chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got a low grade fever exactly two weeks from the vaccine and then he started to develop joint pain. He got severe migratory arthritis in his lower joints and it moved from knees, hips and right ankle depending on the day. He could not walk at all for over a week and we had to take him to the ER, several specialists and my husband had to carry him around the house because he could not walk from the severe pain. We had to use a wheelchair to get him to the doctor's offices and this was all happening to a very healthy 8 year old boy who had never had any joint pain before. He was taken to the ER, took motrin, tylenol which did not help his pain at all. He threw up from the naprosyn liquid but he was finally able to take naprosyn tablets with prevacid and he could get relief from the pain. He also started to get frequent urination and was tested for diabetes and bacterial infection. Everything came back normal. He was tested for RA, strep, CBC and a battery of blood tests and every single test was normal. He also had x rays of all the affected joints and they came back normal. He had pinkish cast to his eyes during the height of the pain and he also had slight swelling of his right knee throughout the migratory arthritis. After 2-3 weeks, he improved and he was able to stop the pain medicine. Two doctors confirmed that this was due to a reaction to the flu shot and we are never getting one again. We have heard of several other similar severe reactions to this flu shot this year. Patient has had flu shots every year since he was 2 years old and he has never had such a reaction, ever! Something is up with the vaccine this year. Too many people are getting bad reactions to it!
Vaccine was given to a 16 year old. Patient was monitored for 15 mins post vaccination. Patient showed no signs/symptoms of a reaction.
Swollen left ankle/another swollen ankle; Ankle pain/Joint hurting really bad/Joint ache; feeling generally sick; Fever; Chills; Aches; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (feeling generally sick), JOINT SWELLING (Swollen left ankle/another swollen ankle), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 PRAVASTATIN, HYDROCHLOROTHIAZIDE, Cartia, Aspirin, COLECALCIFEROL (VITAMIN D3) and METFORMIN.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced MALAISE (feeling generally sick), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches). On 01-Apr-2021, the patient experienced JOINT SWELLING (Swollen left ankle/another swollen ankle) and ARTHRALGIA (Ankle pain/Joint hurting really bad/Joint ache). At the time of the report, MALAISE (feeling generally sick), JOINT SWELLING (Swollen left ankle/another swollen ankle), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Aches) and ARTHRALGIA (Ankle pain/Joint hurting really bad/Joint ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
20 min after injection: lightheaded, dizziness, nausea, lowered blood pressure., chest pain. This lasted for about an hour. Then for several days after injection: flu-like symptoms of muscle/joint pain, mild fever, sore throat, chest pain, exhaustion, mild pain at injection site like a sore muscle. Patient is still feeling mild flu-like symptoms, 3 days after injection.
Mild fever, chills, lethargy, malaise - lasted 24 hours Tinnitus in both ears - still present with no abatement (almost 2 years later)
No known adverse effects; patient received a dose of PROQUAD in error. (This is not a case of product confusion); This spontaneous report was received from a nurse refers to a 69 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R021232, expiration date: 21-JAN-2020, therapy type: rha (strength, anatomical location not reported) subcutaneously in error (wrong product administered) and that was not a case of product confusion. The nurse was distracted by someone and grabbed the wrong vaccine by mistake. No adverse effects were reported. No product quality complaints were involved.
Elbow and arm started to itch and then hurt, swollen, and turned red. Two rounds of antibiotics, injection of ceftriaxone sodium and pills cephalexin and pills sulfamethoxazole-trimethoprim for 10 days each Diagnosed with cellulitis.
72 HOURS AFTER HER BOOSTER ADMINISTRATION, PATIENT BROKE OUT IN TO A RASH FROM HER JAWLINE TO HER BELLY. SHE DID NOT HAVE A RASH AFTER THE FIRST 2 DOSES.  SHE WENT TO URGENT CARE CLINIC BECAUSE SHE WAS AFFRAID THE REACTION WOULD GET WORSE. THEY ADMINISTERED A STEROID AND ANTIHISTAMINE AND THE RASH IMPROVED WITHIN 24 HRS
Patient collapsed while eating breakfast at home.  He was taken to the ER and pronounced dead.    12/18/07 Reviewed hospital ER records which reveal patient in usual state of health on 11/27 when coughed & then collapsed at home.  Was unresponsive in ER & resuscitation unsuccessful. ER COD stated as sudden cardiac death.  1/21/08 Reviewed autopsy report which states COD as complication from congenital cardiac disease (probable arrhythmia.
This spontaneous report has been received from a license practical nurse concerning a 18 year old patient (gender unknown) who was vaccinated on 13-AUG-2014 with a dose of GARDASIL (Lot # J006850, exp. date 31-MAR-2016) (dose and route not specified). It was reported not all doses with this lot # were affected by the temperature excursion, it was not known which clients received the affected doses. None of the clients have reported an adverse event from receiving the vaccine. This is one of several cases from the same source. Additional information has been requested.
On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 20-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red spots on her chest), VACCINATION SITE PRURITUS (Itching on arm), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   At the time of the report, RASH ERYTHEMATOUS (Red spots on her chest), VACCINATION SITE PRURITUS (Itching on arm), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
Mom was withi pt in exam room he had rec'd the vaccine (sitting on side of exam table), had syncopal episode - pale, diaphoretic, frontal BP 80/42. When we tried to sit him up - started to jerk and eyes rolled back in his head. Repeated BP, gave sips of sugary soda - after 1 hr. color returned to pink, alert and oriented, BP normal and d/c home.
Redness and swelling at site of the injection, soreness.  Taking Advil.
I received my shot on 7/31/2021. On 08/01/2021 around 2:30pm I started feeling nauseated and weak.  I began to feel a little better around 7:30pm.  On 08/02/2021 I woke up around 6:30am with a headache and feeling sick to my stomach.  I went to work thinking it would get better but it didn't. Around  2:00pm my headache was gone.  Then around 5:30pm my headache came back and wouldn't go away even after I took some ibuprofen.  I woke upon 08/03/2021 around 6:00am and still wasn't feeling my best but it wasn't as bad as the other days.  I still had a slight headache and my arm was still sore including across my chest and shoulders, so I took some ibuprofen.  I arrived at work around 8:55am and before I got out of my car I noticed my arm was red, swollen and hot to the touch.  I still currently have a headache and my arm is still red and hot to the touch and I still have soreness across my chest and arms.
Fatigue, myalgias, chest tightness (early repol on ECG, possible mild ST-T changes).
Pt recv vax on 12/2/98; on same day pt exp listlessness, fever (104.2F); tx=Tylenol/Advil, cool bath; pt imp 12/3/98
Legs started to give out and then became very weak lower body, nerves and muscle weakness, numbness and tingling and serious falling and instability began on 2/16/2021 continuing to present  Prednisone treatment - no diagnosis/ walker/ wheelchair needed - home health care needed with home physical therapy and occupational therapy
Information has been received from a health professional concerning her 14 year old female family friend who at approximately 7 years old, in approximately 1997, was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Over Christmas 2003, the patient had an outbreak of zoster on the face which spread to an eye. The nurse was unsure which eye. The patient went to an urgent care physician to report this and she was diagnosed with zoster and told to follow up with a primary care physician. The report indicated that the patient had made a full recovery. No product quality complaint was involved. Additional information has been requested.
Left sided facial weakness,  tongue feels numb on left side, speech just a little off but no left arm weakness or anything else. Ear pain on the left side and headache. CT Head done on 2/26/21 at ER resulting in no acute intracranial process. Diagnosed with Bell's Palsy and started on 7 days of Valacyclovir HCL 1 gram - 3 times a day and Prednisone 20mg - 3 in the morning for 5 days. Completed course of Prednisone morning of 03/03/2021. Symptoms no better with medications.
chills; body aches; Skin hurting; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200), via an unspecified route of administration in the left arm on 09Mar2021 at13:00 (at the age of 69-years-old), as a unknown single dose for COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications included Zafirlucast (MANUFACTURERUNKNOWN),Fluoxetine(MANUFACTURER UNKNOWN), Ropinerol(MANUFACTURER UNKNOWN),XIIDRA, Acyclovir (MANUFACTURER UNKNOWN),low dose Aspirin (MANUFACTURER UNKNOWN), for an unknown indication from an unspecified date and unknown if ongoing. On 10Mar2021, the patient experienced chills, body aches, felt like skin was hurting. The patient was took Tylenol (MANUFACTURER UNKNOWN) for the treatment for adverse events. The clinical outcomes of chills, body aches, skin  hurting was recovered. No follow-up attempts are needed. No further information is expected.
pressure rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Nov2021 00:15 (Lot number: FK5127) at the age of 34 years as dose 1, single for covid-19 immunisation at pharmacy or drug store. Relevant medical history included: "Environmental allergies" (unspecified if ongoing), notes: Environmental allergies; "ADHD" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: Known allergies:Amoxicillin. Vaccination history included: Flu vaccine (Location: Right shoulder), administration date: 09Oct2021. The following information was reported: RASH (non-serious) with onset 11Nov2021 17:00, outcome "not recovered", described as "pressure rashes". The event "pressure rashes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Started having pressure rashes that haven't resolved. Unsure if related to vaccine, methylphenidate, or an autoimmune disorder we weren't previously aware of (waiting to see an allergist). We just want to provide information in case it is an adverse reaction not discovered during testing. Ae treatment:5 days of Prednisone, Zyrtec, and Benadryl.  No follow-up attempts are possible. No further information is expected.
1616- Patient received injection and immediately fell forward from chair and struck plastic chair with right forehead while falling to floor. Staff called for help.    1617- Patient lying on side, not responding to voice or tactile stimulation for 30-60 seconds. Patient spontaneously opened eyes, sat up, and asked 'where...what'. Pulse ox placed on patient HR 50, O2 sat 99% on RA.  Code team arrived. BP 86/45 HR 50. Patient pale, diaphoretic. MD advised lowering head between knees. COld pack placed on back of neck. Pt offered juice, patient drinking juice. Patient with small closed laceration above right eyebrow.    1620 HR decreased to 48. This NP advised patient to lay down, feet elevated. Band-aid placed on laceration. MAE, Ice pack placed on forehead. Patient reports mild pain on forehead that increases when pressure placed on forehead.    1622- A&O x4, pale. BP 109/67 HR 58, O2 sat 100%. Patient consented to notifying spouse of his condition. Staff member sent outside to notify spouse.    1627- A&Ox 4, skin pink, BP 114/75, HR 54, 02 sat 98%.. Patient offered more juice. Denies dizziness, reports mild HA. Dsg to forehead clean, dry and intact. Spouse and children at patients side. Patient interacting. Spouse reports patient "didn't eat much and was very nervous".    1632- A&Ox4, skin pink, dry. BP 119/79, HR 55, O2 sat 100%.. Discussed  plan with patient to gradually have patient sit up and that we advise following up at urgent care today. Worked with staff to find urgent care. Spouse states she will drive patient.   1634- A&Ox4, skin pink, warm, and dry. Patient sitting up. BP 120/76, HR 61, O2 sat 98%. Patient denies dizziness, or nausea. Reports MIld HA and forehead pain.    1640- A&Ox4 skin pink, warm, and dry. Patient sitting up. BP 108/73, HR 65, O2 sat 98%.    1646 HR 62. Patient denies dizziness, or nausea. Reports MIld HA and forehead pain. Patient wanting to stand up. Patient assisted to feet, denies dizziness, gait steady. Standing BP 123/70, HR 54, O2 sat 99%.   1650- transported via wc to private vehicle. Patient ambulated and seated in car without c/o. Address for Urgent Care provided to patient's spouse. Patient and spouse state understanding of recommendation for further follow up at urgent care.
Information has been received from a health professional concerning a 10 year old white female with no known allergies who on 1/2/95 was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient's mom called on 3/25/04 to report that the patient started with chicken pox on 3/23/04. The mother was using aveno oatmeal bath and calamine lotion to the spots. Additional information has been requested.
First severe hyperactivity; trouble sleeping; swollen arm at injection site. 10 pm muscle aches and  low-grade fever. 12 pm vomiting for 10 hours. Severe fatigue. Headache.
body aches; Fatigue; Joint ache; Nausea; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 17:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications were not reported. On 16Mar2021, the patient received varicella zoster vaccine vgE cho ( SHINGRIX ) vaccine 4 weeks prior to the COVID vaccine. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unknown date the patient underwent nasal Swab test and the result was tested negative. On 31Mar2021 at 10:00, the patient experienced fatigue, body and joint aches, nausea and dizziness. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, body and joint aches, nausea and dizziness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain in armpit that radiates down arm. Heavy feeling in arm and numbness in wrist and fingers.
02/18/2021 vaccination Later that afternoon, I experienced chills and shaking. It came on suddenly, I couldn't even read what was on the paper I was shaking so bad. This lasted for 20 minutes. I did have muscle aches that came on at night and lasted thru the course of sleeping.
PATIENT GOT DIZZY AND PUT HEAD DOWN. HE THEN QUICKLY RECOVERED AND WAS FINE. WE MONITERED PATIENT FOR 30 MINUTES AFTER AND HE WAS OK. HIS FRIEND DROVE HIM HOME.
Severe pain in arm - shoulder to  2'" above elbow.  Much difficulty lifting arm.  Symptoms have lasted for days  but are slowly lessening.  Large rash in upper region of arm.  The upper arm turned yellow and the rash moved slowly to the lower part of the arm during the past two days.   The day after the inoculation I had intestinal issues.  The past few days I have had an overall malaise.  Today a sore throat. I did take a picture of my arm after each event.  This experience is different from the first vaccination although I did have pain and rash.
mom states leg was red & swollen about 1-2 days p/vax given;got worse about 1mo later  & was told leg needed to be drained;
Vx exposed Freezing  temperature 28.6F; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis, flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 15th October 2022, the patient received Havrix, Engerix B, Boostrix, Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Shingrix and Menveo. On an unknown date, unknown after receiving Havrix, Engerix B, Boostrix, Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Shingrix and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-DEC-2022. Reporter's Comment:  The pharmacist reported that below recommended temperature of 28.6F for Havrix, Fluarix, Shingrix, Menveo, Engerix-B, and Boostrix. vaccines were administered to patients after freezing temperature occurred.  The reporter stated that temperature occurred on 15th Oct 2022. Additional Supportive information: The patient received reported that below recommended temperature of 28.6F for Havrix, Fluarix, Shingrix, Menveo, Engerix-B, and Boostrix which led to incorrect storage of drug.
On March 23rd (12 days afterinjection), in the morning, I noticedthat the injection site was red, hot tothe touch, and slightly painful withapplied pressure. I noticed it again inthe evening when it became slightlyitchy.; On March 23rd (12 days afterinjection), in the morning, I noticedthat the injection site was red, hot tothe touch, and slightly painful withapplied pressure. I noticed it again inthe evening when it became slightlyitchy.; On March 23rd (12 days afterinjection), in the morning, I noticedthat the injection site was red, hot tothe touch, and slightly painful withapplied pressure. I noticed it again inthe evening when it became slightlyitchy.; On March 23rd (12 days afterinjection), in the morning, I noticedthat the injection site was red, hot tothe touch, and slightly painful withapplied pressure. I noticed it again inthe evening when it became slightlyitchy.; This is a spontaneous report from a contactable consumer, the patient. This report received from a 51-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine; lot number: EN6199) via unspecified route of administration in left arm on 11Mar2021 at 13:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and intermittent tachycardia. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), liothyronine (MANUFACTURER UNKNOWN) from an unknown date for hypothyroidism and multivitamin (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient was allergic to macrobid, cow dairy and isothiazolinone. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not tested for COVID-19. On 23Mar2021 at 11:00 (12 days after injection), the patient experienced injection site hot to the touch, injection site itchy, injection site painful and injection site red.  It seems to be a recurrence of the initial reaction, which went away after three days on an unspecified date. The clinical outcomes of the events injection site hot to the touch, injection site itchy, injection site painful and injection site red was not recovered.   No follow-up attempts are needed. No further information is expected.
04/23/07 Mom stated right leg redness yesterday, this am  increased to 4" diameter dark redness with purple edges, swollen.   Mother states diagnosis of cellulitis per PA. Rx for Kislex 250mg tid x 7d.  05/02/2007 Redness clear in 5 days.
PATIENT FELT DIZZY IMMEDIATELY AFTER VACCINATION,  STARTED SWEATING PROFUSELY,  FELT THIRSTY.  HIS BODY WAS WARM AND  WANTED TO LIE DOWN.  HE LIED DOWN WITH FEET ELEVATED.  STARTED FEELING BETTER AFTER 15 MINUTES.
Patient got his vaccine and was waiting in the waiting area and about five minutes later, he temporary loss consciousness for about a minutes. After about a minute, he full regained consciousness and EMS was called. He was taken to the hospital for further evaluation.
ASYMPTOMATIC COVID-19; This spontaneous report received from a consumer via a company representative concerned a 37 year old male. 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 not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 01-OCT-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 04-OCT-2021, the patient experienced asymptomatic covid-19. Laboratory data included: COVID-19 virus test (NR: not provided) positive (twice). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000195927.; Sender's Comments: V0; Medical assessment comment not required as per standard procedure as case assessed as non-serious.