chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever on and off; arm  pain; body aches; chills; joint pain; This is a spontaneous report from a contactable nurse who was also the patient. A 55-year-old female patient received bnt162b2, lot:EK9231, via an unspecified route of administration on 23Dec2020 at an single dose for covid-19 immunisation. The patient's medical history was none. The patient's concomitant medications included unspecified vitamins. On 23Dec2020, the got the vaccine and the fever (on and off) started that night and had some arm pain too. The patient also had body aches, some chills and joint pain in Dec2020. The nurse stated that the thing should have gone better. She was just wondering how long she could have that side effects because it's been 3 days. Therapeutic measures were taken as a result of fever on and off pyrexia, body aches pain and chills were Tylenol and Motrin (patient did not clarify the improvement after taking the treatment). The outcome of the events was not recovered at the time of the report.
That evening developed itching and had a rash over upper body and arms, still on arms in AM, went away on it's own, since then have episodes of chills and a trigger finger developed while sleeping on right #4 digit of Right hand, tightness in chest and last night developed pain in left  arm and fingers that was very painful and did not respond to 800mg of Ibubrofen. Not sure if related.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 15May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left leg for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 DM" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient had no known allergies. The patient had other medication in 2 weeks since vaccination. Paxlovid was given as treatment from 30Jun2022 to 04Jul2022. It seems patient had rebound symptoms: aches, chills, sore throat, mild fever (99.2-99.5F), after taking paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Pfizer vaccine was administered  - reported by patient- NO LOT NUMBER WERE SUPPLIED ACUTE RESPIRATORY FAILURE 11/18/2022 POST OBSTRUCTIVE PNEUMONIA
flu; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).   This case involved a patient of unknown demographic, who experienced flu (Influenza), while the patient received Influenza Vaccine.  Medical history, past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site.   On an unknown date, the patient had non-serious flu (Influenza) unknown latency following the administration of INFLUENZA VACCINE. Patient stated that every time after getting the flu shot patient ended up with the flu. Patient stopped taking flu shot and did not get flu anymore.   Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
severe ice pick headache; not feeling well; soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (not feeling well), PAIN (soreness) and HEADACHE (severe ice pick headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (not feeling well) and PAIN (soreness). On an unknown date, the patient experienced HEADACHE (severe ice pick headache). At the time of the report, ILLNESS (not feeling well), PAIN (soreness) and HEADACHE (severe ice pick headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
I woke up unable to bear weight on my left leg. There is a great deal of pain my left knee. I can walk, but bearing weight is very painful and sometimes makes me fall over. My balance is usually good but not since this event.
Localized wheal (raised erythemic patch 2x3") near influenza injection site in L upper arm developed 20 hours after vaccination. No other symptoms. Treatment included Kenalog.
NASAL CONGESTION      "im congested and I have aches and pains and im throwing up" ? Corona Virus Concern     a 63y.o. female with a past medical history of asthma, hypertension, osteoarthritis presenting today for nasal congestion and coronavirus concern. Patient states that she has had more than 7 episodes of nonbloody nonbilious emesis tonight. She is also complaining of epigastric and right upper quadrant abdominal pain. Patient's family member has had a cold for the past week and patient states that she feels febrile and congested for the past few days. Patient is fully vaccinated for coronavirus. Has not taken any medications prior to arrival.
This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age and gender who on 25-SEP-2015, was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L023118, expiry date 24-SEP-2016). No adverse event were reported. Additional information has been requested. Lot number L023118 is a valid lot number for ZOSTAVAX.
Quadracel was inadvertently given to 2 year old; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 2 years old patient (gender not reported) who was vaccinated with a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administered.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none
Seven days after I received the vaccine my arm was swollen, red and itchy at the injection site.
1 hr after vaccine - dev throat tightening, headache, 24-48 hrs of congestion, eyes swollen.
The child developed a fine rash starting over the right trunk and progressing over trunk at neck. No respiratory distress. Onset of this was within 1-2 minutes of injection. The pt also had about 3cm area of redness, erythema and mild swelling around the IPV shot site. The rash resolved within 60 minutes.
Per parent, sx started around noon with nausea. Progressed to "stomach burning and hurting", dizziness and a sore throat around 3pm. 9:41pm reports headache, sore throat, shaking, congestion, eyes burning and vomiting after eating and drinking.
39 yo m with h/o HTN presents to the ER with c/o blood in his urine which started this morning. Says that he started taking lisinopril and hydrochlorothiazide about 1 week ago. Also says that he has noted a rash on his legs and chest for the past 4 days. Dexamethasone mg every day, globulin, immune 90 gm every day.
devel h/a 2 days p/2nd dose & also c/o muscles aching; took APAP as needed for h/a;
HAVING A LITTLE BIT OF CHILLS; RUNNY NOSE; ALLERGIES; This is a spontaneous report from a non-contactable consumer (patient himself) via a Pfizer-sponsored program,  Program. A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization and started to receive tofacitinib citrate (XELJANZ XR, 11 mg prolonged-release tablet), via an unspecified route of administration from an unspecified date in Nov2020 and ongoing, at unspecified dosage and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient reported that he got the COVID-19 vaccine and on an unspecified date he was having a little bit of chills. The patient also reported having a runny nose and had allergies on an unspecified date. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
Syncopal episode after Gardasil #1 (pale, clammy, slid to floor?, hit head-easily aroused B/P 105/55 pulse 70). Within 5 min, assisted to chair, sipping soda, lying on fathers shoulder became faint again.... Assisted to exam room/ within 20 min able to sit without dizziness or complaints. Home with father. No complaints best day when follow up call made.
This spontaneous report was received from a registered nurse, and refers to a 12 months old female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 26-MAR-2016, the patient was vaccinated at the same time with a dose of VARIVAX (Merck) (dose, frequency, route, lot # and expiration date were not reported) and a dose of PROQUAD (Merck) (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected as the reporter did not allow to be contacted.
Fever blisters and swelling of upper left arm. Elevated temperature (104 degrees) at the ER. Treated for an allergic reaction - told to take BENADRYL, TYLENOL, and increase fluid intake.
Patient reported that area where injection was given originally bruised. He said the bruise then "ran down the muscle".  Injection given in left deltoid -- large bruise on inside of left arm evident on 10/11/2010 when he returned to pharmacy to pick up a prescription. He agreed to allow Pharm D to photograph & told that he had showed it to his MD that had administered the corticosteroid shot.  He stated that MD told him it was a bruise & he did not seem too concerned.  Follow up on 10/13/2010 with pt on phone & he states bruise remains approx. the same as when he brought it to our attention. Pharm D asked if he was taking any blood thinners (i.e. aspirin, etc.) and he stated that he has been on Naproxen 500mg twice daily for the past several weeks.
thur 5/6 800am_ woke up feeling very shaky from head to toes legs were tight when trying to stand up and felt my heart pulsating rapidly which i had to sit down and take deep breaths to calm my heart i was out of breath when walking /blood pressure was high/front neck was a bit swollen and tight/ my left arm which i had gotton the shot on had a red bump and was painfull to touch i massaged it andthe pain was gone/i had no chest pain / i had a lymph node that appeared below my left ear the size of a dime it was painful to the touch and reduced in size and pain on tues 5/11  fri 5/7 intence shaky especially when trying to sleep only 1 hour of sleep/same symptoms continued from 5/6  wed 5/12 8:30am went to see a doctor in the morning feeling high blood pressure/intense shaking/rapid pulsating heart/ doctor took blood work /ekg test and results were normal just had a high blood count/high cholesterol which i already knew but i never had any medical issues before and doctor stated it was normal to get a lymph node swell after getting a vaccine /she recommended a diet and medication or omea 3 vitiamin for my high cholesterol  thurs 5/13 7:00am starting getting new symptoms heachaches /backpain /front of neck tightness moved to back of neck pain /pain was reduced with help of massage and low dose aspirin   fri 5/14 8:00am while donating plasma lying down my legs were getting tight and i started to move my feet up and down slowly to help with my cirulation and my heart rate jumped up to 180 which showed on my smart watch my so i stopped and took deep breaths to reduce my heart rate   sun 5/23 still feeling shaky and has not stopped but not as intense/ heart feels pulsating rapid but decreased in intensity/ i always take deeps breath now /head /back of neck/back pain and leg tightness are still there but they feel better when massaged and i have an appointment to see a chiroprator to help with the pain and tightness on moday 5/24 and hopes of helping my shaking and see how my heart feels after /my sleep in now at 3-4 hours max with the help of low dose aspirin and melatonin
Metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; very vivid dreams every night-sometimes nightmares, usually don't remember dreaming at all; This is a spontaneous report from a contactable Other-HCP (patient reported herself). A 42-year-old non-pregnant female patient received BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration on 29Jan2021 12:00 PM at single dose to her left arm for Covid-19 immunization. She was allergic to Sulfa-thrush. No Covid was tested prior or post vaccination. Concomitant medications included (BENADRYL) every night and paracetamol (TYLENOL) 1-2 times a week bef. On 29Jan2021, the patient experienced metallic taste strong at time of vaccine, every day afterwards sometimes with eating sometimes not with food, very vivid dreams every night-sometimes nightmares, usually did not remember dreaming at all. She did not take any treatment in response to the events. Outcome of the events was not recovered.
After the first shot mild fatigue from 2-3 day post vaccination, up to the second vaccination.  After the second dose of the vaccine to the present time EXTEME FATIGUE AND DISSINESS ALL DAY LONG, along with a FOG FEELING IN THE HEAD ALL DAY LONG.  tHIS IS going on up to today ,July 29, 2021, when will it get better ?
This spontaneous report as received from an unspecified reporter, via social media, refers to a female patient of unknown age. The event was described in an online article. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an unidentified HPV vaccine (manufacturer unknown) 1 shot (name, lot number, route and site of administration were not provided). On an unknown date, the patient died. The author of the online article had the patient's death as HPV shot related, however it was proved to be false. The reporter's causality assessment between death and unidentified HPV vaccine (manufacturer unknown) was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as no contact details were provided.
Fever, Chills, Arthralgia Wrist and Hand Edema ,Bilateral Shoulder pain and right knee pain
Patient said he is experiencing shooting pain and numbness in his left arm.   The same as the injection site.  It has been 34 days since his vaccination.
Patient is a 95 y.o. female patient of DO with history of AAA, iliac aneurysm, OA, atrial fibrillation, hypothyroidism, HLD, and HTN who presented to a local Hospital with dyspnea, cough, and found to be in atrial fibrillation with RVR and have COVID.      Discharge Diagnoses:   Acute metabolic encephalopathy In setting of COVID, UTI, had intermittent episodes of delirium with hallucinations B12 <400, TSH normal, vit D mildly low CT head on admission without acute intracranial abnormalities B12 and vit D replacement initiated Seroquel scheduled nightly Mentation overall improved at time of discharge     Acute cystitis Urine showed positive nitrate and moderate WBC Prescribed Keflex as outpatient, but did not pick up prescription prior to being admitted Urine culture 2/14 with >100K Citrobacter freundii Bactrim 5-day course completed on 2/22   Acute respiratory failure with hypoxia, resolved Respiratory failure secondary to COVID  O2 sat 86% on room air on admission Mild leukocytosis on admission with mild lactic acidosis CXR with left basilar consolidation, possible small left pleural effusion Procalcitonin normal Urinary antigens negative Initially required NC O2, but now off oxygen       Covid-19 Virus Infection Date of onset of symptoms: 2/10/2023 Symptoms present on admission: Dyspnea, cough Date of covid positive test: 2/13/2023 Vaccination status: vaccinated, boosted Imaging: as above with basilar consolidation Oxygen requirements on admission: 2L NC O2 Current oxygen requirements: room air Medical therapy: received decadron, discontinued when no longer requiring supplemental O2 Consultants following: None Special isolation end date: 2/21/23 Inflammatory markers not elevated   Atrial fibrillation with RVR Has underlying atrial fibrillation, likely exacerbated by acute infection HR on admission in the 140s Echo (5/4/22): LVSF normal, EF 65%, no wall motion abnormality, no significant valvular disease Received IV metoprolol in ED, then started on diltiazem drip.  Drip discontinued when rate improved. Increased Toprol-XL to 200 mg, rate now better controlled Conintued xarelto   CKD3 Creatinine 0.86 at time of discharge   Hypothyroidism Continued outpatient Synthroid   Dizziness/vertigo Meclizine provided as needed   Bilateral feet pain Normal exam Ibuprofen given as needed Pain improved prior to discharge   Goals of care Previously living at home with son, but has become more difficult to manage due to dementia.  Family requesting discharge to SNF for rehab, but expressing some concerns regarding long-term management.  Discussed with daughter, who feels patient has been declining significantly.  Patient currently DNR CCA.  Palliative care consulted and assisted family with decision making.
4 cm x 7 cm redness, warmth. Put on Avelox & Zyrtec
Numbness and tingling sensations in both hands and sometimes radiating up my forearms, more severe in right hand and right thumb; these symptoms still didn?t go away since 1/11
Administered Shingrix instead of Menveo; a 16 year old was administered shingrix instead of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old male patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   Additional patient notes included the patient was not immunocompromised.   On 10-AUG-2023, the patient received the 1st dose of Shingrix. On 10-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Administered Shingrix instead of Menveo) and inappropriate age at vaccine administration (Verbatim: a 16 year old was administered shingrix instead of Menveo).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 A 16-year-old was administered Shingrix instead of Menveo, which led to Wrong vaccine administered and Inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 2 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023119224:2nd Report
This case was reported by a healthcare professional and described the occurrence of swelling of legs in a subject of unspecified age and gender who was vaccinated with (INFANRIX, GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of INFANRIX (.5 ml, unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced swelling of legs, nodule at injection site, redness, painful to walk and pharmaceutical product complaint. The reporter could not recall other details, but strongly felt there was a quality issue with INFANRIX because she has not seen there events occur so often over the last four years she has worked within the practice. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events probably related to vaccination with INFANRIX.
Initial consumer (patient) report received on 30 Nov 2010: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch number: unknown) 0.5 ml dose, on 03 Oct 2010. The patient started feeling sick, with constant headaches on 05 Oct 2010. 11 days later on an unknown date, she developed body aches, fever and cough which lasted for about 14 days. The patient also presented with severe rash on her thighs and lower abdomen, lost weight (10 pounds) and developed a severe urinary tract infection (UTI) on 25 Oct 2010. The events resolved but the patient was still little weak at the time of reporting.
I had body aches and felt feverish. This lasted for the entire day after. I took Tylenol through the day and felt better the next day.
The patient is a 55 yo female who presented to the site for her second dose, after waiting for 15 mins on general observation while on her way to the parking lot w/ her husband she experienced what she described as a sensation of feeling dizzy and lightheaded, she returned to the floor and was evaluated by me and EMS. On Exam patient alert and oriented X 3 able to follow command, mood normal, talkative, Eyes: EOMI, PERRLA, lungs clear, heart RRR, S1 and S2 normal, no murmurs. BP; 122/87  Po2 99, HR 82.  She denied having taking her medications and didn't hydrate or had breakfast prior.  Denied  nausea, and vomiting. Patient was closely monitored for 30 minutes and was given water for hydration.