chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA280687 same reporter for 14 years old. This case involves a 10 years old patient (gender unknown) (weight 56.6 kg) received vaccine FLUBLOK QIV. The patients past medical history, concomitant medication and family history were not provided.  On 23-Sep-1018, the patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that Intern gave a 10-year-old FLUBLOCK QIV. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 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. List of documents held by sender- none.
i have very bad trimmers in my hands and face as time has gone on the trimmers are getting worse
Severe headache for two days (and still have mild headache), aching teeth (mainly ones with crowns or fillings), ongoing itching, aching and hard lump at injection site,  weakness and achiness in hands - resolved, extreme sinus drainage causing laryngitis, light sensitivity
Pain at injection site, lethargy, nausea, low grade fever, chills, vomiting, headache, body/joint aches, lightheadedness
No Adverse Events reported - VAERS filed as patient was underage (age 17) at time of vaccination.  Per CDC guidelines, can continue with COVID MODERNA series as off label, with local provider approval.
Date of last menstrual period: 01/31/03. Currently with a pregnancy of 10 weeks, 2 days by ultrasound on 04/24/03. Possible fetal exposure.
no adverse event; patient received an expired dose of PROQUAD; This spontaneous report as received from a registered nurse refers to a 5 year old patient. On 23-MAR-2022, the patient was vaccinated with a 0.5 mL expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T032146 exp date 30-MAR-2022).
Developed body aches, tiredness, fever, and headache.  But the headache never went away, it?s more of a migraine.  The headache and throbbing lessens but there is still some underlying pressure in my head and then it hurts again accompanied by nausea, and I haven?t suffered from migraines.  The migraines seem to be lessening now.   Also, I had just finished my period the week I got the shot and it restarted my period when I got the symptoms.
Got the vaccine at curb side at a pharmacy. was ask to sit and wait incase of reaction in the vehicle I started feeling hot and Tingley like I need to go to the bathroom  so I went inside and told the pharmacist so they sat me down and took my blood pressure and heart rate 168/108  HR 108  then they gave me some Benadryl  and waited about 8 min. to retake my BP again and it about the  same. They called my primary care provider and he said to go to the ER. Did not have problems with  breathing and swalloning. The feeling was like a contracts for a dye to a CT warm and tingles.  Pharmacy called for EMS and was transported. Hospital watched my BP and HR, gave me pepcide, and steroids.  Arrived about 12:15 pm and left 3:30pm. 122/78 HR 73 (approx) now I am home just kinda tired.
24 hrs after immunization parent brought child back with swelling of both legs, right more than left, mild superficial edema of whole thigh.
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 2012, the patient was inoculated with ZOSTAVAX at physician office as recommended for routine adult health maintenance 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 shingles, or severe herpes zoster. In 2013, the patient was treated in a clinic for the onset of rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt recv vax 4MAR96 mom states swelled from shoulder to elbow by that same noc;mom & pt presented to hlth dept later wednesday afternoon;swollen 2+ from other arm sent to pt;MD stated abscess to vax
This spontaneous report was received from a registered refers to a unknown number of patients of unknown age. Since possibly 17-AUG-2011, the patients may have been vaccinated with a dose of improperly stored VAQTA, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse events were reported. This is one of the two reports received from the same reporter. Additional information is not expected.
The COVID-19 vaccine administered through vaccine administrator, , between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.  i
Pt brought in for Altered Mental Status and witnessed seizure. Pt was seen within past month for UTI and pneumonia. CT performed paatchy right greater than left lower lobe opacities are concerning for pneumonia. PEG to be placed on 9/14/21 COVID test performed prior to procedure, resulted positive, and PEG consequently delayed.
2nd shot - 05/18/2007; feet and hands hurt. ached all over - joints legs hurt. Saw doctor 7/20/07.  03/10/2008 MR received from PCP which include rheumatology consults.    Rheumatoid arthristis does not go away. Pt is under the care of a rheumatologist and has started EMBREL injections for her RA.  Pt reported onset of joint pain in June 2007 following Gardasil vax in March 20 and and May 18, 2007(Lot #0245U). Pain initially noted in wrist and fingers with mild swelling noted on exam 7/20/2007.  Fatigue and stiffness increasing by 8/22/07 OV. Rheumatology consult 9/18/07 with confirmed DX of Rheumatoid Arthritis 10/16/07 s/p lab results. 1/20/2010 I was diagnosed iwth rheumatoid arthritis and have chronic joint pain.
Patient was administered the vaccine at 9:50 am At 12:00 pm CPR was requested for the patient who was percieved to be having a heart attack and was unresponsive Was notified by 1:30 pm that the patient had passed away at the hospital
Body ache; Lethargy; Heartburn; Difficulty eating due to nausea and heartburn; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 at 10:45 hours (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Apr2021 at 12:00, the patient experienced headache, body ache, lethargy, nausea, heartburn and difficulty eating due to nausea and heartburn. Starting 4 days after vaccination lasting 5 days. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event headache, body ache, lethargy, nausea, heartburn and difficulty eating due to nausea and heartburn was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received Td 0.5cc IM right deltoid on 4/17/2003, states on 4/19/2003 noted redness right deltoid, today 4/20/03 redness deltoid to just below elbow. Pain, edema noted.
Narrative: Headaches, Fever, body aches, pain in both legs, chills.
Information has been received from a registered nurse regarding a 6 year old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of PROQUAD subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The PROQUAD was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter.; Sender's Comments:  US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253:
Swelling of lymph node above collar bone in the same arm vaccination was received (left side). Aching of left arm.
Early symptoms of onset of Bell's Palsy were experienced on 12/5/2010, including numbness of left side of tongue, eye watering on left side, and ear pain on left side.  Obtained diagnosis at PCP on 12/6/2010.  At that time, partial facial paralysis on left side was what prompted me to seek care.  Treatment included 60mg Prednisone qd for one week.  Eye care as needed.  I continue to have symptoms of Bell's Palsy including lack of taste on left side of tongue, inability to close left eye fully, paralysis of parts of left side of face, pain in left side of face, twitching in left side of face, etc.
1-1 1/2hr p/vax pt devel puffiness around eyes & a rash all over;
1447 Patient given Covid vaccine  1457 Patient developed hives on face and forehead and facial flushing . No facial swelling, trouble swallowing and/or trouble breathing noted. B/P: 98/60 Pulse oximetry: 100% Pulse: 92 Lungs clear 15:30: Facial flushing and hives improving, no facial swelling/trouble breathing/trouble swallowing, patient playing and active in room 15:40 5ml of Benadryl given 15:45 Left office
Constipation, on day 7--could be a coincidence but i don't get constipated and it started the day after the shot
Vaccine admin on Mon 6pm 11/4/13. On Tues -> very lethargic, shivering, 100+ degree temp. On Wed still same. Missed 2 days of work.
THE patient was administered improperly stored VARIVAX; This spontaneous report was received from a registered nurse and refers to a 2-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # T002848, expiration date 23-JAN-2022, site and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine underwent a temperature excursion of -14 degrees Celsius (C) to 10 degrees C (-12.1 degrees C) for 3 hours and -9 degrees C to 8 degrees C (-7.5 degrees C) for 8 hours 30 minutes (multiple excursion). There was no previous temperature excursion. Data logger was involved.
administered vaxelis and ipol at the same day with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 2 months old patient of an unknown gender who was administered VAXELIS and IPV (VERO) [IPOL] at the same day with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (strength, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination. On the same date the patient was also administered with an unknown dose of suspect Vaxelis not produced by Sanofi Pasteur (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site as prophylactic vaccination (immunization), with no reported adverse event (product administration error) (latency: same day). Information on the batch number was requested.  No lab data 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 in the Directive and Regulatory Authority 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.; Sender's Comments:  US-SA-2023SA341553:
Patient felt dizzines and started sweating. He drank some water and after about 15-20 minutes he was feeling better.
Patient presented to our Emergency Department via EMS in full code status; asystole.  Patient expired. Per nursing, husband stated patient awoke this AM and reported pain in back between shoulders and in bilateral shoulders. Patient then went unresponsive and husband called EMS.
Patient fainted while sitting in chair. Started sweating profusely, felt clammy and cold. Elevated legs, checked pulse and pulse oximeter. Was awake and talking within a couple minutes. Gave him cold water and crackers and he was feeling much better. Paramedics arrived and confirmed all was good.
Vaccinated with Pfizer on 2/22/21 and 3/15/21.  Symptom onset on 6/28/21 - cough, muscle ache, nausea, loss of smell, sore throat, headache, fatigue.  Tested positive for Covid-19 on 7/9/21
Approximately two weeks after receiving my first dose, I noticed really bad join pain that lasted for a few days. I was experiencing hot and cold flashes for several months, and incredibly bad brain fog for about 2 months, which affected my short term memory. I would have occasional symptoms of dizziness, lightheadedness, I would sometimes feel palpitations and had trouble sleeping at night but was incredibly exhausted.  After receiving my booster shot, I began experiencing symptoms two weeks after. I had severe joint pain, chills, brain fog, my body felt as if it was buzzing, and cold feet. This lasted for a few days, however, I continued to be exhausted and experience brain fog.
pt recvd vax; had been running T since 12feb96;motrin and apap given; pt was fretful, not sleeping; will take to ped;
Sore arm, fatigue, chest pain, shortness of breath, took Tylenol.
Patient presented to clinic on 2/22/08 with history of fever 24-48 hours.  Lesions x 1 diameter.  Upon exam patient had 98 vesicles scattered over body but primarily on the torso.  Aveeno baths, calamine lotion, Tylenol and isolation was recommended.  2/27/08 P/C to mom "doing better."
fever up to 102.8, cough, tired, sore throat, chills, sweats that soak sheets, puffy face, phlegm stuck in throat
pt began screaming 24hr p/vax mom called MD who said not to give the pt pertussis again;no fever noted;no other rxn noted;
PATIENT IS STILL  HAVING MINOR MUSCLE PAIN IN AREA OF VACCINATION ALONG WITH SLIGHT DISCOLORATION AROUND THE AREA.
The patient is a healthy 25 yo male who developed urticaria after IIV receipt #5 24 NOV 20 (SEQ P100255599). He denies any immediate symptoms after receipt to include pruritis, urticaria, oral/face/throat tongue swelling, CP, SOB, wheeze, cough, n/c/d. He reports vaccine receipt was between 15-16:00 and between 21:00-22:00 (5-7 hours) he suddenly developed pruritis, and raised erythematous urticarial lesions to his stomach, flank, back, knees, and shoulders. The lesions were much improved by morning with only erythematous macules at the original lesion sites. They were fully resolved by midday, estimated no more than 16 hours after onset. He did not treat with anything. He denies oral/face/throat tongue swelling, CP, SOB, wheeze, cough, n/c/d. He denies any other new exposures.  He denies any previous vaccine intolerances or AE.
States she took every single vaccination of all Pfizer/she thinks she had 3-4, she doesn't know/she just finished Paxlovid this morning; States she took every single vaccination of all Pfizer/she thinks she had 3-4, she doesn't know/she just finished Paxlovid this morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "States she took every single vaccination of all Pfizer/she thinks she had 3-4, she doesn't know/she just finished Paxlovid this morning". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated that she took every single vaccination of all Pfizer and had no idea this was going to happen to her. She did not know the names of the vaccines. She took those and the flu shot, it was a shock to her. Pfizer kept coming out with another and another, she thinks she had 3-4, she didn't know. She made sure they were all Pfizer, all the same other than Moderna. She stated that apparently, the variant out there was resistant to the vaccines. She took all the shots for nothing. There was something out that that skirts around vaccines. She asks what was the point. It scared the hell out of her that after all that she was still not covered. She was a little surprised. She doesn't go anywhere, had no idea where she got this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10/29/12 I spoke with Mom, broke out in hives evening of 10/26. Had rec'd MMR #2, VARIVAX #2 and Flu earlier in the day. No resp. s/sx.
He had just been recovering from his second bout of COVID requiring hospitalization in October 2022.  (First COVID + was January 2022 following Moderna booster shot in August 2021, with initial moderna series Jan/Feb 2021.)  At his outpatient follow up after discharge from COVID hospitalization, someone decided to give him the moderna bivalent booster.  A week later, he was readmitted with SOB and hypoxemia and diagnosed with pulmonary emboli by CTA on 11/15/22.  He was heparinized.  CT showed worsening ground glass infiltrates.  He underwent bronchoscopy with BAL and TBNA which showed lymphocytic inflammation with all other Cx and infectious work up negative.  He was discharged and returned to hospital with worsening dyspnea and hypoxemia and now + for H1N1 influenza A with worsening hypoxemic respiratory failure that continues to progress despite steroids.  He did receive his Fluad influenza vaccination on September 1st 2022 with lot #346341.  He now has developed A fib with RVR and has a small pericardial effusion and intermittently mildly elevated troponin.  He is at high risk of death from this constellation of events.
Patient received covid vaccine, on the way to observation, turned and fell. Placed in a chair, automatic cuff unable to read bp, hr 40s, sats 94%, pale, diaphoretic, slow verbal responses. Observed patient, another nurse gave candy, applied ice to back of neck. Patient had another brief syncopal episode with quick recovery while seated. Code Medic called. Placed on sim lab stretcher after awake and feeling better while waiting for code team. Abrasion noted to just under chin. Bp improved to 115/74 with HR 67, spo2 100%. Code team arrived and assessed patient.  Patient condition improved, attempted standing with observation by code team. Assisted to observation room. Given sprite and more snacks. Mom and patient state both are feeling better.
Itchy rash on face and neck; A spontaneous report was received from a consumer (occupation nurse), a 47-year-old, female patient who received Moderna's COVID-19 vaccine and experienced an itchy rash on her face and neck.   There were no medical history and concomitant medications reported.  On 29 Dec 2020, approximately two hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 29-Dec-2020, about 2 hours after the vaccine, the consumer reported feeling itchy on her face and neck. She went to the mirror and there was a rash on her forehead, side of cheek and side of neck. Treatment for the event included oral diphenhydramine on the same day.  Action taken with mRNA-1273 in response to the event was not reported.   The event, itchy rash was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 47-year old female nurse who experienced a nonserious event of an itchy rash on her face and neck. The event occurred approximately 2 hours after she received the first of two planned doses of mRNA-1273 vaccine. The patient's past medical history and con meds were not provided. The rash event was considered resolved the same day. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of mRNA-1273 and the event, a causal relationship cannot be excluded. Additional information is required for further assessment.
Extreme fatigue x 1 week, dizziness, body aches, headache, 3 days after vaccination there were rashes around both eyes with swelling, rash on back of thigh and under arm, GI upset, headache & chills lasting for approximately three days. Still have rash around eyes and nares.