chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Note:  I had covid this summer and thought that was bad.  This was equally as bad but for a shorter time.  Monday 3/29/21- A few hours after the vaccine around 5:15 pm I had a metal taste in my mouth when I ate dinner.  Overall, everything else in my body felt great.     Tuesday, 3/30/21- I woke up at 7 am , and when I got out of bed, everything started going downhill.  I was dizzy and losing ability to use my arms or hands.  My joints started giving out as I was getting breakfast for my son to go to school.  By 8:30 am, here were my symptoms,  -pain if touched any part of  my skin,  -inability to move-get dressed  -inability to use hands or arms -excruciating pain all over body - fever -excruciating joint pain  dizziness  -nothing took it away.  My pain was 9/10 with 10 being the worst.     Wednesday, 3/31/21- Wednesday I woke and still stayed in bed.  Around noon- I felt the joint paint leave, and slowly everything started getting better.  I could use my hands to text people and started recovering.   My fever broke and I could stand and walk slowly by 7 p.m.    Thursday, 4/1/21- I am up and short of breath and have tight chest and pain around heart but giving a few hours to see how I'm doing.
Client came for influenza and second Hep A on 11/7/18. She was anxious and reported when she had vaccines on 01/18/2018 her left arm became bruised and painful around shoulder, very red between her mid humerus area to elbow region (outer skin area), and she had a great deal of trouble moving her arm. Condition has since resolved. She did not have it checked out medically but did take pictures which she showed to nurse. Bruising was from injection sites very high on arm (shoulder???). Because incident resolved no further action has been taken. Injections on 11/7/18 were given IM in deltoid. Client will report any adverse reactions to health department. Client stated today's immunizations did not cause discomfort at time they were given.
This case was reported by a physician and described the occurrence of fever in a female subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  On unspecified dates in 1998, the subject received the 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown).  In 1998, at an unspecified time after vaccination with the 1st dose of Hepatitis B vaccine, the subject experienced fever.  In 1998, at an unspecified time after vaccination with the 2nd dose of Hepatitis B vaccine, the subject experienced rash and swelling.  In 1998, at an unspecified time after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced myalgia, joint pain, arthritis-like symptoms, arthralgia and arthritis.  The subject was reported to be debilitated for approximately three years.  The physician stated that the subject has undergone "an extensive work-up since then", but it was unknown if the patient was ever hospitalized.  No patient specific demographics were provided for the subject.  The physician considered the events to be disabling and clinically significant (or requiring intervention).  As of 2001, the events were resolved.  The physician considered the events to be probably related to vaccination  with Hepatitis B vaccine.
Fussiness; fever to 104 on evening of 4/21/08, leg swelling at injection site
About a week after the shot, I began feeling tightness in my chest and heart throbs in my throat along with some decrease in energy.  When I went to the doctor after a few weeks, they initially observed a PVC during the EKG.  They recommended a follow-up echocardiogram, during which the resting heart rate varied between 60 and 40 beats per minute.  Because of the abnormally low heart rate, they sent me to the ER.  Blood tests and a CAT scan confirmed that the heart was in good condition.  This was not myocarditis, but there is no explanation for the reduced heart rate other than the vaccine.
9/6/21 PMH significant forHFpEF , Aortic stenosis, COPD, CAD, DM, rectal cancer s/p resection 8/14/2020, aortic aneurysm s/p aortobifemoral repair; presented w/a concern of infected aortic bypass graft.
Pt vaccinated with Recombivax HB developed a 100% hearing loss in rt ear and a 20% to 25% loss of hearing in the lt ear. Both losses were improved w/the use of a hearing aid.
I had an anxiety attack. The physical symptoms were a severe headache, fever, vomiting, shaking, and aching body.
fell in shower; Sore Throat; fever of 101 degrees Fahrenheit; Nausea; Chills; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell in shower), OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (fever of 101 degrees Fahrenheit), NAUSEA (Nausea) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FALL (fell in shower), OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (fever of 101 degrees Fahrenheit), NAUSEA (Nausea), CHILLS (Chills) and MYALGIA (Soreness). At the time of the report, FALL (fell in shower), OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (fever of 101 degrees Fahrenheit), NAUSEA (Nausea), CHILLS (Chills) and MYALGIA (Soreness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: high (High) 101 degrees Fahrenheit.         No concomitant medications were provided No treatment information provided
Parent states child crying, fever of 101-was given Tylenol while fever decreasing.  Child shivering, not eating well. No inflammation or redness at administration sites.  Nose ad eye watery.  Is better 12/28/05.
Swollen lips and face/ tingling Difficulty swalling Difficulty breathing VERY thursty Very soar throat Racing heart rate High blood pressure Went to the ER.  They were able to lower my racing heart with a beta block.  Still suffering elevated heart rate and high blood pressure.  No prior history of heart problem or high blood pressure.
Left arm large bruise and sore.  Still bruised and sore  4/8/21 .
Muscle/leg aches. Fever that never exceeded 101.6. Dull headache. Started around 3:30 am on 4/11/2021 and all symptoms completely gone by 10:00 pm on 4/11/2021.
COVID-19 cases with onset from 7 days through 6 months post-dose 2 in BNT162b2 vaccine recipients; This case has been considered invalid as the event was outcome study.
5 days p/vax pt began running t103-104 ax; no fever @ this time 4MAR93 950AM; dad stated everyone in household has been sick;
shivering, feeling tired and weak, headache, symptoms lasted about 24 hours treatment:  bed rest,
October 5th(1 day post immunization), developed a rash on the neck that looked like  hives at approximately 4pm, then at 11pm developed shaking chills for approximately 20 minutes, went to sleep and had night sweats. On Saturday, October 8,22, developed widespread  itching with NO rash which has not stopped since. The itching ranges from mild to severe every day all day. Received a decadron shot and steroid pack which helped, but the itching never went away. Antihistamines help.
18JUL97 pt recv vax & noted lt arm swollen, sore pt eval by MD-negative fever 98.6-warm soaks-APAP, fluid
patients where vaccinated on 2May2022 and 3May2022 with expired doses of Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients where vaccinated on 2May2022 and 3May2022 with expired doses of Moderna COVID-19 Vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients where vaccinated on 2May2022 and 3May2022 with expired doses of Moderna COVID-19 Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients where vaccinated on 2May2022 and 3May2022 with expired doses of Moderna COVID-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that 13 patients were vaccinated on 2-May-2022 and 3-May-2022 with expired doses of Moderna COVID-19 Vaccine. The vial did not undergo any temperature excursions It is unknown if any of the patients experienced any symptoms. No treatment drug was reported.
Constant slight headache since the day after the vaccination.  Tylenol or Aleve takes the headache away but comes right back when medicine wares off.
I started to experienced joint and muscle pain but not one directly connected to another sporadic pain all over. It would come and go from one place to another like a small stabbing needle pain. No inflammation but lots of burning and throbbing's pain. It would move all over like one min it's sore and then gone the next and it was all over in random spots. I was also very tired and had a headache. The headache would sometimes last all day and others just for a few hours. I had flinger stiffness in the morning but it would go away after a few stretches. I saw my Dr. in Nov 2021, she did bloodwork which came back fine and she prescribed me for my Vitamin D for my bones. She then referred me to see a RC and a Bone doctor. I waited for some time and it didn't go away so that is when I made the appoint to see my doctor.
Pt developed acute hoarse voice; Ear redness; Slight tongue swelling; This is a spontaneous report received from a contactable physician. A 51-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an intramuscular route of administration, administered in Arm Left on 05Mar2021 14:30 (at the age of 51-years-old) as dose 1, single for COVID-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced Pt developed acute hoarse voice, ear redness and slight tongue swelling on 05Mar2021 14:30. Patient received treatment received for the adverse event as IM epi, anti histamine and steroid. Patient visited Emergency room/department or urgent care. The outcome of the events was reported as recovered in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Pain as t injection site.  Swelling and redness, about 2 inches below injection site.
R arm soreness onset approx 4 hours after vaccine admin. Tolerable. Body aches, headache, malaise, fatigue, stomach upset approx 24 hours after vaccine administration, lasting until approx 48 hours after vaccine administration.
101 degree fever, swollen lymph nodes, rash on L side of neck/face.
nausea, feeling flushed, dizzy evaluated by EMTs - VSS and wnl employee continued to feel unwell
VOMITING/EMESIS; SHAKES; LEGS NUMB; FEVER; WEAKNESS; TIREDNESS; UNABLE TO WALK; This spontaneous report received from a physician concerned an 18 year old male. The patient's height, and weight were not reported. The patient's past medical history included Lyme disease, and seizure, and concurrent conditions included attention deficit hyperactivity disorder, intermittent asthma, migraines, psoriasis, and penicillin allergy, and other pre-existing medical conditions included currently not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported,1 total administered on 08-APR-2021 at 14:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021 around 19:30, the patient experienced vomiting, had fever, shakes and complained of numb legs and was unable to feel them. He was instructed by his physician to go to the nearest Emergency room (ER). The patient visited emergency room or department and physician office for treatment of the events. He went to ER but was unable to walk at that time and was carried in. The patient was evaluated, had normal chest X-ray (CXR), temperature up to 104, had emesis, underwent rapid covid test which was negative. He was given intravenous (IV) fluids, Zofran, Tylenol and was discharged home. It was reported that the patient was doing better but with continued tiredness, weakness, his legs were feeling better, temperature was down, coherent and was tolerating fluids. Laboratory data included: Body temperature (NR: not provided) 104, COVID-19 antigen test (NR: not provided) Negative, and CXR (NR: not provided) Normal. Treatment medications (dates unspecified) included: paracetamol, and ondansetron. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting/emesis, fever, shakes, and legs numb, had not recovered from weakness, and tiredness, and the outcome of unable to walk was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420466-covid-19 vaccine ad26.cov2.s-vomiting/emesis, shakes, legs numb, unable to walk. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210420466-covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Started with body aches and fatigue, Diarrhea, and dizziness have been persistent after a week of vaccination.
Noted small erythematous papule on volar aspect of R proximal wrist day after vaccine, which subsequently developed into vesicle and burned. Resolved within one week.
adipose necrosis-1x1cm <less;pt exp dimpling of thigh;dimpling is a result of necrosis of fatty tissue;
Patient has extreme pain at site of injection and affected arm (L), fever, and limited mobility of extremity.
Chills, Body aches, headache, redness and swelling on right upper arm.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age. On an unknown date, the patients were vaccinated with (Merck) VARIVAX, 0.5 ml/ once, subcutaneously (lot number not provided), which was exposed to temperatures outside of recommended condition and no adverse events were reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected.
pt recv vax 27OCT97 & c/o rt arm pain w/movement, tender to touch, swollen, warm, no redness;febrile over night to 101.7, pain & erythema devel @ inj site w/swelling & fluid in rt bursa;dx as cellulitis per infectious disease specialist;
By 11pm, I was lying in bed shaking and shivering from head to toe. I had a low-grade fever. The highest it got was 100.7 and it remained around that temperature for 3 days. I remained in bed the entire time and took Tylenol to treat it. I also experienced nausea and severe diarrhea, but I started to feel better around day 4. I was back to 100% around day 7.    I had an ear infection before I got the vaccine and was experiencing  issues, so I went to Urgent Care in April and they gave me a shot in the backside and put me on steroids. On May 25, I went to see my PCP and he put me on antibiotic steroid ear drops. It was discovered that I now suffer from seasonal allergies and both doctors are thinking that the infections are due to that.   Due to my elderly parents and high-risk soon, I also received the Pfizer vaccine and have no issues to report:  Dose 1 - 4/24/21 - EW0162 Dose 2 - 5/15/21 - EW0170  Please feel free to contact me at anytime with any questions.
expired DAPTACEL was administered with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 year old male patient to whom expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination (immunization).  On 29-Jun-2023, the patient received 0.5 mL expired dose 4 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C5893AA; Expiry date: 21-Jun-2023) via intramuscular route in left thigh for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired daptacel was administered with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer-sponsored program (159558). A 71-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8730, expiration date: Jul 2021), at the age of 71, on Mar 25, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had vaccination site pain (a little soreness on the injection site), with outcome of unknown. Additional information: The patient mentioned she didn't have a reaction, only a little soreness on the injection site. She was scheduled to return on Apr 15, 2021 for her second shot. However, she missed it. She wanted to have her second dose rescheduled, and wanted to know where she can get her second shot. No follow-up attempts possible. No further information expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patients) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patients).    Patient age was reported as 57 years and 5 months.  Concomitant medications details were not reported by the reporter.  Reportedly, the number of patients at facility that received this Moderna vaccine between 08-Apr-2022 and 15-Dec-2022. Additionally, In the second list, reporter discovered a past lot that had also been expired and administered to patients with batch number.    Treatment details were not reported by the reporter.
Patient received both vaccines and after 10 minutes she fainted on the floor.  Was transferred to gurney and patient was noted to be awake after she fell, accompanied by mother. Vital signs were stable (BP 91/60, HR 106, T 98.7, O2sat 99%).  Ice pack was applied to redness on forehead. Patient is alert and oriented. Denied pain. Was monitored for 20 more minutes. Cleared by MD to be sent home.
Vaccine administered at 1115. At 1130 another adult in waiting area summoned for help verbalizing he thought she was going to pass out. LPN first one to the patient and called for assistance when patient not responding. Pt with eyes open and looking at staff, but noticed full body weakness and not speaking. 2 person carry to treatment and called for code blue adult. Placed on treatment bed. Remained incoherent. No loss of consciousness. BP 122/76 HR 88. O2 sats 100% on room air. After 3 minutes was able to tell us her first name. Slurred speech. Not making eye contact. Transferred via gurney to ED.
Every time it gets hot, he is itching/itching spells anytime he gets hot or is out in the heat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "Every time it gets hot, he is itching/itching spells anytime he gets hot or is out in the heat".  Additional information: Every time it was getting hot, he was itching. The patient was asking what he should do or if this would be related to the vaccine. He had been having itching spells the last 3 to 4 weeks, anytime he was getting out, or was out in the heat, or when the sun hit him.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mom stated pt was irritable, sensitive to touch on legs; pt had no fever but had a fever during the noc; there was no local swelling or redness; MD counseled over phone;
Within seconds of receiving the vaccine, the injection site developed was huge almost baseball size, and it's still swollen up my arm to the base of my neck, I've had a fever, which is gone away, a rash, headache, chills, dizziness and weakness. I had to leave work because I couldn't work with the headache.
Started getting nausea and started doing projectile vomiting. Went to the ER and they gave her some meds that stop it but the vomiting came back. She vomited 3 to 4 days in a row.
1-2 minutes after he received shot he had syncopal episode and hit his head on window sill. He regained consciousness within few seconds. He BP was 60/40. He improved with lying flat and drinking water.