chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; fever; chills; headache; arm started to feel sore; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), Pain in extremity (arm started to feel sore), Oropharyngeal pain (sore throat), Pyrexia (fever) and Headache (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).  On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 18-Jan-2021, the patient experienced CHILLS (chills), Pain in extremity (arm started to feel sore), Oropharyngeal pain (sore throat), Pyrexia (fever) and Headache (headache).   At the time of the report, CHILLS (chills), Pain in extremity (arm started to feel sore), Oropharyngeal pain (sore throat), Pyrexia (fever) and Headache (headache) 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. No treatment information was provided.
Pt had fever on 6/26/18, ended up in the ER on 6/27/18. In ER pt was treated for cellulitis with Keflex. Area where immunization was given on L thigh was red, raised and hard measuring 3 cm in diameter  with 3 additional smaller firm red raised bumps.
soreness; pain at the injection site; This is a spontaneous report from a Pfizer-sponsored program. A non- contactable male consumer (patient) received 1st dose of BNT162B2 (COVID-19 vaccine) on 08Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. He received the 1st dose of the Covid-19 vaccine yesterday, the HCP told the caller to avoid taking Aspirin and Tylenol for 3 days. Caller wanted to have a quick review on that. Experienced a little soreness and pain at the injection site. Getting better now. Outcome of the event was recovering.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
hypertensive ermergency/ encephalopathy causing acute confusion, Narrative: Admitted for acute confusion related to hypertensive emergency one  day following second dose of COVID-19 vaccine. Hospital notes reviewed. No correlation with COVID vaccine noted as a concern per providers. Reported given timing of vaccine + hospitalization. History of HTN. Recent diagnosis of  lacunar stroke (between COVID-19 vaccine dose 1 and 2).
Hives and blisters up both arms. Treated with BENADRYL 25mg x 2 doses and antibiotic cream to blisters.
Nausea, severe headache,body aches,large knot,swelling and very red at injection site.
Vaccine was injected into shoulder- above deltoid- likely into bursa. Injector seemed nervous-alarmed upon penetrating needle into firm shoulder tissue but attempted to remain calm. Severe constant shoulder pain that evening following injection and worsening over first 48 hours. Includes significant loss of range of motion for 5 days with no improvement.  Seating pain upon attempt to lift left arm. No pin in arm or shoulder prior to vaccine booster on 1/16/22.
This spontaneous report as received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions and concomitant medication provided. On an unknown date in December 2015 (reported as on or about 17-DEC-2015), the patient was vaccinated with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot# and expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not specified). On an unknown date in December 2015 (reported as on or about 22-DEC-2015), the patient was treated for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
mom started to leave clinic returned to office stating pt was devel hives & having diff breathing;epig given;cold wet compress applied to lt deltoid inj site;airway maintained w/assistance;911 called taken to hosp;
left shoulder pain with overhead activity, painful range of movement, no signs of infection, mild symptoms improving but not going away  PT referral, orthopedics sport medicine referral, sulindac 200 mg tab, prednisone 20 mg tab
pt recvd flu vax & several hrs later, devel a swollen lt wrist which felt warm to the touch; pt c/o aching which was not relieved by application of heat to the site;
Dizziness and near faint; unsteadiness; headache, three days after shot.
Medication:paxlovid; Medication:paxlovid; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Adhesive Tape" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Medication:paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
On Monday, I noticed the symptoms: coughing, runny nose, just not feeling good. Tested positive on Tuesday, 10/26/2022. On Wednesday, 10/27/2022 I reached out to my doctor, and they prescribed PAXLOVID. I started feeling better on day one. I completed the course of 5 days.
One week later, developed soreness and a localized skin rash with a small fever. The rash is only around the injection site.  Arm feels hard under the skin.
Pneumococcal vaccine causes a localized sting on site of injection also a golf size knot. One hour later a localized area of redness and swelling and pain. Stiff arm end musles in arm very hot to the thouch. Also a fever of 100'4.  1/29/08 Reviewed hospital medical records which reveal that on 1/10/08 patient experienced abdominal pain & rectal bleeding.  Admitted 1/10-1/14/2008.  GI consult done & revealed epigastric pain, reflux, constipation & dysphagia.  No record of vaccinations w/hospitalization.  1/16/08 Returned to ER w/pain & swelling of left deltoid which stated was from flu shot received 1/14 in hospital.  Exam revealed erythematous rash, pain, paresthesias, swelling of left bicep & tricep w/decreased ROM.  Tx w/oral antibiotics & d/c to home on continued antibiotics to return next day for re-check. FINAL ER Dx: cellulitis left upper arm. 1/17/08 Returned to ER for re-check.  Exam revealed left upper arm mostly in left posterior elbow was red, hot, swollen & painful w/decreased ROM.  Tx w/additional antibiotics.  To return if worsened. FINAL ER Dx: abscess, allergic reaction, cellulitis & local reaction to flu shot.
Fever, extreme fussiness, fast breathing and reported change in color and level of alertness starting in the evening after receiving vaccines. PE-NL in office except for intermittent fussiness/crying.
No additional AE; Nurse Practitioner called and reported that a dose of VAQTA expired on 14JAN2023 and was administered on 25JAN2023. The product had no temperature excursions through date of administration. No additional AE reported. No PQC reported. No additional in; This spontaneous report was received from a nurse prescriber regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-JAN-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot #U021561, expiration date: 14-JAN-2023) (Expired product administered) for prophylaxis (strength, dose, dose number, anatomical location and route of administration were not provided). It was  reported that the product had no temperature excursions and no additional adverse events were reported.
Due to an error in mixing the vaccine the patient did not receive the vaccine, only the diluent
Temperature started on 8/5/06 of 104.  Fever ended on 8/8/06.  Also had rash for 2 days starting on 8/7/06.
The patient self-reported this adverse reaction through the hospital electronic reporting system.  In the patient's own words, "After receiving the COVID vaccine, I became very dizzy and weak. I felt like I was going to pass out more than once. Arms, legs, hands, and feet tingled, then went numb. Heart started racing, and I felt warm all over. My coworker told me I was very pale. I looked up reactions on the site and decided go to the ER and get checked. On the way over, I become slightly SOB. Once there my BP and HR was elevated, but after about an hour or so returned to normal. I still felt very weak and had some hand and leg tingling".
From telephone correspondence received on 10/30/02, it was reported that a 43 year old female adult received Fluzone, lot # U0918AA, on 10/16/02. She later complained of a sore elbow and was seen by her doctor who diagnosed it as bursitis. On 10/30/02, her arm developed red streaks at the injection site, which her physician described as cellulitis. She received 7 Rocephin IM injections and was placed on antibiotics. It was not reported whether the patient recovered.
pt recv vax 17OCT96 & 4hr p/vax pt exp chest pain & a lump in throat;pt taken to ER & given DPH;EKG nl;pt was not hosp;pt has recovered;MD felt was reflux problem;
Patient indicated he awoke at approx. 0300 to a itching sensation and noted his injection site was red and edematous, this was approx. 15 hours after initial injection, no c/f/n/v/sob/burning sensation/not warm to touch, urine output not affected.
Bell?s Palsy. Slight drooping on right side of face observed by family within 2 weeks of vaccines. Significant experience of facial weakness/paralysis experienced on 5 weeks later and Bell?s Palsy diagnosed during Emergency Room visit.
This spontaneous report was received from a physician refers to an approximately 4 month old patient of unknown gender. No concurrent condition or medical history was reported. On 20-JUL-2105, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration not provided). No concomitant therapy was reported. It was reported that the vaccination was outside of the recommendations in the PNEUMOVAX 23 prescribing information. The physician stated that the event may have been reported previously by an unspecified person. No adverse effects was reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Breakthrough case admission after three doses Moderna 2/24/21 Lot# 010A21A Moderna 3/24/21 Lot# 017F21A Moderna 11/24/21 Lot# J000429
Sinusitis & fussy-9-15-15. Acute respiratory infection & otitis media - 10-2-15. Gastroenteritis- 11-6-15.
VOMITING; FEVER; POUNDING IN HEAD; NAUSEA; This spontaneous report received from a patient concerned a 26 year old female. The patient's height, and weight were not reported. The patient's past medical history included irritable bowel syndrome, and concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included patient do not have known allergies, patient do not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 13:30 for prophylactic vaccination on right arm. Concomitant medications included cannabis sativa for irritable bowel syndrome.  On 02-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 degree F. On 02-APR-2021 14:30, the subject experienced pounding in head. On 02-APR-2021 15:30, the subject experienced fever. On 02-APR-2021 17:30, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 02-APR-2021 17:30, and pounding in head, was recovering from nausea, and had not recovered from vomiting. This report was non-serious.
Presented with SOB; Intubated by EMS PTA; Dx Covid PNA; CXR: patchy infiltrates bilat; Labs: D-dimer: 2.06; CRP: 13.26; Procal: 0.23; Ferritin: 633  Tx: Maxipine, Rocephin, Zithromax, Decadron (10 days); Toci x1; lovenox, levo intitally, extubated 2/1/22; back to baseline of 4L NC upon discharge
The following are notes of doctors from his er admission the day after the injection and the day of the patient's death.  74-year-old male with multiple health problems presents to the ED via ambulance with chief complaint generalized weakness, difficulty ambulating and history of fall x2 within the past 24 hours.  Patient had Covid 19 booster shot on Friday and his current symptoms started Saturday morning. Typically uses W/C and walker for ambulation.   Patient denies fever or chills.  No chest discomfort.  Patient states baseline shortness of breath.  No new cough.  No new onset abdominal pain and no urinary symptoms.  Patient does complain of mild pain to the right hip and right knee resulting from his previous fall.  No head injury.  No loss of consciousness.  Current GCS is 15.  Past medical history includes: Chronic atrial fibrillation on Eliquis, CAD/CABG/cardiac stents, CHF, CKD(baseline GFR 20), GERD, COPD, OSAP--nighttime O2, prior DVT/IVC filter, diabetes, obesity, prior admit for symptomatic anemia requiring blood transfusion  Code summary.  I was called to the bedside at 2023 for cardiac arrest.  Nurse states that patient was admitted yesterday for generalized weakness and falls and had been doing well but became unresponsive while she was talking to them.  He began having agonal respirations.  He was noted to be pulseless and CPR was started.  Upon my arrival CPR was in progress and patient was being bagged.  He was having agonal respirations and initially was noted to be in sinus rhythm.  He subsequently went into ventricular fibrillation and was shocked multiple times.  He was given multiple medications including amiodarone, calcium, epinephrine and bicarbonate.  Patient was intubated using video laryngoscope and 8 oh ET tube.  Patient had bilateral breath sounds and positive capnography.  Despite multiple rounds of medications and defibrillation's patient had no return of spontaneous circulation.  Another defibrillator was even brought into the room for dual sequential defibrillation with no change in rhythm.  Time of death was noted to be 2047.  I called the son and advised him of his father's passing. Wife states patient began feeling unwell the day after the injection and rapidly declined. She is concerned his death is a result of it.
On Friday evening after the injection: Within minutes of injection: pain in arm - injection site. Continued for several days afterwards. Within 10 minutes: tongue tingled and went numb. Continued for several days afterwards.  Within 20 minutes: upset stomach for the remainder of the evening. Within an hour: Fever, chills, full body muscle aches, fatigue. Slept for several hours over 2 days. Resolved by Sunday evening (roughly 48 hours).
Information has been received from a Licensed Practical Nurse (LPN) for the pregnancy registry for Gardasil concerning a 19 year old female (last menstrual period was early May 2007) with no pertinent medical history, drug reactions or allergies who on 16-MAY-2007 was vaccinated with her first dose of Gardasil, 0.5 ml, intramuscular administration (IM), and was subsequently determined to be pregnant.  There was no concomitant medication.  The LPN reported the patient did not experience any problems.  Product Quality Control (PQC) was not involved.  Follow-up information has been received from a pregnancy questionnaire.  The patient, with no past medical history or conditions, had no complications during pregnancy, diagnostic test during pregnancy or during labor/delivery.  However, 38 weeks from LMP, the patient had a cesarean section due to failure to descend.  On 20-JUN-2007 and 22-AUG-2007 the patient had an ultrasound (results WNL) due to new OB and 18 weeks U/S.  It was reported that the patient declined to have a MSAFP test.  On 23-JAN-2008 a normal female baby was born at 7 lbs 7 oz with an APGAR score of 5/9.  Concomitant medication during pregnancy (JAN-2005 through February 2008) included prenatal vitamins ("Tandem") once a day for pregnancy.  No previous pregnancies were noted.  Upon internal review cesarean section due to failure to descend was considered to be an other important medical event.  Additional information is not expected.
This spontaneous report was received from a healthcare worker refers to male patient of approximately 1 year old. No information on concurrent conditions and medical history was reported. On 23-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (unknown strength, route and dose) lot # K007107 with an expiry date of 16-MAY-2016, stored at improper temperature (51.6 degrees). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Experienced Redness, swelling, pain. On 11/22/2017 went to Emergency Room; physician prescribed  cephalexin to rule out cellulitis and  advised to return if symptoms worsened. Symptoms did worsen and patient returned to E.R. in evening and was admitted for acute cellulitis and was inpatient at hospital for 5 days. Discharged with 2 antibiotics: doxycycline and moxifloxacin. Patient came to Pharmacy this evening (11/27/2017) to discuss chain of events. He seems to be doing much better now.
Fever/chills starting 10/23/02. Night sweats 10/23 through 10/25. Red rash all over body for 2 days starting yesterday. No sore throat, some abdominal cramping. Hasn't seen doctor yet.
Vulvar ulcers; hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2) (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: VULVAL ULCERATION (non-serious), outcome "unknown", described as "Vulvar ulcers"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient was not diagnosed with COVID prior to vaccination. Patient was tested Covid post vaccination and was negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
anaphylaxis (SOB, rash, diarrhea, nausea, myalgias) within 24 hours of vaccine administration
Misread age on consent form. I thought 2004 was 2001. Patient not over 18 years of age.
This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect from a contactable consumer (the patient).  An 81-year-old female patient reported for herself that she received PREVNAR 13, via an unspecified route of administration on 21Nov2016 at single dose in right upper arm for immunisation .  No other vaccines were administered concomitantly or within 4 weeks. Medical history included blood pressure abnormal, type 2 diabetes mellitus, anxiety, insomnia, knee surgery and bilateral pneumonia in latter part of 2013.  The patient previously took pneumococcal vaccine in Jan 2014, and Flu shot every year. The patient reported that she never had pneumococcal 13-val conj vac (dipht crm197 protein) before. Concomitant medication included lisinopril (unknown manufacturer) started a year or more ago for blood pressure, metformin (unknown manufacturer) for type 2 diabetes started two years ago, sertraline hydrochloride (ZOLOFT) started taken at least 2 or 3 years ago for anxiety and insomnia (she took care of grandson and she got anxiety and could not sleep at night), atorvastatin (unknown manufacturer), tramadol (unknown manufacturer) for knees because knee surgery did not correct the problem. The patient experienced feeling hot and cold on 22Nov2016, chills on 23Nov2016, muscle weakness on 24Nov2016, muscle pain on 24Nov2016, dizzy on Nov2016, sweating on Nov2016, headache on 22Nov2016, no energy on Nov2016, flu like symptoms on Nov2016. All the events recovered at the end of  Nov2016. The events did not require a visit to emergency room or to physician office. The patient underwent lab tests and procedures which included nuclear magnetic resonance imaging  months ago to follow up on knee.  Therapeutic measures taken as a result of flu like symptoms included treatment with TYLENOL.
6:00 pm - severe headache, very lethargic. Gave Tylenol and sent to bed. Beginning 8/5 - 8/9 patient starts complaining of headaches daily, worse by eveningtime. 8/10 Severe headache, sore, nauseated, vomiting. Dad comes home from work 8/11-8/23 vomiting ceases, still having dull headache complains its low towards her neck. Tylenol seems to relieve the pain, otherwise acting normal. 8/24 severe headache, in tears, complaining that her neck hurts. (this is the second day of school, she insists she will be fine does not want to miss school) 8/25 - 8/28 symptoms the same headache neck is getting more stiff. 8/29 comes home from school in tears, severe headache, can't turn her head, had an episode of double vision during PE at school. We go to ER. ER does blood work, Xray neck and CAT Scan. Says her neck might be sprained, gave her ibuprofen and sent her home. 8/30 symptoms are worse than evening before, neck is swollen on back right side at base of head, trouble focusing, says her head feels heavy. We return to the ER, they give her Tylenol 3 say she needs to see her pediatrician. 8/31 see pediatrician (nurse prationer, dr. out of office) she says possible strep, gives antibiotics and sends home. 9/1 - 9/3 no change in symptoms now have periodic double vision. 9/4 wake up she has constant double vision. Dr. sends us to ER.
Heart palpitation, drop in o2, elevated heart rate, 147, could not sleep or eat and having psychological issues. Lymph node swelling in neck, Multi-vitamin, Vitamin D, Alpha lipoic acid. Burning on back of arm at the lower injection site. Heart pounding and anxiety and missed pain medication.