity while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Aug, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (formulation: injection, strength: unknown) lot U7249AA, expiration date:11-Mar-2024 in unknown administration site as immunization  On an unknown date  of 2022, the patient experienced seizure like activity (seizure) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE. This event was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced seizure like activity).  At time of reporting, the outcome was Unknown for the event experienced seizure like activity.; Sender's Comments: Sanofi company comment dated on 13-Oct-2022:This case involves a 16 years old and unknown gender patient who experienced seizure like activity while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  Furthermore information regarding medical history, past medical treatment, vaccinations, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
After receiving the first vaccine on 22Oct2021 I started experiencing tingling in my face: lips, gums, tongue; face. This symptom still continues till this day, but is felt all throughout my body now; I had an extreme change in my stool/bowel movements were multi colors, frothy and granulated for several months; My bowel movements were multi colors; Increased tiredness, dizziness, pressure in neck and head; Increased tiredness, dizziness, pressure in neck and head; After receiving the first vaccine on 22Oct2021 I started experiencing tingling in my face: lips, gums, tongue; face. This symptom still continues till this day, but is felt all throughout my body now; Increased tiredness, dizziness, pressure in neck and head; Increased tiredness, dizziness, pressure in neck and head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 12:00 as dose 1, single (Lot number: EW0172) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 22Oct2021 at 16:00, outcome "not recovered", PARAESTHESIA (non-serious) with onset 22Oct2021 at 16:00, outcome "not recovered" and all described as "After receiving the first vaccine on 22Oct2021 I started experiencing tingling in my face: lips, gums, tongue; face. This symptom still continues till this day, but is felt all throughout my body now"; ABNORMAL FAECES (non-serious) with onset 22Oct2021 at 16:00, outcome "unknown", described as "I had an extreme change in my stool/bowel movements were multi colors, frothy and granulated for several months"; FATIGUE (non-serious), DIZZINESS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious), HEAD DISCOMFORT (non-serious) all with onset 22Oct2021 at 16:00, outcome "unknown" and all described as "Increased tiredness, dizziness, pressure in neck and head"; FAECES DISCOLOURED (non-serious) with onset 22Oct2021 at 16:00, outcome "unknown", described as "My bowel movements were multi colors". The events "after receiving the first vaccine on 22oct2021 i started experiencing tingling in my face: lips, gums, tongue; face. this symptom still continues till this day, but is felt all throughout my body now", "i had an extreme change in my stool/bowel movements were multi colors, frothy and granulated for several months", "my bowel movements were multi colors" and "increased tiredness, dizziness, pressure in neck and head" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of paraesthesia oral, paraesthesia, abnormal faeces, faeces discoloured, fatigue, dizziness, musculoskeletal discomfort, head discomfort.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201332981 Same patient/event and different doses;US-PFIZER INC-202201333394 Same patient/event and different doses;
Tuesday AM got her COVID-19 vaccine number 2 +subjective fever, chills, headache that day of. Temp was 99.4 Tuesday Tired and body aches yesterday (Wednesday) Those all have resolved now  Right hand 17 Feb started to feel itchy. Left arm sore. 18 Feb noticed onset of rash on her bilateral ventral forearms (about palm to elbow) that is faintly red, raised, and itchy. No other rash elsewhere at that time She has noted what feels like swollen lymph nodes (lumps) in her left axilla   No other reported symptoms; CP, SOB, GI sxs  No reactions to the first COVID-19 shot
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 4:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 4:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 28.04.  Concomitant products were not provided.  On 28-Apr-2021, excursion time was 9 AM, temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 28-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 40, 12 PM: 41, 1PM: 41, 2 PM: 39, 3 PM: 41 and 4 PM: 40.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
One week later, sudden stomach pain in middle of night. Went to bathroom, syncopal episode X2, passed out, taken to hospital via ambulance. Loop recorder indicated 30-second pause in heart X2, admitted, received pacemaker. No history of syncope.
With the first two, I had similar symptoms that were common to the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.). At the time of the report, VACCINATION COMPLICATION (With the first two, I had similar symptoms that were common to the vaccine.) outcome was unknown. Not Provided    mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medication information was provided.  No treatment medication information was provided.   This case was linked to MOD-2021-341009 (Patient Link).
Irregular periods for a few months after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adolescent female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number: 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "recovered", described as "Irregular periods for a few months after vaccination". Therapeutic measures were not taken as a result of menstruation irregular.   Additional information: If other vaccine in four weeks, covid prior vaccination, covid tested post vaccination; were all unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-AUG-2015 the patient inadvertently received an expired first dose of GARDASIL (dose, strength and route were not reported) lot # H020002 with expiry date: 08-AUG-2015. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
she uses a walker all the time now; She said that her legs were floppy; she lost the use of her legs; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in arm right on 11Feb2021 (at the age of 86-years) as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL0140) at the age of 86-years, dose 1, on 28Dec2020 in right arm for covid-19 immunization. The patient got first vaccine 28Dec2020 and then got the second vaccine on 11Feb2021 on a Thursday, states the next day 12Feb2021, the patient had no use of legs, they were flopping all over. The patient wants to know why this happened, the patient was wondering why did her legs go bopping around, states it improved a couple of days later but the patient uses a walker all the time now. The outcome of had no use of her legs was recovering and outcome of other events was unknown.   No follow up attempts are needed. No further information is expected.
At 1:29PM, shortly after vaccine administered, patient experienced facial swelling and difficulty breathing and epinephrine was administered and 911 was called. Patient experienced increased airway secretions, complained of headache and swelling improved with the epinephrine. Vitals: BP 138/98 mmHg, HR 76 beats per min, PO2 98% At 1:36PM facial swelling increased, lungs diminished, and a second epinephrine injection was administered. At 1:40PM EMS arrived, angioedema improving, secretions improving, and patient transported by EMS to emergency department.
Fever of 101F; headache; tiredness; arm pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), on 17Feb2021 at 11:30 AM (at the age of 26-years-old) at 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine was received in four weeks. The patient experienced fever of 101F, headache, tiredness, arm pain on 18Feb2021 at 12:00 AM. No treatment was received for the events. The patient was recovering from the events.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
screaming episodes (high pitched abnormal crying) <3 hrs; temp 100.3; MD order no more Pertussis;
I have a huge red, swollen mass in my right arm around the shot site.  It is going on Day 4 and it is hot and burns.
Vaccination was given in left thigh.  By the following day I was experiencing a lot of pain in the thigh.  Very painful to walk and was limping badly.  Two days after (Sunday) it was still painful and I could not walk without limping.  The vaccine site was very swollen (and still is slightly swollen nine days later) and was a rather dark, intense shade of red.  I had a headache the following day and fatigue for several days.
Have seen primary care physician which has referred to Neurologist. Appointment with Neurologist is December 15, 2021
A 12 year old patient was vaccinated with Quadracel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (GMI) (Reference number- 00718133) and transmitted to Sanofi on 10-Aug-2020.  This case involves a 12-year-old female patient who was administrated DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] [Product administered to patient of inappropriate age].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot U693588 and expiry date: 26-May-2023) via unknown route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  It was reported, "I gave a Quadracel injection to a 12 year old who didn't need it. Are there any concerns?"  No adverse event was reported.   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 by the regulatory authority. 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
Muscle twitching daily starting day-of or day after shot. Day 1 was left quad and right tricep. Another day was groin and calf. Each day since, and night, various muscles, including gluts, quad, calves, triceps, both thumbs, groin, left eye I have had several incidents where muscle tightened like a Charlie Horse, usually at night but did not get very painful, and possibly restless leg one night but could have just been a lot of twitching in my leg. Now it has been over 2 weeks and it continues. I'm uncertain whether to get round 2.  The twitching doesn't last too long but it does seem to be more frequent and more lasting. My thumbs just keep twitching.  Very concerning.
Patient stated on the consent for that they were 16 years old with a date of birth of 02/17/2005. We were just alerted by the state 7/29 that the pt actual DOB 02/17/2006 and was under 16 at the time of vaccination which was before authorization for pfizer 12-16.
I administered Jynneos vaccine into patient's left deltoid. Patient tolerated vaccine no visible symptoms.
8/26 Got shot in left upper arm @ 5:40 8/27 Started getting slight chills in PM. Those went away after taking Tylenol.  8/28 Noticed a rash developing all over my back. Went to pharmacy to see if a rash is a side effect and ask if it was contagious.  Advised by pharmacist to take Benedryl and monitor. Planning on going to regular doctor if rash is still there on 8/30. or first available appointment.
This spontaneous report was received from a pharmacist student referring to a 64 year old male patient, with no drug reaction or allergies, no concomitant medication, nor medical history. On 30-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous, single dose, for vaccination (dose and anatomical location were not reported), valid lot # M034765, expiration date 26-OCT-2017.  It was reported that the patient developed a one-side headache, with a tingling sensation (paraesthesia), on 01-JAN-2017. The one-side headache was resolved in one hour without requiring medical treatment and tingling sensation (paraesthesia) was reported as recovered on an unspecified date in January 2017. It was reported that the patient sought medical attention (pharmacy) to report the adverse events. The relationship between ZOSTAVAX and one-side headache, with a tingling sensation (paraesthesia) was not reported.  There was no Product Quality Complaint (PQC) involved. Additional information is not expected as there is no consent to contact the reporter.