chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid vaccine caused me to have seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ave bad arthritis and my bones are decaying" (unspecified if ongoing); "ave bad arthritis and my bones are decaying" (unspecified if ongoing); "I bled half my body out and had an out-of body", start date: 1989 (unspecified if ongoing); "quit smoking", start date: 1983 (unspecified if ongoing), notes: quit smoking way back around 1983. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for Covid-19 Immunization; Flu vaccine (Last year I got boosted for Covid, Shingles, the flu vaccine and the phenome shot.), for immunisation. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Covid vaccine caused me to have seizures". The patient underwent the following laboratory tests and procedures: Blood test: Blood test show nothing. Clinical course: Patient does  not know if the Covid vaccine caused me to have seizures, but patient had one after the 2nd Covid vaccine and seizures supposedly after the over 65 Covid vaccine. I never had seizures in life before. Patient asked the physician if it caused the seizures but he was not sure. He said he has heard of the Shingles vaccine sometimes doing that but no proof. Last year patient got boosted for Covid, Shingles, the flue vaccine and the phenome shot. These were all given withing the allotted time spaces. Patient was now on medicine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200826844 same patient/drug, different dose/event;
Top part of right arm warm to elbow; Top part of right arm red to elbow; Top part of right arm swollen to elbow; Chills; had fever; feeling bad; Top part of right arm sore to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Top part of right arm sore to elbow), FEELING ABNORMAL (feeling bad), VACCINATION SITE WARMTH (Top part of right arm warm to elbow), VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow) and VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002821A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included METOPROLOL, ATORVASTATIN, FAMOTIDINE, COLECALCIFEROL (VIT D3), OXYBUTYNIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Top part of right arm sore to elbow) and FEELING ABNORMAL (feeling bad). On 13-Mar-2021, the patient experienced CHILLS (Chills). 13-Mar-2021, the patient experienced PYREXIA (had fever). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Top part of right arm warm to elbow), VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow), VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, CHILLS (Chills) and PYREXIA (had fever) had resolved. On 19-Mar-2021, VACCINATION SITE PAIN (Top part of right arm sore to elbow) had resolved. At the time of the report, FEELING ABNORMAL (feeling bad) and VACCINATION SITE SWELLING (Top part of right arm swollen to elbow) outcome was unknown and VACCINATION SITE WARMTH (Top part of right arm warm to elbow) and VACCINATION SITE ERYTHEMA (Top part of right arm red to elbow) was resolving.            Concomitant medication include shampoo for lupus in scalp Action taken with mRNA-1273 in response to the events was not applicable. Treatment include alcohol on arm       Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Updated reporter's address, updated first dose details, updated concomitant medications, updated treatment details, added two additional events Pyrexia and Feeling abnormal, updated stop date of the events and changed event outcome from recovering to recovered/resolved. On 16-Jun-2021: Follow-up information received on 16-JUN-2021 contains no new information.
Weakness/she was too weak to get up; Feels like there is a bruise behind her eyes; Achy muscles; Does not feel well: all she wants to do is sleep.; Temperature after second vaccine, most recent is 102 degrees; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date and second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in May2021 (reported as yesterday) both as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient does not feel well: all she wants to do is sleep, feels like there was a bruise behind her eyes, achy muscles, weakness. On 28May2021, at 3 am, her temperature was 100.1 degrees, at 10 am, her temperature was 101 degrees, and a later (reported as half hour ago), her temperature was 102 degrees (after second dose). Patient stated she had the same symptoms after the first vaccine, but then they went away. Patient ate broth and crackers. Patient took an Extra Strength Tylenol (Expiration, May2024), one 500 mg pill and a couple of hours prior, she took two Ibuprofen (lot number, expiration date unknown, stated bottle was in the other room and she was too weak to get up) for her achy muscles. Stated neither medication has been effective in improving her symptoms. Patient stated that she had every symptom, that was mentioned in important safety information guide. Patient was recommended go to a local Urgent Care if her symptoms become more concerned. Outcome for the event Fever was not recovered and for rest of the events was unknown.  Follow up needed; Information on the lot/batch number has been requested.
Patient described swelling of her arm from her elbow to her shoulder starting around 4:00 pm. Injection given around 2:30 pm. Arm swelled to nearly twice its size and was very painful. She saw her Dr the next am and the swelling had decreased. No residual problems. Her previous pneumovax was given in 1999.
received immunizations PENTACEL, PCV 7, ROTAVIUS, HEP B, on 9/14/09. broke out in persistent hives 9/17/09.  Follow-up: Hives (prolonged).
I started having pain under my right arm in the armpit area and my right breast as well. It is not completely gone yet. I had a mammogram done that showed swollen lymph nodes in the affected area. A fibroadenoma mass that was biopsied by the doctor. I saw an ob/gyn that referred me to have a mammogram and diagnostic ultrasound. The breast surgeon noted the mass and the swollen nodes. The biopsy came back benign. I have another mammogram scheduled in the near future. The pain has decreased but it is still tender and swollen. The doctor said depending on how things progress, the mass could either get removed or remain under observation.
mild coughing episodes which became progressively worse-assoc w/pos FAB for B. pertussis & lymphocytosis (emesis & choking episodes);
At 12 hours after vaccination, muscle aches all over, restless sleep with low fever, severe headache from back of head around to forehead; symptoms lasted at 24 hrs. Then diarrhea for 2 days and weakness for 1 week.
headache, fatigue,  day one and to present   body aches bad taste in mouth day 2 to present arm pain day one to day 3
This spontaneous report as received from a physician refers to her daughter of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) that was improperly stored. The physician stated that this dose was administered by the dose and route recommended in the prescribing information. No adverse events were reported. Additional information has been requested.
p/ pt recv vax approx 14 days later pt devel 50-70 lesions over body, also low grade fever
HYPOTENSION HYPOVOLEMIC SHOCK 5/1/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Woke up about 12:30am with uncontrollable shaking a jerking.  Bed was drenched.  My husband covered me in blankets.  Fell asleep and woke up two hours later needing to use the bathroom.  Stood up and fell because of dizziness and waves of nausea .  After a few hours woke up with diahrea and stomach pain.  Felt wiped out and extreme tire for a couple days.  Started with eye pain and ended up with confirmed case of shingles in left eye.
-approximately 12 hours after shot I experienced flu like aches and low grade ( 99) fever for about 24 hours. - I contracted COVID on 05/02/2022 -I had minimal symptoms (flu like aches for about 48 hours, sinus drip for 14 days and minor cough due to sinus drip for 7 days) Never had fever.
2nd dose: Diarrhea, sneezing, coughing, headache. Diarrhea has not resolved; all other symptoms have resolved   1st dose: no ae to report
PT. to exposure to pathogens in blood by needle stick. By medical order, she is given TDap vaccine for referring the patient who does not have a daily booster. After administration at ten (10) begins to develop constant cough, hoarseness and report feeling warm in the chest. Vital signs are taken T: 36.0 F, P: 87/min, Resp. 17, Saturation 100 and B/P 131/78. Dr. puts Oxygen at three (3) Ltr., Solumedrol 125 mgs., Benadryl 50mgs. IM, Therapy resp. c/ Decadron 4mgs., line IV .45% NSS 500ml- ?100 co/hr. 4:07 pm Then for the second time Solumedrol 125 mgs IV slowly. To which she begins to indicate that she feels better. An ambulance was sent to a tertiary hospital to monitor her recovery.
Started with a headache then body aches the first 4-5 hours it was bad but barrable. Then I got a splitting headache, chills and a fever of 102.0 (forehead temp). I also had a very upset stomach. I didn't vomit but I did have diarrhea. The body/head aches did last for 3-4 days. I notice a rash on day 2-3 located on my forehead and my chest. It was really red skin with bumps underneath and when I put moisturizer on it did burn really bad. The rash lasted for 24 hours and  the next day I woke up it was completely gone.
swelling on my right neck; Neck paining; dizzy; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm right on 01May2021 at 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not had take any medications within two weeks of the vaccine. 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 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:ER8733 ) via an unspecified route of administration to right arm on 10Apr2021 at 14:00 as a single dose for COVID-19 immunisation. On 02May2021 at 15:00, the patient experienced a swelling on her right neck at the place where beauty bone lies and was paining and making dizzy and causing problem to compute her daily task. Therapeutic measures were not reported. The clinical outcome of the event swelling on right neck, neck paining and dizzy was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications/No Other medication in 2weeks. Past drug history included: Macrodantin, reaction(s): "Known allergies: Macrodantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Paxlovid rebound Test negative but symptoms returned after 5 days after last dose. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Antiviral treatment and details included: product: COVID 19 Treatment, Brand: Pfizer, Treatment Start date: 12Aug2022, Treatment Stop date: 16Aug2022, indication=Treatment of COVID-19, lot number=Unknown.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
pt recvd 16AUG93 that evening lt arm was swollen, hot, tender; By Tuesday a rash had broken out @ the vax site & was itching all over; called MD & told to take DPH; seen by 18AUG;
Swollen and sore Lymph node beginning 31 Aug 2021, Daily Headache beginning  31 Aug 2021, Frequent migraine 5 over a 5 week duration, Extreme fatigue beginning 2 Sep 2021, Increase in blood clots during menstruations first cycle after shot was 25 Sep 2021, Sporadic loss in concentration, pains in legs and abdominal areas, dizzy spells, and hot flashes beginning 31 Aug 2021, Rash beginning 29 September 2021
Patient is complaining of pain int he muscle of injection site and difficulty lifting arm. He states it has gotten better as the day has gone on today. He spoke to his physician who prescribed Cephalexin for it. I asked him if it was warm to touch but he said it was not.
This spontaneous report was received from a healthcare worker (pharmacy student) referring to a patient of unknown age. The patient's concurrent conditions included an unspecified immune system disorder. The healthcare worker reported that a patient who was on immunosuppressive therapy with HUMIRA was administered a dose of ZOSTAVAX 19400 PFU (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis on 21-MAR-2017. No adverse effect reported. No additional information provided. There was no product quality complaint (PQC) involved. Additional information is not expected because there was no consent to contact the reporter.
Pain in the Deltoid- was sore the day after the vaccine was administered, but came back about 4-5 days later.  Extreme pain, loss of motility raising arm to the side.  Hurts to open and close the car door, putting on a jacket, any movement that is lateral.  I can not work out with my left arm since then.  I have gone to a chiropractor, had a massage and I am scheduled to go to PT next week, with the hopes of regaining motility with out pain.
Within an hour all of my muscles became sore--continued for a couple days, which led to migraine headache for several days.  The new and persistent symptom is tinnitus.  I have had incessant ringing in my ears since receiving the vaccine, something I did not previously experience.  The ringing has continued unabated since April 2021.
24 hours after the vaccine, 04/23/201, tachycardia- my heartbeat jumped from 60 to 280 beat a minute.  I called Medical Center,  they told me to double up on my medication- Diltiazem , which lowered my heart beat from 130 to 140 beats per minute.  , my typical is around somewhere to 60 beat per minute.  For the remainder of that week, 04/30/2021, I went back to Medical Center --I had out-patient surgery- cardio version to get my heart shocked to get it back in rhythm at the end of that week .  They diagnosed it as A-flutter  07/21-07/24  I was prescribed Tikosyn @ the Medical Center -they monitored me for 3 days, before they put me on that medication  07/23 they did another cardio version of the heart and I have been fine since, They got me back into to rhythm with the Tikosyn and I have been taking the Tikosyn ever since.
Information has been received on 08/09/2001 from a company representative concerning his 8 year old son, with no known allergies and no past medical history, who approximately two years ago, in approximately August 1999, was vaccinated with one dose of varicella vaccine. There was no concomitant medication. It was reported that on 08/02/2001, one day after playing with his cousin who had chicken pox, the pt developed herpes zoster. The zoster was reportedly distrubuted on the pt's abdomen and back, on the right side and did not cross the midline. The pt also had a fever of 101 deg. F, experienced "a lot of pain," and woke up crying. It was reported that he "is getting better now, but he is still in pain." It was also noted that the pt had several days of vomiting, headache, diarrhea and flu-like symptoms, just prior to the onset of herpes zoster. The reporter inquired whether or not that could have played a role in the development of herpes zoster. He was to discuss the possibility of collecting and submitting a spcimen for VZV identification with the child's pediatrician. Additional info has been requested.
10 year old was inadvertently administered the +12 dose of Pfizer vaccine rather than the 5-11 dose.  There were no adverse reactions.
High fever with uncontrollable shivering. The fever broke by morning followed by a headache.
liquid component of Pentacel was administered to patient without the powdered component/no AE; Initial information received on 15-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse with live follow-up on same date.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that liquid component of Pentacel was administered to patient without the powdered component/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  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 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.  Information on the batch number was requested.  List of documents held by sender: none.
This patient is a 51-year-old female who states that she got her first dose of the Covid vaccine at 2:30 in the afternoon on Tuesday. Thursday morning at 1 AM she woke up with diffuse urticaria. She has been itching and has had no relief with Benadryl. She has no shortness of breath. She has no fever or cough. She believes her allergic reaction and urticaria is due to the vaccine and she has never had anything like this before.
Was left message to return to clinic if symptoms persisted or got worse. Pt has not come in nor does she reply to messages left, stressed need to complete VAERS with more details, but she does not comply.
Had episode of being very pale for at least 15 mins. Mom noticed this as baby woke up. Was tired after immunizations and slept a lot. Temp 100. Seems to be fine now.
Pt complaining of chills and fever of 101.4 for 24 hours, post vax, with soreness but not swelling. Symptoms decreased 24 hours later. General malaise that day of injection. Symptoms gone on 3/22/2000.
70 doses of Pfizer-BioNTech COVID-19 vaccine for pediatric patients (orange cap) batch/lot# FK5618 assigned a beyond-use-date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility. The doses mistakenly administered to 70 patients on 11/26/2021.
covid vaccine breakthrough case  dose 1 11/4/21 Pfizer F63527
Nurse administered Pfizer 12+ vaccine verses Pfizer (5-11yrs). Patient waited the 15 minutes after vaccine administered and verbalized no adverse symptoms.
Day 18 post 1st dose vaccine developed sever burning/pain to rt. lat thorax. Felt as though bruising should be present but area was unremarkable. Pain intensified and tingling/ sharp twinges started. Initiated med regimen & consulted MD. DX Shingles d/t Pfizer Covid 19 Vaccine r/t genetically predisposed to Auto Immune Disorders.
3OCT95 pt recvd vax & began that afternoon w/mosquito bite size red area; continually getting larger-today 2 1/2inches by 3inches;tender to touch-even to clothes;temp up to 101 nightly since inject;referred to MD
No adverse events seen, patient observed for at least 15 minutes, 15 year old at time of injection
Sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse reaction.  Patient is under 18 years old.  Patient is 17 years old and this vaccine is indicated for 18 years and over.
Delayed reaction with sore throat, nasal congestion, feeling run down, headache. Also the well known soreness of the injection site in right arm.