chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had 100.4F fever; feeling nauseous; cramping in her legs; chills/chills really bad; joint pain; injection site hurting really bad/site were it was given was hurting really bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 10:00 (Lot number: 30130BA) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1:  lot number: EW0179.), administration date: 02Aug2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "cramping in her legs"; CHILLS (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "chills/chills really bad"; ARTHRALGIA (non-serious) with onset 14Sep2021 02:30, outcome "recovering", described as "joint pain"; VACCINATION SITE PAIN (non-serious) with onset 13Sep2021, outcome "not recovered", described as "injection site hurting really bad/site were it was given was hurting really bad"; PYREXIA (non-serious) with onset 14Sep2021 07:00, outcome "unknown", described as "had 100.4F fever"; NAUSEA (non-serious) with onset 14Sep2021 07:00, outcome "not recovered", described as "feeling nauseous". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course:She had the second injection yesterday. She got up during the night with chills really bad, cramping in her legs, and joint pain. The site were it was given was hurting really bad. She has a 100.4 fever and was nauseous. She wanted to know is it normal or something she should be seen for. Joint pain had improved and was a little better. When she got up she started getting nauseous. She didn't notice it before that. It was ongoing. Site were it was given was hurting really bad,it was ongoing and persisting since it feels the same. When she woke up she realized she felt warm and took her temperature.  No follow-up attempts are possible. No further information is expected.
SEIZURES; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: T821286, expiry: unknown) dose was not reported, 1 total administered on 12-JUL-2021 for prophylactic vaccination on left arm. Concomitant medications included metformin.  On 23-JUL-2021, the patient first experienced seizure where patient was shaking in the driveway and past out. Patient reported that on 25-JUL-2021, the patient's wife found him on his bed in a daze. Patient's wife called the ambulance to hospital where patient was admitted for 8 days. Patient was discharged on 01-AUG-2021. Patient was only on the medications that they gave in the hospital (list was unavailable to him at the movement). Patient reports that this morning (07-AUG-2021) that patient was on bathroom floor and not sure for how long.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from seizures. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210815132-covid-19 vaccine ad26.cov2.s -Seizures. 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).
ONSET WAS 2 HOURS AFTER VACCINATION. SEVERE MUSCLE AND JOINT PAIN; HEADACHE; CHILLS; FEVER; EXTREME FATIGUE (COULD NOT STAY AWAKE AND SLEPT 22 HOURS/DAY FOR 3 DAYS). COULD NOT LIFT ARM IN WHICH VACCINE WAS INJECTED FOR ALMOST A WEEK. CONFUSION AND WEAKNESS. PATIENT MISSED 3 DAYS OF WORK (VACCINATION ON SUNDAY; COULDN'T RETURN TO WORK TILL THURSDAY, MARCH 28, 2019.
fatigue; low-grade fever (101 F); chills; headache; booster; injection site soreness/warmth starting 20Dec2021; injection site soreness/warmth starting 20Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Dec2021 14:15 (Lot number: FH8027) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: peanuts" (unspecified if ongoing); "known allergies: blueberries" (unspecified if ongoing), notes: known allergies: blueberries; "known allergies: CT scan dye" (unspecified if ongoing), notes: known allergies: CT scan dye. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CALCIUM CITRATE/VITAMIN D. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 62 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 62 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 14:15, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 20Dec2021, outcome "recovering" and all described as "injection site soreness/warmth starting 20Dec2021"; FATIGUE (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "fatigue"; PYREXIA (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "low-grade fever (101 F)"; CHILLS (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 21Dec2021 08:00, outcome "recovering", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site warmth, fatigue, pyrexia, chills, headache.  Additional Information: The patient had no other vaccines in 4 weeks. The patient did not have COVID-19 prior to vaccination and since the vaccination was not tested for COVID-19.
Briefly after vaccination, patient fainted. Immunizer was able to catch patient to avoid any injury. She regained consciousness within 1 minute and was alert within 2 to 3 minutes after episode. Patient has no history of fainting after vaccination, but does have a history of fainting with blood draw and IVs. Patient was fully alert shortly after episode and was able to leave with a family member
fever; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a month after receiving Shingrix, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were recovered/resolved.   It was unknown if the reporter considered the fever and injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix vaccine on right arm and experienced fever that lasted for 24 hours and pain at injection site for 4 days. The reporter did not consent to follow-up. No further details were provided. For tolerance of 2nd dose refer linked case US2019GSK103699.
I woke up around midnight to an intense seizure-like event.  Every single muscle in my body was violently, rapidly and painfully having spasms.  Even the small muscles you don't think about.  I had almost no control over my muscles.  The spams kept coming in rapid waves.  The pain was a 10 on the subjective 1-10 pain scale.  It also felt like my body temperature was plummeting and I could not stop shivering, as though I was going into hypothermia.  I live alone but could not cry out for help anyway.  I tried to get out of bad but I just rolled over and fell onto the floor, bruising myself.  I was unable to move for a few minutes.  I could not see my cell phone and did not know where it was.  Not that I could have used it anyway.  After a while I crawled to the adjacent bathroom where I turned on the shower hot water and somehow managed to crawl into the tub.  That seemed to help the feeling of freezing and the shivering subsided a bit.  There seemed to be a lull in the constant spams so I tried to stand up when another intense wave of spasms came over me and I fell over bruising myself badly.  The pain became so intense I passed out.  I remember believing that I was going to die. When I woke up there were no spasms and I was covered in sweat, my temperature felt more normal.  I felt completely drained of energy, my whole body hurt and felt stiff.  My nerves felt tight and my muscles all very sore.  I drank a lot of fluids, ate something and rested.  I have agoraphobia and no health insurance, which is why I did not seek medical attention.  I thought that reporting adverse reactions could only be done though a hospital or doctor, that's why I waited until now to report.  In the following days after the reaction I felt stiff and tight in my nerves, like I had lost some of my high dexterity that I am accustomed to.  After a while those feeling subsided a little.  To this day I my nerves feel stiff and tight and it feels like my muscles have not fully relaxed since then.  This has resulted in a lot of aches and pains since in my head, neck, back, joints.  My muscles and nerves still don't feel normal, I feel this stiffness and tightness to this day.
Achy, flu-like symptoms, low grade fever, tired. Report 2001017447-1 describes reactive arthritis in a pt who rec'd Lyme disease vaccine recombinant OsPA (Lymerix). This report was rec'd from the pt and has not been verified by a physician or other HCP. The pt had no relevant medical history. Specifically, he had no history of drug allergies, gout, psoriasis, Crohn's disease, or Lyme disease. He had no family history of RA, or lupus erythematous. There were no concurrent medications. The pt rec'd his 1st injection of Lymerix on 4/17/00. He rec'd his 2nd injection of Lymerix approximately 1 mo later, in 5/00. He had no adverse experience following receipt of these 2 injections. He rec'd his 3rd injection of Lymerix on 4/3/01. 2 days later, on 4/5/01, he experienced flu like symptoms, became achy all over, developed a mild low grade fever., and felt tired. These events resolved after 3 days. On 4/9/01, 6 days post immunization, he began to experience joint pain in both ankles. The joints were not red, swollen, or warm. During the first week of 5/01, he was seen by his podiatrist, who noted edema in the second toe on the L foot. The pt was given a non specific diagnosis. Th podiatrist prescribed a 14 day course of celecoxib (Celebrex), which was noneffective. The pt ret'd to the podiatrist approximately 2 wks later. The podiatrist referred the pt to his primary physician. The pt was seen by his primary HCP on 5/16/01. The physician prescribed doxycyceline 100mg daily which was noneffective, The pt ret'd to his primary physician a few days later because the ankle joint pain persisted. He had also begun to experience hand pain, wrist pain, and pain in both hips. He was referred to a rheumatologist. The pt was seen by the rheumatologist on 5/22/01. Physical exam was performed. No joints were noted to be red, warm or swollen. No joint fluid was obtained. No lab evaluations were performed. The rheumatologist increased the doxycyceline dosage to 100mg twice daily, and prescribed ibuprofen 800mg 4 times daily. The doxycycline was noneffective the ibuprofen provided slight improvement. The pt was then seen by an infectious disease specialist. Unspecified test for Lyme disease were again reportedly negative. The infectious disease specialist discontinued doxycycline therapy and referred the pt to his primary physician. At the end of 5/01, the pt was seen by his primary physician and by an internist. A diagnosis of reactive arthritis was reportedly made and ibuprofen therapy was continued. The pt was seen by his primary physician the week of 7/2/01, no change in dx or tx. On 7/13/01 the pt rep'd he could no longer hike or lift weights because of reactive arthritis. He rep'd that he could no longer work a P/T white water raft guide. Therefore, the pt is considered disabled.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and lymphedema. On an unknown date, the outcome of the injection site swelling and lymphedema were unknown. It was unknown if the reporter considered the injection site swelling and lymphedema to be related to SHINGRIX. Additional details were reporter as follows: The age at vaccination was not reported. The field representative called to report adverse events that three different patients experienced on SHINGRIX as reported to her by the nurse. The patient experienced lymphedema and swelling at the injection site. The field representative had very limited information. Attempted to call nurse twice to get further information on the events but was not able to reach her. She also stated that nurse had reported the event to VAERS. This was 1 of 3 cases, reported by the same reporter.
Itching for one week with raised bumps that traveled from my ankles to my calves ti my front thighs (both sides).  This occurred over a 7 day period.
sore arm/ arm hurting bad; Couple hours when checked had fever 97.1 degree; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/ arm hurting bad) and PYREXIA (Couple hours when checked had fever 97.1 degree) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A0A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to codeine), Drug allergy (allergic to aspirin), Chronic kidney disease stage 3, Anxiety and Depression.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm/ arm hurting bad) and PYREXIA (Couple hours when checked had fever 97.1 degree). At the time of the report, PAIN IN EXTREMITY (sore arm/ arm hurting bad) and PYREXIA (Couple hours when checked had fever 97.1 degree) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Pyrexia: 97.1 (High) 97.1.         concomitant medication was not provided. Treatment information was not provided.    This case was linked to MOD-2021-048252 (Patient Link).
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ, orally (lot number and expiration date and dosage not provided. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The vaccine was administered even though he was only 16 years of age. He tolerated it well and mild (typical) post-vaccine side effects. Per CDC guidelines, he returned for a second dose (on 4/20/2021.)
Site: Pain at Injection Site-Mild, Systemic: Patient lost conscious for 4-5 seconds. Mild, Systemic: Seizure-Mild, Additional Details: Dad stated his daughter experienced the same symptoms when she was playing and fell on her back a few years ago. We called 911. EMS personnel checked her out and took her to the local hospital for observation.
heavy chills; body shaking; fever; sweating; painful headache; arm receiving vaccine has been very swollen; very hot to the touch; not able to get up and about to do daily routine; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection (Batch/Lot Number: EWD167), via an unspecified route of administration, administered in Arm Right on 05May2021 at 13:00 (at the age of 72-Years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included chronic lymphocytic leukaemia and Covid-19 prior to vaccination. No known allergies were reported. Covid was not tested post vaccination. No other vaccines were given in four weeks. Concomitant medication included atorvastatin 10 mg taken for an unspecified indication, fluoxetine 20 mg taken for an unspecified indication, alprazolam 1 mg taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection (Batch/Lot Number: EPT533), dose 1, via an unspecified route of administration, administered in Arm Right on 14Apr2021 at 13:00 (at the age of 72-Years-old) as DOSE 1, SINGLE for covid-19 immunisation. On 06May2021 at 01:30 approximately 12.5 hours after vaccination, the patient experienced heavy chills, body shaking, fever, sweating, painful headache, arm receiving vaccine has been very swollen for 3 days, very hot to the touch, not able to get up and about to do daily routine. Patient had heard people mention having reactions, but most are having vaccination reactions after the second Pfizer vaccination. Patient don't know of anyone having reactions after both vaccines. At the time of this report, the outcome of events was unknown.  No follow-up attempts are possible. No further information is expected
Patient reported to onsite health clinic to see nurse at 1930. Complaints of not feeling well. Vomited then dyspnea. Went into cardiac arrest, AED used x1. EMS called at 1945. CPR, intubation until 2055. Time of death 2055.
GOT COVID; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with product quality complaint: 90000223173 This case, from the same reporter is linked to 20220350967.
Pain in the arm, could not lift the arm the following day, aching joints, pain radiating from shoulder & down arm still on 4th day, no visible injury.
Information has been received from a certified nurse midwife through the Merck pregnancy registry concerning a white female with a history of 3 pregnancies and 1 live birth who on 29-JUL-2002 was vaccinated with varicella virus vaccine live (site unknown). Concomitant therapy that day included rubella virus vaccine live (MSD) and hepatitis B virus vaccine rHBsAg (yeast) (MSD). On 08-JUL-2002, the patient had been tested for antibodies and the results were negative. Subsequently, she became pregnant (LMP = 12-JUL-2002; EDD: 19-APR-2003) and on 27-APR-2003 delivered a normal, healthy male baby weighing 8 pounds  8 ounces. There were no complications or abnormalities during pregnancy or during labor/ delivery. The patient had a repeated, scheduled C-section. There were no reported medications used during the patient's pregnancy. On 18-NOV-2002 an ultrasound was performed for a fetal survey (18.2 weeks). Amniocentesis and MSAFP were reportedly declined. On an unspecified date, the patient had an abnormal pap smear with carcinoma in situ. There were no other reported diagnostic tests performed during pregnancy. it was noted that the patient did not have a local reaction at the injection site, varicella (chicken pox) symptoms post vaccination, or herpes zoster (shingles) symptoms post vaccination. The newborn infant did not feature any congenital varicella zoster syndrome (cutaneous scars, limb hypoplasia, eye or CNS malformation, or neurologic deficits.
inadvertently administered an expired dose of daptacel with no reported adverse event; Initial information received on 28-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was inadvertently administered an expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 polio vaccine (Polio Vaccine) for Prophylactic vaccination.  On 27-Jun-2023, the patient received a dose 2 dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection lot C5893AA expiry date: 21-jun-2023 via intramuscular route in the right thigh for prophylactic vaccination (immunization).  On 27-JUN-2023 the patient developed a non-serious inadvertently administered an expired dose of daptacel with no reported adverse event (expired product administered) on the same day following the administration of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered an expired dose of daptacel 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 guidelines. 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.
5PM face flushed gave APAP 8PM t104 R cont APAP every 3 hrs, 4MAR 8AM awoke eyes staring, jerking of head & arms x 30 sec; color dusky lips cyanotic, did not respond to voice;  to OPD-t105.6 R on ATB temp up to 104 until 6MAR then down;
Each evening I have a severe headache. Ibuprofen helps a little but not much. It feels like a sinus headache and hurts in the front and top of my head. I have an appointment with my PCP this Wednesday and plan to discuss with her.
that day, headache and arm soreness started.  Headache and soreness tolerable with Tylenol for 2 days.  Day 8 - on 01/06/21 - fingers, hands, and feet incredibly sore.  Painful to do anything with fingers - staple, put on earrings, grip anything, etc.  Feet hurt to walk.  Joints in fingers swollen - can't wear rings.    NP is my primary care - but she didn't administer the vaccine.  Vaccine was done at Facility - offered and administered  by the pharmacist.
Pulsating heart sounds on first and second day; then became pulsing buzzing sound on and off shorter and longer at times.
Low grade fever for 2 days post vaccine up to 100.3 first day and 2nd day 99.5 Headache for both days - even though taking ibuprofen and Tylenol  Achy  Runny nose
Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Systemic: Fainting-Mild